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

NCT03239119 | Unknown Phase 3

• 1 other identifier: rE-4201706/PRO
• Study Type: interventional
• Target: 456
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes Mellitus

Keywords

rE-4; Exenatide; Metformin; Sulfonylurea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30

  Baseline (Day 1) and 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 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 7-SMBG from Baseline to Week 16，Week 24 and Week 30

  Baseline, Week 16，Week 24 and Week 30

Study Arms (4)

rE-4 5 mcg

EXPERIMENTAL

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

Biological: rE-4 5 mcg

rE-4 10 mcg

EXPERIMENTAL

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

Biological: rE-4 10 mcg

Placebo 5 mcg

PLACEBO COMPARATOR

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

Biological: Placebo 5 mcg

Placebo 10 mcg

PLACEBO COMPARATOR

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

Biological: Placebo 10 mcg

Interventions

rE-4 5 mcg 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

Also known as: rExenatide-4

rE-4 5 mcg

rE-4 10 mcg 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

Also known as: rExenatide-4

rE-4 10 mcg

Placebo 5 mcg 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 5 mcg

Placebo 10 mcg 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

Placebo 10 mcg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2DM
• % ≤ HbA1c ≤ 11.0% at screening
• FPG ≤13.8 mmol/L
• kg/m2 \< BMI \<35.0 kg/m2 at screening
• All subjects provided written informed consent before participation

You may not qualify if:

• T1DM
• Patients treated previously with Exenatide or GLP-1 similar
• At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN
• At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L
• Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases
• 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
• History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones)
• Patients with severe renal impairment or end-stage renal disease
• Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit.
• Use of weight loss drugs within 3 months prior to screening visit
• Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening.
• Severe gastrointestinal disease (e.g., gastroparesis)
• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
• Participant who participated in any drug clinical trial within the last 3 months prior to screening visit
• History of severe hypersensitivity to rExenatide-4 or any product components

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Officials

• linong Ji, Ph.D

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

linong Ji, Ph.D

CONTACT

+86-01088325578; jiln@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: November 30, 2017
• Primary Completion: December 30, 2018
• Study Completion: January 15, 2019
• Last Updated: August 3, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share