The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

Phase 3

• Conditions: Type2 Diabetes Mellitus
• Interventions: Biological: Placebo 5 mcg; Biological: rE-4 5 mcg; Biological: rE-4 10 mcg; Biological: Placebo 10 mcg

• Registration Number: NCT03239119
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief 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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-03
• Last Update Posted: 2017-08-03
• Study Start: 2017-11-30
• Primary Completion: 2018-12-30
• Study Completion: 2019-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

1. T2DM
2. 7.0% ≤ HbA1c ≤ 11.0% at screening
3. FPG ≤13.8 mmol/L
4. 19 kg/m2 < BMI <35.0 kg/m2 at screening
5. All subjects provided written informed consent before participation

Exclusion Criteria

1. T1DM
2. Patients treated previously with Exenatide or GLP-1 similar
3. At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN
4. At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L
5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases
6. Within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period
7. History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones)
8. Patients with severe renal impairment or end-stage renal disease
9. Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit.
10. Use of weight loss drugs within 3 months prior to screening visit
11. Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening.
12. Severe gastrointestinal disease (e.g., gastroparesis)
13. Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
14. Participant who participated in any drug clinical trial within the last 3 months prior to screening visit
15. History of severe hypersensitivity to rExenatide-4 or any product components

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 5 mcg	Placebo 5 mcg	Placebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg
rE-4 5 mcg	rE-4 5 mcg	Placebo, then rE-4 5 mcg, then rE-4 5 mcg
rE-4 10 mcg	rE-4 10 mcg	Placebo, then rE-4 5 mcg, then rE-4 10 mcg
Placebo 10 mcg	Placebo 10 mcg	Placebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from Baseline to Week 30	Baseline (Day 1) to Week 30	Change in HbA1c from Baseline (Day 1) to study termination (Week 30)

Secondary Outcome Measures

Name	Time	Method
The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30	Baseline (Day 1) and Week 30	The number of subjects achieving HbA1c target values of \< 7% and ≤ 6.5% by study termination (Week 30)
Change in body weight 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 body weight (kg) from Baseline to each intermediate visit and Week 30
Change in FPG 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 Fasting Plasma Glucose from Baseline to each intermediate visit and Week 30
Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30	Baseline, 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