Type2diabetesPhase 4NCT06449235
Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh
A Phase 4 study testing Omarigliptin, Sulphonylureas and Metformin in people with Type2diabetes, run by Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders at 1 site in Bangladesh.
Trial summary
The study titled "Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh" aims to assess the real-world effectiveness and safety of omarigliptin in managing newly diagnosed type 2 diabetes mellitus (T2DM) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Omarigliptin, Sulphonylureas and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 938 participants
- Where
- 1 siteBangladesh
- Study dates
- Sep 2024to Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed T2DM (according to American Diabetic Association, ADA guideline) aged (≥ 18 years) treated with stable doses of antidiabetic medications (with or without omarigliptin) along with standard diet and exercise
- HbA1C ranged ≥7.0% and ≤10.0%
- Stables doses of drug at least 4 weeks
Who cannot join
- Newly diagnosed T2DM who will be prescribed insulin for diabetes management
- History of significant weight loss in past 6 months (more than or equal to 5 kg in 1 month)
- Hypersensitivity to any antidiabetic drug
- Type 1 diabetes, a history of ketoacidosis,
- Active liver disease,
- Significant cardiovascular disease,
Show all 18Show fewer
- A history of malignancy,
- Hematological disorders
- Omarigliptin at any time.
- Any acute condition (acute coronary syndrome, acute stroke etc.)
- Pregnancy and lactation
- eGFR) <30 mL/min/1.73 m2
- ALT (alanine aminotransferase)->2 times the upper limit of the normal
- AST (aspartate aminotransferase)->2 times the upper limit of the normal
- TSH-increased or decreased than the normal range
- Hemoglobin <11 g/dL (male) or <10 g/dL (female),
- Triglycerides >600 mg/dL, or
- C-peptide <0.6 ng/mL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh
The study titled "Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh" aims to assess the real-world effectiveness and safety of omarigliptin in managing newly diagnosed type 2 diabetes mellitus (T2DM) patients. Conducted at BIRDEM General Hospital, this 12-month observational study involves 938 patients aged 18 years or older, newly diagnosed with T2DM, with no prior use of antidiabetic medications.
T2DM is a growing global health concern, necessitating effective treatment strategies. Omarigliptin, a once-weekly DPP-4 inhibitor, has shown promising results in clinical trials worldwide. However, its real-world efficacy and safety in diverse populations like Bangladesh remain under-explored. This study aims to fill this gap by evaluating omarigliptin in a typical clinical setting in Bangladesh, potentially providing valuable insights for healthcare providers.
Read more
Study Objectives: To assess the real-world efficacy and safety of omarigliptin in managing newly diagnosed T2DM. Specific objectives include evaluating glycemic control (HbA1C levels), safety regarding adverse events, and other outcomes such as changes in fasting plasma glucose, electrolyte levels, liver enzymes, creatinine, and lipid profile.
Methodology: Conducted in the Department of Endocrinology at BIRDEM General Hospital over 12 months, the study population includes newly diagnosed T2DM patients divided into two groups: those receiving omarigliptin and those receiving other antidiabetic agents. Sample size calculation determined 469 patients per group, accounting for a 15% dropout rate.
Inclusion Criteria:
- Newly diagnosed T2DM (according to ADA guidelines) aged ≥ 18 years
- HbA1C levels between ≥7.0% and ≤10.0%
- Stable doses of antidiabetic drugs for at least 4 weeks
Exclusion Criteria:
- Prescribed insulin for diabetes management
- Significant weight loss, hypersensitivity to antidiabetic drugs, type 1 diabetes, ketoacidosis, active liver disease, significant cardiovascular disease, malignancy, hematological disorders, pregnancy, and severe renal impairment, among others.
Study Variables: Data will be collected on demographic variables (age, gender, socio-economic status, BMI), laboratory variables (HbA1C, fasting blood glucose, lipid profile, creatinine, electrolytes, ALT, and postprandial glucose), and adverse events (respiratory infections, headaches, gastrointestinal issues, joint pain).
