Study S000035

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

ClinicalTrials.gov record

Registration

Registration: NCT03239119
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: UNKNOWN
Enrollment: 456
Start: 2017-11-30
Primary completion: 2018-12-30
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions: Type2 Diabetes Mellitus
Interventions: BIOLOGICAL:rE-4 5 mcg; BIOLOGICAL:rE-4 10 mcg; BIOLOGICAL:Placebo 5 mcg; BIOLOGICAL:Placebo 10 mcg
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change in HbA1c from Baseline to Week 30 [Baseline (Day 1) to Week 30]

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