Janagliflozin Treat Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Metformin

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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) inadequately controlled with Metformin alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
• Treatments: Metformin

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)