Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD)

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Liraglutide

Criteria

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