Trials / Unknown
UnknownNCT03239119
The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) and Safety of rE-4 in Subjects With Type 2 Diabetes Mellitus Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 456 (estimated)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rE-4 5 mcg | 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 |
| BIOLOGICAL | rE-4 10 mcg | 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 |
| BIOLOGICAL | Placebo 5 mcg | 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 |
| BIOLOGICAL | Placebo 10 mcg | 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 |
Timeline
- Start date
- 2017-11-30
- Primary completion
- 2018-12-30
- Completion
- 2019-01-15
- First posted
- 2017-08-03
- Last updated
- 2017-08-03
Source: ClinicalTrials.gov record NCT03239119. Inclusion in this directory is not an endorsement.