Status:
UNKNOWN
The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Type2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 randomiz...
Eligibility Criteria
Inclusion
- T2DM
- 7.0% ≤ HbA1c ≤ 11.0% at screening
- FPG ≤13.8 mmol/L
- 19 kg/m2 \< BMI \<35.0 kg/m2 at screening
- All subjects provided written informed consent before participation
Exclusion
- 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
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2019
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT03239119
Start Date
November 30 2017
End Date
January 15 2019
Last Update
August 3 2017
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