Type 2 DiabetesPhase 4NCT02503943
Effects of Incretin on the Blood Pressure and Lipid in Patients With Overweight or Obese Diabetes
A Phase 4 study testing "Liraglutide" and "Mitiglinide", "Metformin" and "Mitiglinide" and "Mitiglinide" in people with Type 2 Diabetes and Overweight, run by Third Affiliated Hospital of Third Military Medical University.
Trial summary
Obesity is one of the characteristics of type 2 diabetes mellitus. Most of the obese diabetes patients are combined with dyslipidemia or hypertension. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Type 2 Diabetes, Overweight, Obesity
- What is being tested?
- "Liraglutide" and "Mitiglinide", "Metformin" and "Mitiglinide" and "Mitiglinide"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Sep 2016
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, age between 35-60 years old
- Type 2 diabetes
- 24kg/m²≤BMI≤32kg/m², or WC≥90cm for male and WC≥85cm for female
- Grade 1 hypertension or masked hypertension diagnosed via 24-h ambulatory blood pressure monitoring (daytime blood pressure load 50%≥135/85 mmHg, night time blood pressure load 50%≥125/75 mmHg or 24h blood pressure load 50%≥130/80 mmHg）
Who cannot join
- Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
- Type 1 diabetes.
- Diagnosed moderate to severe sleep apnea syndrome(SAS).
- Grade 2 or Grade 3 hypertension.
- Triglyceride≥5.65mmol/L
- History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
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- Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
- Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- Fertile woman without contraceptives.
- Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- Allergic to or have contraindication to the intervention drugs.
About this study
Official title: What is the Effects of Incretin on the Blood Pressure and Lipid in Overweight or Obese Diabetes Patients With Masked Hypertension: Liraglutide Plus Mitiglinide Comparing Metformin Plus Mitiglinide or Mitiglinide Alone（BLOOD STUDY）
Obesity is one of the characteristics of type 2 diabetes mellitus. Most of the obese diabetes patients are combined with dyslipidemia or hypertension. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Therefore, activation of GLP-1 receptor may become a new comprehensive treatment strategies for improving glucose and lipid metabolism, blood pressure level and cardiovascular complication. But, it is lack of evidence-based medicine proof on the relationship between GLP-1 and blood pressure or serum lipid. So, investigators designed a prospective, randomized, open-label, active control study, and try to evaluate the effects of activator of GLP-1 receptor (liraglutide) on lowering blood pressure, improving vascular function and lipid metabolism in overweight or obese type 2 diabetic patients with masked hypertension.
- Conditions
- Type 2 Diabetes, Overweight, Obesity, Masked Hypertension
- Being tested
- "Liraglutide" and "Mitiglinide", "Metformin" and "Mitiglinide", "Mitiglinide"
- Keywords
- GLP-1, Masked hypertension, Lipid metabolism
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Masked Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Liraglutide" and "Mitiglinide"Drug
"Liraglutide"(1.2mg/d) and "Mitiglinide" (50mg, 3/d)
"Metformin" and "Mitiglinide"Drug
"Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
"Mitiglinide"Drug
"Mitiglinide" (50mg, 3/d)
| Study group | Role | What they receive |
|---|---|---|
| "Liraglutide" and "Mitiglinide" | Experimental | "Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d) Receives: Drug: "Liraglutide" and "Mitiglinide" |
| "Metformin" and "Mitiglinide" | Active comparator | "Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d) Receives: Drug: "Metformin" and "Mitiglinide" |
| "Mitiglinide" | Active comparator | "Mitiglinide"(50mg, 3/d) Receives: Drug: "Mitiglinide" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure change
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L) change
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Secondary outcomes (6)
24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability.
Measured: Baseline，12 weeks,up to 24 weeks
Hemodynamics parameters, including pulse wave velocity(PWV)
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
24-hours urine sodium and microalbumin
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Carotid intima-media thickness(IMT,mm)
Measured: Baseline，12 weeks,up to 24 weeks
Obesity parameters, including waist circumference (WC,cm) and body mass index(BMI, kg/m2)
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Insulin resistance assessed by fasting serum insulin and HOMA-IR, and control rate of diabetes.
