Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of rE-4 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two rE-4 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin, a sulfonylurea or metformin and a sulfonylurea combination) throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rE-4 5 mcg | Experimental | Placebo, then rE-4 5 mcg, then rE-4 5 mcg |
|
| rE-4 10 mcg | Experimental | Placebo, then rE-4 5 mcg, then rE-4 10 mcg |
|
| Placebo 5 mcg | Placebo Comparator | Placebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg |
|
| Placebo 10 mcg | Placebo Comparator | Placebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rE-4 5 mcg | Biological | Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 5 mcg for 26 weeks - All are subcutaneously injected twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from Baseline to Week 30 | Change in HbA1c from Baseline (Day 1) to study termination (Week 30) | Baseline (Day 1) to Week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30 | The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by study termination (Week 30) | Baseline (Day 1) and Week 30 |
| Change in body weight from Baseline to each intermediate visit and Week 30 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| linong Ji, Ph.D | Contact | +86-01088325578 | jiln@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| linong Ji, Ph.D | Peking University People's Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| rE-4 10 mcg | Biological | Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 10 mcg for 26 weeks - All are subcutaneously injected twice daily |
|
|
| Placebo 5 mcg | Biological | Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 5 mcg for 26 weeks - All are subcutaneously injected twice daily |
|
| Placebo 10 mcg | Biological | Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 10 mcg for 26 weeks - All are subcutaneously injected twice daily |
|
Change in body weight (kg) from Baseline to each intermediate visit and Week 30 |
| Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30 |
| Change in FPG from Baseline to each intermediate visit and Week 30 | Change in Fasting Plasma Glucose from Baseline to each intermediate visit and Week 30 | Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30 |
| Change in 7-SMBG from Baseline to Week 16,Week 24 and Week 30 | Change in glucose measurements before and 2h after the start of the morning,midday,and evening meals, and at bedtime from Baseline to Week 16,Week 24 and Week 30 | Baseline, Week 16,Week 24 and Week 30 |