Status:
UNKNOWN
Janagliflozin Treat Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Metformin
Lead Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Janagliflozin compared to placebo, both in combination with Metformin, in Chinese patients with type 2 diabetes mellitus (T2DM) inad...
Detailed Description
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study (a 24-week core period followed by a 28-week extension period), to evaluate the efficacy and safety of Janagliflozin (...
Eligibility Criteria
Inclusion
- T2DM Patients with inadequate glycemic control (HbA1c level≥7.0% and ≤10.5% at baseline) on metformin monotherapy.
- Body Mass Index: 18.0\~35.0 kg/m2 (both inclusive)
Exclusion
- History of type 1 diabetes mellitus (T1DM), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly)
- More than 10% change in body weight within the 3 months before screening
- Any laboratory test indicators meet the following standards:
- fasting plasma glucose ≥ 15 mmol/L
- aspartate aminotransferase, alanine aminotransferase levels \> 3 times the upper limit of normal (ULN); total bilirubin \> 1.5 times ULN
- hemoglobin \< 100 g/L
- eGFR \< 60 mL/min/1.73m2
- fasting triglycerides \> 5.64 mmol/L (500 mg/dL)
Key Trial Info
Start Date :
June 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT03851432
Start Date
June 30 2019
End Date
December 31 2021
Last Update
July 16 2020
Active Locations (1)
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1
Linong Ji
Beijing, Beijing Municipality, China