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.
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.
History of pancreatic disease,
History of medullary thyroid carcinoma
Lipase level > 3 times above normal,
Creatinine clearance ≤ 30 mL/min/1.73m2,
Parallel
Liraglutide
DrugPatients 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
DrugIndividuals 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.
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%
the proportion of patients with hypoglycemia
the proportion of patients with hypoglycemia
changes in HbA1c
changes in HbA1c
changes from baseline in FPG(mmol/L)
changes from baseline in FPG(mmol/L)
changes in body weight ( kilograms)
changes in body weight( kilograms)
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