Study of Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes With Different Antidiabetic Therapy

• Status: Unknown status
• Trial end date: 2019-03-01

Summary

Study Hypothesis：Compared with premixed insulin, triple oral combination therapy has similar hypoglycemic effect, better weight control and lower incidence of hypoglycemia.

Main objective: Comparing whether the hypoglycemic efficacy of the triple oral combination therapy is not inferior than that of the premixed insulin in the treatment of newly-diagnosed type 2 diabetes.

Secondary objective: Comparing the effects on body weight and the risk of inducing hypoglycemia between triple oral combination therapy and premixed insulin, and exploring the effects of these two therapies on weight control and safety.

Primary Study Endpoint: The absolute change in baseline of HAb1c after 12 weeks.

Secondary Study Endpoint: fasting blood glucose, 2-hour postprandial blood glucose, fasting C-peptide, 2-hour postprandial C-peptide, body weight, proportion of patients with hypoglycemia, etc.

• Phase: Phase 4

Details

• Lead Sponsor: Zhujiang Hospital
• Collaborators: Dongguan Kanghua Hospital; First People's Hospital, Shunde China; Peking University Shenzhen Hospital; Shenzhen Sixth People's Hospital; The Fifth Affiliated Hospital of Zunyi Medical College; the Fifth Affiliated Hospital of Zunyi Medical University; The First Affiliated Hospital of Guangdong Pharmaceutical University; The Sixth Affiliated Hospital of Guangzhou Medical University; Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Dapagliflozin; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin, Globin Zinc; Metformin; Saxagliptin