Study Procedure: Patients will receive personalized antidiabetic treatment with or without omarigliptin, alongside standard dietary and exercise recommendations. Follow-up assessments will occur at 14 days, 3 months, and 6 months post-enrollment. Data will be collected through interviews, physical exams, and laboratory tests, recorded in case record forms (CRFs).
Adverse Event Monitoring: Adverse events (AEs) and serious adverse events (SAEs) will be monitored throughout the study. Participants will be instructed to record any side effects in a treatment diary and contact the study team as needed. AEs include any unfavorable medical occurrences, while SAEs involve life-threatening conditions, hospitalization, or significant disability.
Data Analysis: Data will be analyzed using SPSS Version 23. Descriptive analyses will investigate participant characteristics, with statistical significance set at p < 0.05. Parametric variables will be assessed using Student's t-test, and Spearman's correlation will be used for correlations. Regression analyses will also be performed.
Ethical Considerations: The study will adhere to the Declaration of Helsinki and other ethical guidelines. Approval will be sought from the Institutional Review Board (IRB) of BIRDEM. Written informed consent will be obtained from all participants before enrollment.
Read the detailed description
IIntroduction Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and impaired insulin secretion, leading to elevated blood glucose levels. Associated with significant morbidity and mortality, T2DM complications include cardiovascular disease, nephropathy, retinopathy, and neuropathy. With its increasing global prevalence, especially in developing countries like Bangladesh, T2DM poses substantial public health challenges.
Management of T2DM requires a combination of lifestyle modifications and pharmacotherapy to achieve and maintain glycemic control. Dipeptidyl peptidase-4 (DPP-4) inhibitors, a class of oral antidiabetic agents, enhance the incretin system, thereby increasing insulin secretion and decreasing glucagon release in a glucose-dependent manner. Omarigliptin, a novel, once-weekly DPP-4 inhibitor, has demonstrated efficacy and safety in clinical trials, but its real-world effectiveness and safety profile, particularly in diverse populations, remain underexplored.
Study Objectives The primary objective of this study is to evaluate the real-world efficacy and safety of omarigliptin in managing newly diagnosed T2DM patients in Bangladesh. Specific objectives include assessing glycemic control (measured by HbA1c levels), monitoring adverse events, analyzing changes in fasting plasma glucose (FPG), postprandial glucose (PPG), and other laboratory parameters, and comparing outcomes with other antidiabetic agents.
Methodology
Study Design:
This is an observational, real-world study conducted over 12 months at the Department of Endocrinology, BIRDEM General Hospital, Dhaka, Bangladesh. The study includes newly diagnosed T2DM patients aged 18 years or older. Participants are divided into two groups: those receiving omarigliptin and those receiving other antidiabetic agents.
Study Population:
Participants will be newly diagnosed T2DM patients attending BIRDEM General Hospital. They will be managed with either omarigliptin or other antidiabetic agents, with personalized treatment regimens decided by the attending physician based on clinical conditions.
Data Collection:
Data will be collected through patient interviews, physical examinations, and laboratory tests. All data will be recorded in standardized case record forms (CRFs). Follow-up assessments will occur at 14 days, 3 months, and 6 months post-enrollment.
Study Variables:
Demographic and laboratory variables will be recorded, including age, gender, socio-economic status, BMI, HbA1c, fasting blood glucose, postprandial glucose, lipid profile, serum creatinine, electrolytes, and liver enzymes. Adverse events will also be tracked and categorized.
Study Procedure:
Participants will receive personalized antidiabetic treatment, including lifestyle modifications and dietary recommendations. The treatment regimen, including the use of omarigliptin, will be determined by the attending physician.
