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

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

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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