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

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT03087032
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 10, 2019
Status verified
Jan 2025
Primary completion
Jan 15, 2025
Completion
Feb 10, 2025

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Central Contacts

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