Janagliflozin Treat T2DM Monotherapy

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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 treatment, overall safety and Population pharmacokinetics.

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

Details

• Lead Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.

Criteria

Inclusion Criteria:

• 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 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)