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

NCT ID: NCT03239119

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2019-01-15

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.

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rE-4 5 mcg

Placebo, then rE-4 5 mcg, then rE-4 5 mcg

Group Type: EXPERIMENTAL

rE-4 5 mcg

Intervention Type: BIOLOGICAL

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, then rE-4 5 mcg, then rE-4 10 mcg

Group Type: EXPERIMENTAL

rE-4 10 mcg

Intervention Type: BIOLOGICAL

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 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg

Group Type: PLACEBO_COMPARATOR

Placebo 5 mcg

Intervention Type: BIOLOGICAL

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 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg

Group Type: PLACEBO_COMPARATOR

Placebo 10 mcg

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Other Intervention Names

rExenatide-4; rExenatide-4

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

linong Ji, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

linong Ji, Ph.D

Role: CONTACT

jiln@bjmu.edu.cn

+86-01088325578

Other Identifiers

rE-4201706/PRO

Identifier Type: -

Identifier Source: org_study_id