Status:
UNKNOWN
Janagliflozin Treat T2DM Monotherapy
Lead Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd.
Conditions:
Diabetes Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatmen...
Detailed Description
A multicentre, randomized, double-blind, parallel group, placebo-controlled study(24 weeks core period followed by 28 Weeks Extension period), to evaluate the efficacy and safety of Janagliflozin (25 ...
Eligibility Criteria
Inclusion
- All patients must have a diagnosis of T2DM (meet the diagnostic criteria for diabetes issued by the World Health Organization in 1999)
- Patients must have a hemoglobin A1c (HbA1c) level ≥7.5% and ≤11% at screening, and ≥7.0% and ≤10.5% at baseline.
- Drug -naïve (never received anti-diabetic medication or did not receive anti-diabetic medication within 8 weeks before screening).
- 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 :
May 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT03811548
Start Date
May 23 2019
End Date
December 31 2020
Last Update
July 16 2020
Active Locations (1)
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1
Linong Ji
Beijing, Beijing Municipality, China