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

Type2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03239119
• Other study ID #: rE-4201706/PRO
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 1, 2017
• Last updated: August 2, 2017
• Start date: November 30, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: July 2017
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: linong Ji, Ph.D
• Phone: +86-01088325578
• Email: jiln[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 456
• Est. completion date: January 15, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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, a-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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30
Secondary	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
Secondary	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