Follow-Up Assessments:
Follow-up assessments will occur at 14 days, 3 months, and 6 months post-enrollment. During these follow-up visits, the following parameters will be checked:
- 14 Days:
- Review of treatment adherence and any immediate side effects
- Physical examination
- Fasting plasma glucose (FPG) levels
- Recording any adverse events (AEs)
- 3 Months:
- Physical examination
- HbA1c levels
- Fasting plasma glucose (FPG) levels
- Postprandial glucose (PPG) levels
- Lipid profile (total cholesterol, LDL, HDL, triglycerides)
- Serum creatinine
- Electrolytes
- Liver enzymes (ALT)
- Recording any adverse events (AEs)
- 6 Months:
- Comprehensive physical examination
- HbA1c levels
- Fasting plasma glucose (FPG) levels
- Postprandial glucose (PPG) levels
- Lipid profile (total cholesterol, LDL, HDL, triglycerides)
- Serum creatinine
- Electrolytes
- Liver enzymes (ALT)
- Monitoring for serious adverse events (SAEs)
- Final recording of adverse events (AEs)
Adverse Event Monitoring:
Adverse events (AEs) and serious adverse events (SAEs) will be monitored throughout the study. Participants will record any side effects in a treatment diary and contact the study team as needed. AEs include any unfavorable medical occurrences, while SAEs involve life-threatening conditions, hospitalization, or significant disability.
Data Analysis:
Data will be analyzed using SPSS Version 23. Descriptive statistics will summarize patient characteristics. Paired t-tests will analyze changes in laboratory parameters. Comparisons between groups will be made using Student's t-tests and chi-square tests. Statistical significance is set at p < 0.05. Regression analysis will identify predictors of treatment response.
Ethical Considerations:
The study will adhere to the Declaration of Helsinki and relevant local guidelines. Ethical approval will be obtained from the Institutional Review Board (IRB) of BIRDEM. Written informed consent will be obtained from all participants before enrollment.
Expected Outcomes:
The study aims to provide real-world evidence on the efficacy and safety of omarigliptin in a typical clinical setting. By comparing outcomes with other antidiabetic agents, the study will help elucidate the relative benefits and risks of omarigliptin, aiding healthcare providers in making informed treatment decisions.
- Conditions
- Type2diabetes
- Being tested
- Omarigliptin, Sulphonylureas, Metformin, Other DPP4-i, Thiazolidinediones
- Keywords
- Omarigliptin, Type 2 Diabetes Mellitus, DPP-4 inhibitor, Real world evidence, Bangladesh, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmarigliptinDrug
Chemical name: MK-3102 Class: Dipeptidyl peptidase-4 (DPP-4) inhibitor
Mechanism of Action:
Inhibits DPP-4 enzyme, thereby increasing incretin levels. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Improves β-cell function of the pancreas. Reduces hepatic glucose output. Administration: Once-weekly oral dosing.
SulphonylureasDrug
Chemical Name: Sulphonylureas Class: Sulphonylureas
Mechanism of Action:
Stimulates insulin release from pancreatic beta cells. Enhances the sensitivity of beta cells to glucose. Reduces hepatic glucose production. Increases peripheral glucose uptake and utilization. Administration: Typically administered once or twice daily, depending on the specific medication and patient needs.
MetforminDrug
Chemical Name: Metformin Class: Biguanide
Mechanism of Action:
Decreases hepatic glucose production. Improves insulin sensitivity in peripheral tissues. Enhances peripheral glucose uptake and utilization. Reduces intestinal absorption of glucose. Administration: Administered orally, usually once or twice daily with meals.
Other DPP4-iDrug
Chemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
Mechanism of Action:
Inhibits DPP-4 enzyme, thereby increasing incretin levels. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Improves β-cell function of the pancreas. Reduces hepatic glucose output. Administration: Typically administered orally once daily. Dosage may vary depending on the specific medication and patient needs.
ThiazolidinedionesDrug
Chemical Name: Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone) Class: Thiazolidinediones (TZDs)
Mechanism of Action:
Activates peroxisome proliferator-activated receptor-gamma (PPAR-γ) in adipose tissue, muscle, and liver.
Increases insulin sensitivity in peripheral tissues. Enhances glucose uptake and utilization in muscle and adipose tissue. Reduces hepatic glucose production. Administration: Administered orally, typically once daily. Dosage may vary based on the specific medication and patient response.
