Overweight and Obesity Clinical Trial
— LiraGooDOfficial title:
Efficacy and Safety of Liraglutide-bolus (Liraglutide Plus Prandial Insulin) Versus Glargine-bolus Therapy in Overweight / Obese Patients With Uncontrolled Type 2 Diabetes (LiraGooD)--A Multicenter Randomized Controlled Study
The present 24-week, prospective, open-label, randomized, multicenter, parallel group trial is carried to investigate and evaluate the efficacy and safety of Liraglutide in combination with prandial insulin therapy vs insulin glargine in combination with prandial insulin therapy in overweight / obese patients with uncontrolled type 2 diabetes.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age: 18 - 75 years old. - BMI must be greater than 24 and less than 45 kg/m2 - Patients with type 2 diabetes who met the World Health Organization (who) diagnostic criteria (1999). - Newly diagnosed type 2 diabetic patients with HbA1c = 9.0%;or patients with uncontrolled type 2 diabetes (HbA1c = 7.5% ) who have received at least two types of oral hypoglycemic drugs (the dose of each drug needs to reach the second largest dose or more), or only insulin (excluding basal-bolus insulin therapy), or insulin with oral hypoglycemic drugs. - Signed informed consent. Exclusion Criteria: - History of pancreatic disease, - History of medullary thyroid carcinoma - Lipase level > 3 times above normal, - Creatinine clearance = 30 mL/min/1.73m2, - Evidence in the last 6 months of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty, congestive heart failure (New York Heart Association Functional Classification III-IV), or severe ischemic heart disease. - Preparation for pregnancy or having been in pregnancy - Researchers believe that there are any factors that affect assessing subjects' participation in trial. - Patients unable to cooperate in clinical trials |
Country | Name | City | State |
---|---|---|---|
China | The first afilliated hospital of Xiamen university | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Xiamen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in HbA1c level after 24 weeks,with a noninferiority margin of 0.3% | the net change in glycated hemoglobin level is less than 0.3% | 24 weeks | |
Secondary | changes from baseline in FPG(mmol/L) | changes from baseline in FPG(mmol/L) | 24 weeks | |
Secondary | changes in body weight ( kilograms) | changes in body weight( kilograms) | 24 weeks | |
Secondary | changes in prandial insulin dosage (per kilogram) | changes in prandial insulin dosage (per kilogram) | 24 weeks | |
Secondary | changes in visceral as assessed by dual x-ray absorptiometry (DXA) | changes in visceral as assessed by dual x-ray absorptiometry (DXA) | 24 weeks | |
Secondary | number of participants with abnormal laboratory values and/or adverse events that are related to treatment | number of participants with abnormal laboratory values and/or adverse events | 24 weeks | |
Secondary | changes in abdominal circumference | changes in abdominal circumference | 24 weeks | |
Secondary | changes in waist circumference | changes in waist circumference | 24 weeks | |
Secondary | changes in serum c-peptide level | changes in serum c-peptide level | 24 weeks | |
Secondary | changes in systolic pressure | changes in systolic pressure | 24 weeks | |
Secondary | changes in diastolic pressure | changes in diastolic pressure | 24 weeks | |
Secondary | changes in serum lipid profile | changes in serum lipid profile | 24 weeks |
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