Comparing Liraglutide and Insulin Glargine for Type 2 Diabetes Management
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
This study is testing if adding a medication called Liraglutide to insulin can help overweight and obese people with uncontrolled type 2 diabetes manage their blood sugar better and avoid weight gain compared to using a different type of insulin alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT03087032 on ClinicalTrials.gov |
What this trial studies
This 24-week, open-label, randomized trial evaluates the efficacy and safety of Liraglutide combined with prandial insulin versus insulin glargine combined with prandial insulin in overweight and obese patients with uncontrolled type 2 diabetes. The study aims to address the challenges of insulin therapy, including weight gain and hypoglycemia, by exploring the potential benefits of adding GLP-1 receptor agonists to insulin regimens. Participants will be monitored for changes in glucose control and weight over the trial period.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults aged 18 to 75 with uncontrolled type 2 diabetes who have not achieved adequate control with oral medications.
Not a fit: Patients with a history of pancreatic disease, significant heart disease, or those with severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for overweight and obese patients with type 2 diabetes, potentially improving their glucose control and reducing weight gain.
How similar studies have performed: Previous studies have shown that combining GLP-1 receptor agonists with insulin can improve outcomes in diabetes management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Xiamen, Fujian
- The first afilliated hospital of Xiamen university — Xiamen, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Xuejun Li, MD — The first afilliated hospital of Xiamen university
- Study coordinator: Changqin Liu, MD
- Email: liuchangqin@xmu.edu.cn
- Phone: +86-133-7698-6106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.