Alpha-Glucosidase InhibitorDrug
Chemical Name: Alpha-Glucosidase Inhibitors (e.g., Acarbose, Miglitol) Class: Alpha-Glucosidase Inhibitors
Mechanism of Action:
Inhibits alpha-glucosidase enzymes in the small intestine. Delays the breakdown and absorption of complex carbohydrates. Reduces postprandial blood glucose levels. Administration: Administered orally, typically taken with the first bite of each main meal. Dosage may vary based on the specific medication and patient response.
Glucagon-Like Peptide-1Drug
Chemical Name: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: GLP-1 Receptor Agonists
Mechanism of Action:
Mimics the action of endogenous GLP-1. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Slows gastric emptying. Promotes satiety and reduces food intake. Improves β-cell function of the pancreas. Administration: Administered via subcutaneous injection, with frequency varying from twice daily to once weekly, depending on the specific medication.
Receptor Agonists (GLP1RA)Drug
Chemical Name: GLP-1 Receptor Agonists (GLP1RA) (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: Glucagon-Like Peptide-1 Receptor Agonists
Mechanism of Action:
Activates GLP-1 receptors. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Slows gastric emptying. Promotes satiety and reduces food intake. Improves β-cell function of the pancreas. Administration: Administered via subcutaneous injection, with frequency varying from twice daily to once weekly, depending on the specific medication.
SGLT2 inhibitorsDrug
Chemical Name: Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors (e.g., Canagliflozin, Dapagliflozin, Empagliflozin, Ertugliflozin) Class: SGLT2 Inhibitors
Mechanism of Action:
Inhibits SGLT2 in the proximal renal tubules. Reduces reabsorption of filtered glucose from the renal tubules. Increases urinary glucose excretion. Lowers blood glucose levels independently of insulin. Administration: Administered orally, typically once daily. Dosage may vary based on the specific medication and patient response.
| Study group | Role | What they receive |
|---|---|---|
| Omarigliptin | Experimental | Arm A will include patients receiving omarigliptin. However, the decision to initiate omarigliptin will be at the treating physician's discretion. The dose of omarigliptin will be 12.5 mg or 25 mg, oral tablet, once weekly decided by the respective physician. Receives: Drug: Omarigliptin |
| Sulphonylureas | Active comparator | This Arm will include patients receiving Sulphonylureas (Gliclazide/ Glipizide/ Glimepiride/ Tolbutamide) according to the physician's choice. Receives: Drug: Sulphonylureas |
| Metformin | Active comparator | This Arm will include patients receiving Metformin according to the physician's choice. Receives: Drug: Metformin |
| DPP-4i | Active comparator | This Arm will include patients receiving DPP-4i other than sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin etc. Receives: Drug: Other DPP4-i |
| Thiazolidinediones | Active comparator | This Arm will include patients receiving Thiazolidinediones (Glitazones, pioglitazone, rosiglitazones) Receives: Drug: Thiazolidinediones |
| Alpha-Glucosidase Inhibitor | Active comparator | This Arm will include patients receiving Alpha-Glucosidase Inhibitor (Acarbose, Miglitol, etc.) Receives: Drug: Alpha-Glucosidase Inhibitor |
| Glucagon-Like Peptide-1 | Active comparator | This Arm will include patients receiving Glucagon-Like Peptide-1 Receives: Drug: Glucagon-Like Peptide-1 |
| Receptor Agonists (GLP1RA) | Active comparator | This Arm will include patients receiving Exenatide, lixisenatide, liraglutide, albiglutide, dulaglutide, and semaglutide etc. Receives: Drug: Receptor Agonists (GLP1RA) |
| SGLT2 inhibitors | Active comparator | This Arm will include patients receiving Empagliflozin, Ertugliflozin, Canagliflozin, Dapagliflozin Receives: Drug: SGLT2 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control as Measured by HbA1c Levels
Evaluation of the efficacy of omarigliptin in managing glycemic control among newly diagnosed Type 2 Diabetes Mellitus (T2DM) patients in a real-world clinical setting.
Measured: Baseline assessment. Follow-up visits at 14 days, 3 months, and 6 months post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 938 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Pi Research and Development Center, Acme Laboratories Ltd.
