Janagliflozin Treat T2DM Monotherapy

Sihuan Pharmaceutical Group

Status and phase: Unknown; Phase 3

Conditions: Diabetes Type 2

Treatments: Drug: Janagliflozin 25mg; Drug: Janagliflozin 50mg; Drug: Placebo/Janagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03811548

5695-DIA-3001

Details and patient eligibility

About

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.

Full 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 mg and 50 mg) compared to placebo in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 390 patients with inadequate glycemic control with diet and exercise will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg once daily for 52 weeks, or 24 weeks of double-blind treatment with placebo followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg. 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 metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally once daily.

Enrollment: 442 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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442 participants in 3 patient groups

Janagliflozin 25mg

Experimental group

Description:

Each patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)

Treatment:

Drug: Janagliflozin 25mg

Janagliflozin 50mg

Experimental group

Description:

Each patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)

Treatment:

Drug: Janagliflozin 50mg

Placebo/Janagliflozin

Experimental group

Description:

In the core period, each patient will receive placebo once daily for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin once daily until Week 52.

Treatment:

Drug: Placebo/Janagliflozin