RecruitingPhase 4NCT03087032

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


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

164 participants

Start Date

Jan 10, 2019

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two insulin-based treatment strategies in overweight or obese people with type 2 diabetes that is not well controlled — specifically, whether using a GLP-1 receptor agonist (liraglutide) plus rapid-acting insulin works better than using long-acting insulin (glargine) plus rapid-acting insulin. **You may be eligible if...** - You are between 18 and 75 years old with a BMI between 24 and 45 kg/m² - You have type 2 diabetes that is not well controlled (HbA1c of 9.0% or above if newly diagnosed, or 7.5% or above despite taking at least two oral diabetes medications or current insulin treatment) - You have been diagnosed using standard World Health Organization criteria **You may NOT be eligible if...** - You have a history of pancreatic disease or a specific type of thyroid cancer (medullary thyroid carcinoma) - Your pancreatic enzyme levels (lipase) are more than 3 times above normal - Your kidneys are not functioning well (creatinine clearance at or below 30 mL/min) - You have had a heart attack, stroke, coronary bypass, or severe heart failure in the past 6 months - You are pregnant, trying to become pregnant, or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiraglutide

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.

DRUGinsulin glargine

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)

The first afilliated hospital of Xiamen university

Xiamen, Fujian, China

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NCT03087032


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