- Responsible party
- Principal investigator, Professor Dr. Feroz Amin, Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
- Investigators
- Faria Afsana, MD, Principal investigator, Associate Professor, BIRDEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449235
- Sponsor's protocol ID
- BIRDEM
- Other IDs
- BADAS-ERC/EC/24/13
- Status last verified
- Jul 2024
- First submitted
- 3 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh
- ClinicalTrials.gov ID
- NCT06449235
- Acronym / sponsor ID
- BIRDEM
- Conditions
- Type2diabetes
- Keywords
- Omarigliptin, Type 2 Diabetes Mellitus, DPP-4 inhibitor, Real world evidence, Bangladesh, T2DM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 938 participants (estimated)
- Lead sponsor
- Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic DisordersUniversity, hospital or other
- Collaborators
- Pi Research and Development Center, Acme Laboratories Ltd.
- Study start
- Sep 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study titled "Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh" aims to assess the real-world effectiveness and safety of omarigliptin in managing newly diagnosed type 2 diabetes mellitus (T2DM) patients. Conducted at BIRDEM General Hospital, this 12-month observational study involves 938 patients aged 18 years or older, newly diagnosed with T2DM, with no prior use of antidiabetic medications.
T2DM is a growing global health concern, necessitating effective treatment strategies. Omarigliptin, a once-weekly DPP-4 inhibitor, has shown promising results in clinical trials worldwide. However, its real-world efficacy and safety in diverse populations like Bangladesh remain under-explored. This study aims to fill this gap by evaluating omarigliptin in a typical clinical setting in Bangladesh, potentially providing valuable insights for healthcare providers.
Study Objectives: To assess the real-world efficacy and safety of omarigliptin in managing newly diagnosed T2DM. Specific objectives include evaluating glycemic control (HbA1C levels), safety regarding adverse events, and other outcomes such as changes in fasting plasma glucose, electrolyte levels, liver enzymes, creatinine, and lipid profile.
Methodology: Conducted in the Department of Endocrinology at BIRDEM General Hospital over 12 months, the study population includes newly diagnosed T2DM patients divided into two groups: those receiving omarigliptin and those receiving other antidiabetic agents. Sample size calculation determined 469 patients per group, accounting for a 15% dropout rate.
Inclusion Criteria:
- Newly diagnosed T2DM (according to ADA guidelines) aged ≥ 18 years
- HbA1C levels between ≥7.0% and ≤10.0%
- Stable doses of antidiabetic drugs for at least 4 weeks
Exclusion Criteria:
- Prescribed insulin for diabetes management
- Significant weight loss, hypersensitivity to antidiabetic drugs, type 1 diabetes, ketoacidosis, active liver disease, significant cardiovascular disease, malignancy, hematological disorders, pregnancy, and severe renal impairment, among others.
Study Variables: Data will be collected on demographic variables (age, gender, socio-economic status, BMI), laboratory variables (HbA1C, fasting blood glucose, lipid profile, creatinine, electrolytes, ALT, and postprandial glucose), and adverse events (respiratory infections, headaches, gastrointestinal issues, joint pain).
Study Procedure: Patients will receive personalized antidiabetic treatment with or without omarigliptin, alongside standard dietary and exercise recommendations. Follow-up assessments will occur at 14 days, 3 months, and 6 months post-enrollment. Data will be collected through interviews, physical exams, and laboratory tests, recorded in case record forms (CRFs).
Adverse Event Monitoring: Adverse events (AEs) and serious adverse events (SAEs) will be monitored throughout the study. Participants will be instructed to record any side effects in a treatment diary and contact the study team as needed. AEs include any unfavorable medical occurrences, while SAEs involve life-threatening conditions, hospitalization, or significant disability.
Data Analysis: Data will be analyzed using SPSS Version 23. Descriptive analyses will investigate participant characteristics, with statistical significance set at p < 0.05. Parametric variables will be assessed using Student's t-test, and Spearman's correlation will be used for correlations. Regression analyses will also be performed.
