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

C

CSPC Pharmaceutical Group

Status and phase

Unknown
Phase 3

Conditions

Type2 Diabetes Mellitus

Treatments

Biological: rE-4 5 mcg
Biological: rE-4 10 mcg
Biological: Placebo 10 mcg
Biological: Placebo 5 mcg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03239119
rE-4201706/PRO

Details and patient eligibility

About

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

Full 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.

Enrollment

456 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

456 participants in 4 patient groups, including a placebo group

rE-4 5 mcg
Experimental group
Description:
Placebo, then rE-4 5 mcg, then rE-4 5 mcg
Treatment:
Biological: rE-4 5 mcg
rE-4 10 mcg
Experimental group
Description:
Placebo, then rE-4 5 mcg, then rE-4 10 mcg
Treatment:
Biological: rE-4 10 mcg
Placebo 5 mcg
Placebo Comparator group
Description:
Placebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg
Treatment:
Biological: Placebo 5 mcg
Placebo 10 mcg
Placebo Comparator group
Description:
Placebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg
Treatment:
Biological: Placebo 10 mcg

Trial contacts and locations

0

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Central trial contact

linong Ji, Ph.D

Data sourced from clinicaltrials.gov

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