Uncontrolled Type 2 Diabetes MellitusPhase 3NCT04801199
Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus
A Phase 3 study testing CPL-2009-0031 140 mg and Sitagliptin 100mg in people with Uncontrolled Type 2 Diabetes Mellitus, run by Cadila Pharnmaceuticals at 12 sites in India.
Trial summary
This trial is a Phase-III, Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled clinical trial to determine the efficacy, safety, and tolerability of oral CPL-2009-0031 140 mg in comparison with Sitagliptin 100 mg in patients with Uncontrolled Type-2 Diabetes Mellitus… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Uncontrolled Type 2 Diabetes Mellitus
- What is being tested?
- CPL-2009-0031 140 mg and Sitagliptin 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 12 sitesIndia
- Study dates
- 26 Jan 2020to 11 Feb 2021
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adult patient of 18-65 years with uncontrolled type 2 diabetes Mellitus (T2DM).
- Patients with HbA1c ≥ 7 to 10 and those on oral hypoglycemic agents ≤ 2 other than Insulin and Gliptins.
- BMI in the range of 18.5 - 35 kg/m2.
- All patients must be willing to give informed consent and can understand \& complying protocol requirement.
- Patients who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator.
- Documented negative test for human immuno virus (HIV), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV).
Who cannot join
- Those who are on insulin and not ready for wash out of 3 months.
- Those who are on gliptin and not ready for wash out of 3 months.
- Those with a history of severe ketosis, diabetic coma or pre-coma, or type 1 diabetes.
- Those scheduled for or who had undergone surgery.
- Those with a severe infection or serious injury
- Pregnant and lactating women.
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- Hypersensitivity and contraindication to DPP-IV inhibitors or excipients of investigational drug formulation.
- Hypertensive patients with blood pressure ≥160/100 mm of Hg.
- History of ischemic heart disease (as evident from ECG), stroke and/or transient ischemic attack.
- Debilitating neurological or psychiatric disorders
- History or currently consuming abusing drugs or alcohol.
- Serious hepatic or renal impairment (liver dysfunction as evidenced by SGPT/SGOT level of 2.5 X ULN and renal dysfunction as evidenced by creatinine level 2.5 X ULN).
- Patient with abnormal clinical chemistry, hematology or urinalysis results that are considered clinically significant by the investigator or the sponsor.
- Patient has any concurrent illness which, in the opinion of the investigator or coinvestigator, may interfere with treatment or evaluation of safety or completion of this study.
- In the investigator's judgment, the patient is unable to adhere to the treatment regimen, protocol procedures or study requirements.
- Participation in another clinical trial in the past 3 months.
- Patients with history of smoking or currently having smoking habit will not be included in the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Bangalore Diabetes Centre
Bangalore, Karnataka, 560043
S.P. Medical College and A.G. Hospital
Bikaner, Rajasthan, 334001
Apollo Hospital International Ltd
Gandhinagar, 382428
Downtown Hospital
Guwahati, Assam, 781006
Bhandari Clinic & Research Centre
Jaipur, Rajasthan, 302015
Nilratan Sircar Medical College & Hospital
Kolkata, West Bengal, 700014
Life Line Diagnostic Centre cum Nursing Home
Kolkata, West Bengal, 70001
Sanjivini Lung Centre
Lucknow, Uttar Pradesh, 226010,
Dhadiwal Hospital
Nashik, Maharashtra, 422002
A C Subba Reddy Government Medical College and Hospital
Nellore, Andhra Pradesh, 524004
Ashirwad Hospital & Research Centre
Ulhasnagar, Maharashtra, 421004
SSG Hospital
Vadodara, Gujarat, 390001
About this study
Official title: Prospective, Randomized, Double Blind, Parallel Group, Two Arm, Comparative, Multicenter, Clinical Study to Compare Efficacy and Safety of Oral CPL-2009-0031 140 mg of Cadila Pharmaceutical Limited, India Against Innovator Sitagliptin 100 mg in Patients With Uncontrolled Type-2 Diabetes Mellitus (T2DM)
This trial is a Phase-III, Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled clinical trial to determine the efficacy, safety, and tolerability of oral CPL-2009-0031 140 mg in comparison with Sitagliptin 100 mg in patients with Uncontrolled Type-2 Diabetes Mellitus (T2DM).
Read the detailed description
In this phase-III trial, after due consent and completing initial 2-weeks of placebo run-in period with diet, exercise and counseling, eligible patients with uncontrolled T2DM will be randomized in balance to receive either once daily oral CPL-2009-0031 140 mg or Sitagliptin 100 mg.
After completing 12 weeks of study post-randomization for regulatory submission, patients will be instructed for continuation of extension phase of treatment and follow up upto 36 weeks.
HbA1c will be measured at screening, baseline, 12 weeks, 24 weeks and 36 weeks of treatment. While, Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) measurement will be performed every 2 weeks.
The enrolled patients will be monitored for safety (AE and SAE) throughout the study period.
- Conditions
- Uncontrolled Type 2 Diabetes Mellitus
- Being tested
- CPL-2009-0031 140 mg, Sitagliptin 100mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPL-2009-0031 140 mgDrug
Patients will receive OD CPL-2009-0031 140 mg for 36 weeks with or without breakfast with a glass of water.