Ethical Considerations: The study will adhere to the Declaration of Helsinki and other ethical guidelines. Approval will be sought from the Institutional Review Board (IRB) of BIRDEM. Written informed consent will be obtained from all participants before enrollment.
Detailed description
IIntroduction Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and impaired insulin secretion, leading to elevated blood glucose levels. Associated with significant morbidity and mortality, T2DM complications include cardiovascular disease, nephropathy, retinopathy, and neuropathy. With its increasing global prevalence, especially in developing countries like Bangladesh, T2DM poses substantial public health challenges.
Management of T2DM requires a combination of lifestyle modifications and pharmacotherapy to achieve and maintain glycemic control. Dipeptidyl peptidase-4 (DPP-4) inhibitors, a class of oral antidiabetic agents, enhance the incretin system, thereby increasing insulin secretion and decreasing glucagon release in a glucose-dependent manner. Omarigliptin, a novel, once-weekly DPP-4 inhibitor, has demonstrated efficacy and safety in clinical trials, but its real-world effectiveness and safety profile, particularly in diverse populations, remain underexplored.
Study Objectives The primary objective of this study is to evaluate the real-world efficacy and safety of omarigliptin in managing newly diagnosed T2DM patients in Bangladesh. Specific objectives include assessing glycemic control (measured by HbA1c levels), monitoring adverse events, analyzing changes in fasting plasma glucose (FPG), postprandial glucose (PPG), and other laboratory parameters, and comparing outcomes with other antidiabetic agents.
Methodology
Study Design:
This is an observational, real-world study conducted over 12 months at the Department of Endocrinology, BIRDEM General Hospital, Dhaka, Bangladesh. The study includes newly diagnosed T2DM patients aged 18 years or older. Participants are divided into two groups: those receiving omarigliptin and those receiving other antidiabetic agents.
Study Population:
Participants will be newly diagnosed T2DM patients attending BIRDEM General Hospital. They will be managed with either omarigliptin or other antidiabetic agents, with personalized treatment regimens decided by the attending physician based on clinical conditions.
Data Collection:
Data will be collected through patient interviews, physical examinations, and laboratory tests. All data will be recorded in standardized case record forms (CRFs). Follow-up assessments will occur at 14 days, 3 months, and 6 months post-enrollment.
Study Variables:
Demographic and laboratory variables will be recorded, including age, gender, socio-economic status, BMI, HbA1c, fasting blood glucose, postprandial glucose, lipid profile, serum creatinine, electrolytes, and liver enzymes. Adverse events will also be tracked and categorized.
Study Procedure:
Participants will receive personalized antidiabetic treatment, including lifestyle modifications and dietary recommendations. The treatment regimen, including the use of omarigliptin, will be determined by the attending physician.
Follow-Up Assessments:
Follow-up assessments will occur at 14 days, 3 months, and 6 months post-enrollment. During these follow-up visits, the following parameters will be checked:
- 14 Days:
- Review of treatment adherence and any immediate side effects
- Physical examination
- Fasting plasma glucose (FPG) levels
- Recording any adverse events (AEs)
- 3 Months:
- Physical examination
- HbA1c levels
- Fasting plasma glucose (FPG) levels
- Postprandial glucose (PPG) levels
- Lipid profile (total cholesterol, LDL, HDL, triglycerides)
- Serum creatinine
- Electrolytes
- Liver enzymes (ALT)
- Recording any adverse events (AEs)
- 6 Months:
- Comprehensive physical examination
- HbA1c levels
- Fasting plasma glucose (FPG) levels
- Postprandial glucose (PPG) levels
- Lipid profile (total cholesterol, LDL, HDL, triglycerides)
- Serum creatinine
- Electrolytes
- Liver enzymes (ALT)
- Monitoring for serious adverse events (SAEs)
- Final recording of adverse events (AEs)
Adverse Event Monitoring:
Adverse events (AEs) and serious adverse events (SAEs) will be monitored throughout the study. Participants will record any side effects in a treatment diary and contact the study team as needed. AEs include any unfavorable medical occurrences, while SAEs involve life-threatening conditions, hospitalization, or significant disability.
