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

Who is this study for? Patients with Type 2 Diabetes Patients, Overweight and Obesity
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The first afilliated hospital of Xiamen university
RECRUITING
Xiamen
Contact Information
Primary
Changqin Liu, MD
liuchangqin@xmu.edu.cn
+86-133-7698-6106
Backup
Xin Zheng, MD
88126386@qq.com
+86-187-0592-9102
Time Frame
Start Date: 2019-01-10
Estimated Completion Date: 2025-02-10
Participants
Target number of participants: 164
Treatments
Experimental: Liraglutide-bolus
'Liraglutide-bolus'(Liraglutide once-daily plus thrice-daily prandial insulin lispro). 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.
Active_comparator: Basal-bolus
'Basal-bolus' (insulin glargine once-daily plus thrice-daily prandial insulin lispro). Patients will receive adding insulin Glargine to prandial insulin Lispro.Dose of insulin will be instructed on a titration schedule, adjusted every 3 days. Patients subcutaneously self-injected once-daily at approximately the same time each day.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Xiamen University

This content was sourced from clinicaltrials.gov