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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
456
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
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 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
Change in HbA1c from Baseline to Week 30
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
Time frame: Baseline (Day 1) to Week 30
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)
Time frame: Baseline (Day 1) and Week 30
Change in body weight from Baseline to each intermediate visit and Week 30
Change in body weight (kg) from Baseline to each intermediate visit and Week 30
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 16,Week 24 and Week 30
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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