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

Sihuan Pharmaceutical Group

Status and phase: Unknown; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Placebo plus metformin; Drug: Janagliflozin plus metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03851432

5695-DIA-3002

Details and patient eligibility

About

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.

Full 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 (25 mg and 50 mg) compared to placebo, all in combination with Metformin, in patients diagnosed with T2DM who are not achieving an adequate response from Metformin monotherapy. Approximately 390 patients with inadequate glycemic control with Metformin monotherapy will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg , both in combination with Metformin , for 52 weeks, or receive 24 weeks of double-blind treatment with placebo in combination with Metformin followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg, both in combination with Metformin. During the treatment, if a patient's glycemic level remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with Linagliptin (rescue therapy) consistent with local prescribing information.

Enrollment: 390 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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390 participants in 3 patient groups, including a placebo group

Janagliflozin 25 mg plus metformin

Experimental group

Description:

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)

Treatment:

Drug: Janagliflozin plus metformin

Drug: Janagliflozin plus metformin

Janagliflozin 50 mg plus metformin

Experimental group

Description:

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)

Treatment:

Drug: Janagliflozin plus metformin

Drug: Janagliflozin plus metformin

Placebo/Janagliflozin plus metformin

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo plus metformin