Sitagliptin 100mgDrug
Patients will receive OD Sitagliptin 100 mg for 36 weeks with or without breakfast with a glass of water.
| Study group | Role | What they receive |
|---|---|---|
| CPL-2009-0031 140 mg | Experimental | Single dose, Oral tablet containing 140 mg of CPL-2009-0031, Once daily for 36-weeks Receives: Drug: CPL-2009-0031 140 mg |
| Sitagliptin 100 mg | Active comparator | Single dose, Oral tablet containing 100 mg of Sitagliptin, Once daily for 36-weeks Receives: Drug: Sitagliptin 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c level
To evaluate HbA1c levels between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg
Measured: Baseline, 12 weeks, 24 weeks and 36 weeks from onset of therapy
Secondary outcomes (5)
Fasting Blood Sugar (FBS) level
To compare Fasting Blood Sugar between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg
Measured: Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy
Postprandial Blood Sugar (PPBS) level
To compare Fasting Blood Sugar between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg
Measured: Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy
Frequency of Serious Adverse Events
Determination of safety and tolerability of CPL-2009-0031 140 mg versus Sitagliptin 100 mg based on Frequency of serious adverse events
Measured: From randomization to end of 12 week, 24 week and 36-weeks therapy
Number of hypoglycemic events
Determine number and severity of hypoglycemic events of CPL-2009-0031 140 mg versus Sitagliptin 100 mg
Measured: From randomization to end of 12 week, 24 week and 36-weeks therapy
Frequency of adverse events
Determine frequency and severity of adverse events of CPL-2009-0031 140 mg versus Sitagliptin 100 mg
Measured: From randomization to end of 12 week, 24 week and 36-weeks therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start26 Jan 2020
- Primary completion13 Jan 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadila Pharnmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India
- Responsible party
- Sponsor
- Investigators
- Anil Avhad, MBBS, Study director, Cadila Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801199
- Sponsor's protocol ID
- CRSC18005
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blind, Parallel Group, Two Arm, Comparative, Multicenter, Clinical Study to Compare Efficacy and Safety of Oral CPL-2009-0031 140 mg of Cadila Pharmaceutical Limited, India Against Innovator Sitagliptin 100 mg in Patients With Uncontrolled Type-2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT04801199
- Acronym / sponsor ID
- CRSC18005
- Conditions
- Uncontrolled Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India
- Study start
- 26 Jan 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 16 Mar 2021 (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.
This trial is a Phase-III, Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled clinical trial to determine the efficacy, safety, and tolerability of oral CPL-2009-0031 140 mg in comparison with Sitagliptin 100 mg in patients with Uncontrolled Type-2 Diabetes Mellitus (T2DM).
Detailed description
In this phase-III trial, after due consent and completing initial 2-weeks of placebo run-in period with diet, exercise and counseling, eligible patients with uncontrolled T2DM will be randomized in balance to receive either once daily oral CPL-2009-0031 140 mg or Sitagliptin 100 mg.
After completing 12 weeks of study post-randomization for regulatory submission, patients will be instructed for continuation of extension phase of treatment and follow up upto 36 weeks.
HbA1c will be measured at screening, baseline, 12 weeks, 24 weeks and 36 weeks of treatment. While, Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) measurement will be performed every 2 weeks.
The enrolled patients will be monitored for safety (AE and SAE) throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled study
| Arm | Type | Receives |
|---|---|---|
| CPL-2009-0031 140 mg | Experimental | Drug: CPL-2009-0031 140 mgSingle dose, Oral tablet containing 140 mg of CPL-2009-0031, Once daily for 36-weeks |
| Sitagliptin 100 mg | Active comparator | Drug: Sitagliptin 100mgSingle dose, Oral tablet containing 100 mg of Sitagliptin, Once daily for 36-weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female adult patient of 18-65 years with uncontrolled type 2 diabetes Mellitus (T2DM).
- Patients with HbA1c ≥ 7 to 10 and those on oral hypoglycemic agents ≤ 2 other than Insulin and Gliptins.
- BMI in the range of 18.5 - 35 kg/m2.
- All patients must be willing to give informed consent and can understand \& complying protocol requirement.
- Patients who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator.
Key exclusion criteria (17 listed)
- Those who are on insulin and not ready for wash out of 3 months.
- Those who are on gliptin and not ready for wash out of 3 months.
- Those with a history of severe ketosis, diabetic coma or pre-coma, or type 1 diabetes.
- Those scheduled for or who had undergone surgery.
- Those with a severe infection or serious injury
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 |
|---|---|---|
| CPL-2009-0031 140 mgPatients will receive OD CPL-2009-0031 140 mg for 36 weeks with or without breakfast with a glass of water. | Drug | CPL-2009-0031 140 mg |
| Sitagliptin 100mgPatients will receive OD Sitagliptin 100 mg for 36 weeks with or without breakfast with a glass of water. | Drug | Sitagliptin 100 mg |
Primary outcome
Change in HbA1c level
Time frame: Baseline, 12 weeks, 24 weeks and 36 weeks from onset of therapy
To evaluate HbA1c levels between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg
5 secondary outcomes
Fasting Blood Sugar (FBS) level
Time frame: Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy
Postprandial Blood Sugar (PPBS) level
Time frame: Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy
Frequency of Serious Adverse Events
Time frame: From randomization to end of 12 week, 24 week and 36-weeks therapy
Number of hypoglycemic events
Time frame: From randomization to end of 12 week, 24 week and 36-weeks therapy
Frequency of adverse events
Time frame: From randomization to end of 12 week, 24 week and 36-weeks therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Clinical trial database uploaded on Clinical Trial Registry of India (CTRI)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Anil Avhad, MBBS study director
Cadila Pharmaceutical Limited
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CPL-2009-0031 140 mg and Sitagliptin 100mg in people with Uncontrolled Type 2 Diabetes Mellitus, run by Cadila Pharnmaceuticals at 12 sites in India.
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 6 inclusion and 17 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: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c level (time frame: Baseline, 12 weeks, 24 weeks and 36 weeks from onset of therapy). 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 17 Aug 2021.