Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD)
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 First Affiliated Hospital of Xiamen University
164 participants
Jan 10, 2019
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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
Interventions
Patients will receive adding Liraglutide to prandial insulin Lispro. The starting liraglutide dose was 0.6mg/day, then 1.2mg/day after 1 week and 1.8mg/day after a further week. The dose was maintained until study completion. Dose of insulin Lispro will be instructed on a titration schedule, adjusted every 3 days.
Individuals randomized to adding insulin Glargine to prandial insulin Lispro will be instructed on a titration schedule, adjusted every 3 days. Patients subcutaneously self-injected once-daily at approximately the same time each day.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03087032