A Phase 4 interventional study of Liraglutide and insulin glargine in Type 2 Diabetes Patients, Overweight and Obesity and Hyperglycaemia (Diabetic), sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by The First Affiliated Hospital of Xiamen University · Phase 4, Interventional, and Treatment
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.
An increasing number of patients with type 2 diabetes are treated with insulin. Patients with diabetes receiving intensive insulin therapy with various combinations of basal and prandial insulin can be caught in a vicious but common cycle, whereby insulin requirements increase over time, and this in turn contributes to weight gain and hypoglycemia and further increases in insulin dosing. At this stage, clinicians observe a practical limit to the efficacy of insulin titration alone on glucose-lowering and often add or continue metformin to reduce insulin resistance. Injectable glucagon-like peptide-1 receptor agonists (GLP-1 RAs), such as liraglutide, are a relatively new addition to our treatment armamentarium. These drugs improve glucose control and insulin sensitivity and contribute to weight loss. Treatment with basal insulin plus GLP-1RAs is well-established in diabetes guidelines and may be as effective as adding prandial insulin therapy. When GLP-1 RAs are started, a preemptive reduction in insulin dosage by 25% to 30% in patients with HbA1c \< 9% may reduce the risk for hypoglycemia. In overweight/obese patients with uncontrolled type 2 diabetes treated with more than three oral antidiabetic drugs (OADs) or high doses of premix insulin, Is basal-prandial insulin therapy the option treatment algorithm? Such an intensification strategy carries risk of increased hypoglycaemia and weight gain, both of which are associated with worse long-term outcomes. There have no randomized, controlled trials to evaluate the efficacy and safety of GLP-1 RAs vs insulin glargine added to prandial insulin in overweight/obese patients with uncontrolled type 2 diabetes. So, the current 24-week, prospective, open-label, randomized, multicenter, parallel group trial will be preformed to assess whether Liraglutide plus prandial insulin therapy was superior to glargine plus prandial insulin therapy in overweight/obese patients with uncontrolled type 2 diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 164 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
'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.
Drug: Liraglutide
'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.
Drug: insulin glargine
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.
Also known as: Victozaa, Liraglutid, Liroglutide, Liraglutidum, Liraglutide Acetate
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.
Also known as: Lantus
the proportion of patients with HbA1c < 7.0% without experiencing hypoglycemia and without weight gain,with a superiority margin of 3%
the net difference in the proportion of patients with HbA1c \< 7.0% without experiencing hypoglycemia and without weight gain is more than 3%
Time frame: 24 weeks
the proportion of patients with hypoglycemia
the proportion of patients with hypoglycemia
Time frame: 24 weeks
changes in HbA1c
changes in HbA1c
Time frame: 24 weeks
changes from baseline in FPG(mmol/L)
changes from baseline in FPG(mmol/L)
Time frame: 24 weeks
changes in body weight ( kilograms)
changes in body weight( kilograms)
Time frame: 24 weeks
changes in prandial insulin dosage （per kilogram）
changes in prandial insulin dosage （per kilogram）
Time frame: 24 weeks
changes in visceral as assessed by dual x-ray absorptiometry (DXA)
changes in visceral as assessed by dual x-ray absorptiometry (DXA)
Time frame: 24 weeks
number of participants with abnormal laboratory values and/or adverse events that are related to treatment
number of participants with abnormal laboratory values and/or adverse events
Time frame: 24 weeks
changes in serum c-peptide level
changes in serum c-peptide level
Time frame: 24 weeks
changes in systolic pressure
changes in systolic pressure
Time frame: 24 weeks
changes in diastolic pressure
changes in diastolic pressure
Time frame: 24 weeks
changes in serum lipid profile
changes in serum lipid profile
Time frame: 24 weeks
Plan to share: Undecided
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The First Affiliated Hospital of Xiamen University