Data Analysis:
Data will be analyzed using SPSS Version 23. Descriptive statistics will summarize patient characteristics. Paired t-tests will analyze changes in laboratory parameters. Comparisons between groups will be made using Student's t-tests and chi-square tests. Statistical significance is set at p < 0.05. Regression analysis will identify predictors of treatment response.
Ethical Considerations:
The study will adhere to the Declaration of Helsinki and relevant local guidelines. Ethical approval will be obtained from the Institutional Review Board (IRB) of BIRDEM. Written informed consent will be obtained from all participants before enrollment.
Expected Outcomes:
The study aims to provide real-world evidence on the efficacy and safety of omarigliptin in a typical clinical setting. By comparing outcomes with other antidiabetic agents, the study will help elucidate the relative benefits and risks of omarigliptin, aiding healthcare providers in making informed treatment decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Omarigliptin | Experimental | Drug: OmarigliptinArm A will include patients receiving omarigliptin. However, the decision to initiate omarigliptin will be at the treating physician's discretion. The dose of omarigliptin will be 12.5 mg or 25 mg, oral tablet, once weekly decided by the respective physician. |
| Sulphonylureas | Active comparator | Drug: SulphonylureasThis Arm will include patients receiving Sulphonylureas (Gliclazide/ Glipizide/ Glimepiride/ Tolbutamide) according to the physician's choice. |
| Metformin | Active comparator | Drug: MetforminThis Arm will include patients receiving Metformin according to the physician's choice. |
| DPP-4i | Active comparator | Drug: Other DPP4-iThis Arm will include patients receiving DPP-4i other than sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin etc. |
| Thiazolidinediones | Active comparator | Drug: ThiazolidinedionesThis Arm will include patients receiving Thiazolidinediones (Glitazones, pioglitazone, rosiglitazones) |
| Alpha-Glucosidase Inhibitor | Active comparator | Drug: Alpha-Glucosidase InhibitorThis Arm will include patients receiving Alpha-Glucosidase Inhibitor (Acarbose, Miglitol, etc.) |
| Glucagon-Like Peptide-1 | Active comparator | Drug: Glucagon-Like Peptide-1This Arm will include patients receiving Glucagon-Like Peptide-1 |
| Receptor Agonists (GLP1RA) | Active comparator | Drug: Receptor Agonists (GLP1RA)This Arm will include patients receiving Exenatide, lixisenatide, liraglutide, albiglutide, dulaglutide, and semaglutide etc. |
| SGLT2 inhibitors | Active comparator | Drug: SGLT2 inhibitorsThis Arm will include patients receiving Empagliflozin, Ertugliflozin, Canagliflozin, Dapagliflozin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed T2DM (according to American Diabetic Association, ADA guideline) aged (≥ 18 years) treated with stable doses of antidiabetic medications (with or without omarigliptin) along with standard diet and exercise
- HbA1C ranged ≥7.0% and ≤10.0%
- Stables doses of drug at least 4 weeks
Key exclusion criteria (18 listed)
- Newly diagnosed T2DM who will be prescribed insulin for diabetes management
- History of significant weight loss in past 6 months (more than or equal to 5 kg in 1 month)
- Hypersensitivity to any antidiabetic drug
- Type 1 diabetes, a history of ketoacidosis,
- Active liver disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmarigliptinChemical name: MK-3102 Class: Dipeptidyl peptidase-4 (DPP-4) inhibitor Mechanism of Action: Inhibits DPP-4 enzyme, thereby increasing incretin levels. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Improves β-cell function of the pancreas. Reduces hepatic glucose output. Administration: Once-weekly oral dosing. | Drug | Omarigliptin |
| SulphonylureasChemical Name: Sulphonylureas Class: Sulphonylureas Mechanism of Action: Stimulates insulin release from pancreatic beta cells. Enhances the sensitivity of beta cells to glucose. Reduces hepatic glucose production. Increases peripheral glucose uptake and utilization. Administration: Typically administered once or twice daily, depending on the specific medication and patient needs. | Drug | Sulphonylureas |
