Actively Recruiting
Liraglutide Plus Prandial Insulin Versus Insulin Glargine Plus Prandial Insulin in Overweight or Obese Patients with Uncontrolled Type 2 Diabetes A 24-Week Randomized Controlled Study
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-01-13
164
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Liraglutide combined with prandial insulin therapy compared to insulin glargine combined with prandial insulin therapy in overweight or obese adults with uncontrolled type 2 diabetes. This 24-week, open-label, randomized, multicenter study aims to address the challenges of increasing insulin requirements, weight gain, and hypoglycemia in patients receiving intensive insulin treatment. The trial focuses on whether Liraglutide plus prandial insulin can provide better glucose control without these drawbacks. Participants are randomly assigned to one of two treatment groups. One group receives Liraglutide added to prandial insulin Lispro, starting at 0.6 mg/day and increasing to 1.8 mg/day over two weeks, with insulin doses adjusted every 3 days. The other group receives insulin Glargine added to prandial insulin Lispro, self-injected once daily with titration every 3 days. Both treatments are maintained for the full 24 weeks. During the study, participants undergo regular monitoring of blood sugar levels, insulin dosing, and potential side effects like hypoglycemia and weight changes. The main outcome measured is the proportion of patients achieving an HbA1c level below 7.0% without hypoglycemia or weight gain after 24 weeks. Safety and efficacy data are collected throughout, with participant involvement lasting the full 24-week treatment period.
CONDITIONS
Official Title
Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Body mass index (BMI) greater than 24 and less than 45 kg/m2
- Diagnosed with type 2 diabetes according to World Health Organization criteria (1999)
- Newly diagnosed type 2 diabetes with HbA1c ≥ 9.0% or uncontrolled type 2 diabetes (HbA1c ≥ 7.5%) treated with at least two oral hypoglycemic drugs at sufficient doses, or insulin (excluding basal-bolus therapy), or insulin with oral hypoglycemic drugs
- Signed informed consent
You will not qualify if you...
- History of pancreatic disease
- History of medullary thyroid carcinoma
- Lipase level more than 3 times above normal
- Creatinine clearance ≤ 30 mL/min/1.73m2
- Significant heart disease or stroke within the last 6 months, including myocardial infarction, unstable angina, coronary bypass, percutaneous coronary angioplasty, congestive heart failure (NYHA Class III-IV), or severe ischemic heart disease
- Currently pregnant or preparing for pregnancy
- Any factors considered by researchers to affect participation in the trial
- Unable to cooperate in clinical trials
AI-Screening
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Trial Site Locations
Total: 1 location
1
The first afilliated hospital of Xiamen university
Xiamen, Fujian, China, 361003
Actively Recruiting
Research Team
C
Changqin Liu, MD
X
Xin Zheng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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