Janagliflozin Treat Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Metformin
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- Linong JiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Janagliflozin 25 mg plus metformin
Janagliflozin 50 mg plus metformin
Placebo/Janagliflozin plus metformin
Each patient will receive 25 mg of Janagliflozin plus metformin for 52 weeks (a 24-week core period followed by a 28-week extension period)
Each patient will receive 50 mg of Janagliflozin plus metformin for 52 weeks (a 24-week core period followed by a 28-week extension period)
In the core period, each patient will receive placebo plus metformin for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin plus metformin until Week 52.