Measured: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital of Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinxing Ni, Third Affiliated Hospital of Third Military Medical University
- Investigators
- Zhiming Zhu, MD, PHD, Study chair, The third hospital affiliated to the Third Military Medical University. China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503943
- Sponsor's protocol ID
- BLOOD
- Status last verified
- Jul 2015
- First submitted
- 13 May 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effects of Incretin on the Blood Pressure and Lipid in Overweight or Obese Diabetes Patients With Masked Hypertension: Liraglutide Plus Mitiglinide Comparing Metformin Plus Mitiglinide or Mitiglinide Alone（BLOOD STUDY）
- ClinicalTrials.gov ID
- NCT02503943
- Acronym / sponsor ID
- BLOOD
- Conditions
- Type 2 Diabetes, Overweight, Obesity, Masked Hypertension
- Keywords
- GLP-1, Masked hypertension, Lipid metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital of Third Military Medical UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 21 Jul 2015 (estimated)
- 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.
Obesity is one of the characteristics of type 2 diabetes mellitus. Most of the obese diabetes patients are combined with dyslipidemia or hypertension. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Therefore, activation of GLP-1 receptor may become a new comprehensive treatment strategies for improving glucose and lipid metabolism, blood pressure level and cardiovascular complication. But, it is lack of evidence-based medicine proof on the relationship between GLP-1 and blood pressure or serum lipid. So, investigators designed a prospective, randomized, open-label, active control study, and try to evaluate the effects of activator of GLP-1 receptor (liraglutide) on lowering blood pressure, improving vascular function and lipid metabolism in overweight or obese type 2 diabetic patients with masked hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Liraglutide" and "Mitiglinide" | Experimental | Drug: "Liraglutide" and "Mitiglinide""Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d) |
| "Metformin" and "Mitiglinide" | Active comparator | Drug: "Metformin" and "Mitiglinide""Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d) |
| "Mitiglinide" | Active comparator | Drug: "Mitiglinide""Mitiglinide"(50mg, 3/d) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, age between 35-60 years old
- Type 2 diabetes
- 24kg/m²≤BMI≤32kg/m², or WC≥90cm for male and WC≥85cm for female
- Grade 1 hypertension or masked hypertension diagnosed via 24-h ambulatory blood pressure monitoring (daytime blood pressure load 50%≥135/85 mmHg, night time blood pressure load 50%≥125/75 mmHg or 24h blood pressure load 50%≥130/80 mmHg）
Key exclusion criteria (13 listed)
- Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
- Type 1 diabetes.
- Diagnosed moderate to severe sleep apnea syndrome(SAS).
- Grade 2 or Grade 3 hypertension.
- Triglyceride≥5.65mmol/L
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 |
|---|---|---|
| "Liraglutide" and "Mitiglinide""Liraglutide"(1.2mg/d) and "Mitiglinide" (50mg, 3/d) | Drug | "Liraglutide" and "Mitiglinide" |
| "Metformin" and "Mitiglinide""Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d) | Drug | "Metformin" and "Mitiglinide" |
| "Mitiglinide""Mitiglinide" (50mg, 3/d) | Drug | "Mitiglinide" |
Primary outcome
Blood Pressure change
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L) change
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
6 secondary outcomes
24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability.
Time frame: Baseline，12 weeks,up to 24 weeks
Hemodynamics parameters, including pulse wave velocity(PWV)
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
24-hours urine sodium and microalbumin
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Carotid intima-media thickness(IMT,mm)
Time frame: Baseline，12 weeks,up to 24 weeks
Obesity parameters, including waist circumference (WC,cm) and body mass index(BMI, kg/m2)
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Insulin resistance assessed by fasting serum insulin and HOMA-IR, and control rate of diabetes.
Time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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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.
Zhiming Zhu, MD, PHD study chair
The third hospital affiliated to the Third Military Medical University. China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing "Liraglutide" and "Mitiglinide", "Metformin" and "Mitiglinide" and "Mitiglinide" in people with Type 2 Diabetes and Overweight, run by Third Affiliated Hospital of Third Military Medical University.
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 4 inclusion and 13 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 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Blood Pressure change (time frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks). The study lists 2 primary outcomes in all. 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 21 Jul 2015.