| MetforminChemical Name: Metformin Class: Biguanide Mechanism of Action: Decreases hepatic glucose production. Improves insulin sensitivity in peripheral tissues. Enhances peripheral glucose uptake and utilization. Reduces intestinal absorption of glucose. Administration: Administered orally, usually once or twice daily with meals. | Drug | Metformin |
| Other DPP4-iChemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Mechanism of Action: Inhibits DPP-4 enzyme, thereby increasing incretin levels. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Improves β-cell function of the pancreas. Reduces hepatic glucose output. Administration: Typically administered orally once daily. Dosage may vary depending on the specific medication and patient needs. | Drug | DPP-4i |
| ThiazolidinedionesChemical Name: Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone) Class: Thiazolidinediones (TZDs) Mechanism of Action: Activates peroxisome proliferator-activated receptor-gamma (PPAR-γ) in adipose tissue, muscle, and liver. Increases insulin sensitivity in peripheral tissues. Enhances glucose uptake and utilization in muscle and adipose tissue. Reduces hepatic glucose production. Administration: Administered orally, typically once daily. Dosage may vary based on the specific medication and patient response. | Drug | Thiazolidinediones |
| Alpha-Glucosidase InhibitorChemical Name: Alpha-Glucosidase Inhibitors (e.g., Acarbose, Miglitol) Class: Alpha-Glucosidase Inhibitors Mechanism of Action: Inhibits alpha-glucosidase enzymes in the small intestine. Delays the breakdown and absorption of complex carbohydrates. Reduces postprandial blood glucose levels. Administration: Administered orally, typically taken with the first bite of each main meal. Dosage may vary based on the specific medication and patient response. | Drug | Alpha-Glucosidase Inhibitor |
| Glucagon-Like Peptide-1Chemical Name: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: GLP-1 Receptor Agonists Mechanism of Action: Mimics the action of endogenous GLP-1. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Slows gastric emptying. Promotes satiety and reduces food intake. Improves β-cell function of the pancreas. Administration: Administered via subcutaneous injection, with frequency varying from twice daily to once weekly, depending on the specific medication. | Drug | Glucagon-Like Peptide-1 |
| Receptor Agonists (GLP1RA)Chemical Name: GLP-1 Receptor Agonists (GLP1RA) (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: Glucagon-Like Peptide-1 Receptor Agonists Mechanism of Action: Activates GLP-1 receptors. Enhances glucose-dependent insulin secretion. Suppresses glucagon secretion. Slows gastric emptying. Promotes satiety and reduces food intake. Improves β-cell function of the pancreas. Administration: Administered via subcutaneous injection, with frequency varying from twice daily to once weekly, depending on the specific medication. | Drug | Receptor Agonists (GLP1RA) |
| SGLT2 inhibitorsChemical Name: Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors (e.g., Canagliflozin, Dapagliflozin, Empagliflozin, Ertugliflozin) Class: SGLT2 Inhibitors Mechanism of Action: Inhibits SGLT2 in the proximal renal tubules. Reduces reabsorption of filtered glucose from the renal tubules. Increases urinary glucose excretion. Lowers blood glucose levels independently of insulin. Administration: Administered orally, typically once daily. Dosage may vary based on the specific medication and patient response. | Drug | SGLT2 inhibitors |
Primary outcome
Glycemic Control as Measured by HbA1c Levels
Time frame: Baseline assessment. Follow-up visits at 14 days, 3 months, and 6 months post-enrollment.
Evaluation of the efficacy of omarigliptin in managing glycemic control among newly diagnosed Type 2 Diabetes Mellitus (T2DM) patients in a real-world clinical setting.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faria Afsana, MD principal investigator
Associate Professor, BIRDEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omarigliptin, Sulphonylureas and Metformin in people with Type2diabetes, run by Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamanna Tabassum, MBBS, MPH (8801755383138, tamanna.tabassum@pirdc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control as Measured by HbA1c Levels (time frame: Baseline assessment. Follow-up visits at 14 days, 3 months, and 6 months post-enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.