Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT03087032

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes Patients, Overweight and Obesity, Hyperglycaemia (Diabetic)

Full registry 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

Treatments and study arms

Liraglutide

Drug

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.

insulin glargine

Drug

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.

Primary outcomes

the proportion of patients with HbA1c < 7.0% without experiencing hypoglycemia and without weight gain,with a superiority margin of 3%24 weeks

the net difference in the proportion of patients with HbA1c \< 7.0% without experiencing hypoglycemia and without weight gain is more than 3%

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The first afilliated hospital of Xiamen university🇨🇳 Xiamen, Fujian, China

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Changqin Liu, MDContact

Email · Call +86-133 7698 6106