Study of Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes With Different Antidiabetic Therapy
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.
Timeline
- Start
- 2018-10-01
- Primary completion
- 2019-12-20
- Completion
- 2019-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Comparator | Insulin aspart30 | Unknown | 0.3 iu/kg | Subcutaneous |
| Comparator | Insulin aspart30 | Unknown | 0.5 iu/kg | Subcutaneous |
| Subject | Metformin | Small molecule | 0.5 g | Oral |
| Subject | SAXAGLIPTIN ANHYDROUS | Small molecule | 5 mg | Oral |