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

NCT ID: NCT03851432

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Janagliflozin 25 mg 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)

Group Type: EXPERIMENTAL

Janagliflozin plus metformin

Intervention Type: DRUG

Janagliflozin: Tablets, Oral, 25 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

Janagliflozin 50 mg plus metformin

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)

Group Type: EXPERIMENTAL

Janagliflozin plus metformin

Intervention Type: DRUG

Janagliflozin: Tablets, Oral, 50 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

Placebo/Janagliflozin plus metformin

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.

Group Type: PLACEBO_COMPARATOR

Placebo plus metformin

Intervention Type: DEVICE

Placebo: Tablets, Oral, 25/50 mg, Once daily, 24 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

Interventions

Janagliflozin plus metformin

Janagliflozin: Tablets, Oral, 25 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

Intervention Type: DRUG

Janagliflozin plus metformin

Janagliflozin: Tablets, Oral, 50 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

Intervention Type: DRUG

Placebo plus metformin

Placebo: Tablets, Oral, 25/50 mg, Once daily, 24 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sihuan Pharmaceutical Holdings Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Linong Ji

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Leili Gao, Doctor

Role: CONTACT

plum_jj@sina.com

00861088325578 ext. 00861088325578

Linong Ji, Doctor

Role: CONTACT

plum_jj@sina.com

00861088325578 ext. 00861088325578

Facility Contacts

Linong Ji

Role: primary

plum_jj@sina.com

00861088325578 ext. 00861088325578

Other Identifiers

5695-DIA-3002

Identifier Type: -

Identifier Source: org_study_id