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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Efficacy and Safety of Janagliflozin in Combination With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control With Metformin Alone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03851432
• Other study ID #: 5695-DIA-3002
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Sihuan Pharmaceutical Holdings Group Ltd.
• Contact: Leili Gao, Doctor
• Phone: 00861088325578
• Email: plum_jj[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: December 31, 2021
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.
• 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.

Device:
• 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.

Locations

Country	Name	City	State
China	Linong Ji	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sihuan Pharmaceutical Holdings Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c (HbA1c) From Baseline to Week 24 (Core period)	To examine whether the mean change in HbA1c from Baseline to Week 24 with Janagliflozin is superior to placebo	Baseline and Week 24
Secondary	Change in HbA1c From Baseline to Week 52	To compare the mean change in HbA1c from Baseline to Week 52 between groups	Baseline and Week 52
Secondary	Percentage of Patients With HbA1c <7% at Week 24 (Core period) and Week 52 (Extension period)	To compare the percentage of patients with HbA1c <7% at Week 24 (core period) and Week 52 (extension period) between groups	Week 24 and week 52
Secondary	Percentage of Patients With HbA1c <6.5% at Week 24 (Core period) and Week 52 (Extension period)	To compare the percentage of patients with HbA1c <6.5% at week 24 (core period) and Week 52 (extension period) between groups	Baseline, Week 24 and Week 52
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 (Core period) and Week 52 (Extension period)	To compare the mean change in fasting plasma glucose (FPG) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups	Baseline, Week 24 and Week 52
Secondary	Change in 2-hour Post-prandial Glucose From Baseline to Week 24 (Core period) and Week 52 (Extension period)	To compare the mean change in 2-hour post-prandial glucose from Baseline to Week 24 (core period) and Week 52 (extension period) between groups	Baseline, Week 24 and Week 52
Secondary	Change in Blood Lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) From Baseline to Week 24 (Core period) and Week 52 (Extension period)	To compare the mean change in blood lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups	Baseline, Week 24 and Week 52
Secondary	Change in Blood Pressure (systolic blood pressure and diastolic blood pressure) From Baseline to Week 24 (Core period) and Week 52 (Extension period)	To compare the mean change in blood pressure (systolic blood pressure and diastolic blood pressure) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups	Baseline, Week 24 and Week 52
Secondary	Change in Body Weight From Baseline to Week 24 (Core period) and Week 52 (Extension period)	To compare the mean change in body weight from Baseline to Week 24 (core period) and Week 52 (extension period) between groups	Baseline, Week 24 and Week 52
Secondary	Change in Fasting C-peptide From Baseline to Week 24 (Core period) and Week 52 (Extension period)	To compare the mean change in fasting C-peptide from Baseline to Week 24 (core period) and Week 52 (extension period) between groups	Baseline, Week 24 and Week 52
Secondary	Change in Insulin Sensitivity From Baseline to Week 24 (Core period) and Week 52 (Extension period) by calculation Homeostasis model assessment-insulin resistance	To compare the mean change in insulin sensitivity from Baseline to Week 24 (core period) and Week 52 (extension period) between group by calculation Homeostasis model assessment-insulin resistance	Baseline, Week 24 and Week 52
Secondary	Change in ß-cell Function From Baseline to Week 24 (Core period) and Week 52 (Extension period)	To compare the mean change in ß-cell function from Baseline to Week 24 (core period) and Week 52 (extension period) between groups	Baseline, Week 24 and Week 52
Secondary	Percentage of Patients Who Have Received Rescue Therapy at Week 24 (Core period) and Week 52 (Extension period)	To compare the percentage of patients who have received rescue therapy by Week 24 (core period) and Week 52 (extension period) between groups.	Baseline, Week 24 and Week 52