Janagliflozin Treat T2DM Monotherapy

Diabetes Type 2 Clinical Trial

Official title:

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled Study, to Evaluate the Efficacy and Safety of Janagliflozin (25 mg and 50 mg) as Monotherapy in Chinese Patients Diagnosed With T2DM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811548
• Other study ID #: 5695-DIA-3001
• Status: Recruiting
• Phase: Phase 3
• Start date: May 23, 2019
• Est. completion date: December 31, 2020

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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 442
• Est. completion date: December 31, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• Janagliflozin 25mg
Tablets, Oral, 25 mg, Tablets, Oral, 50 mg
• Janagliflozin 50mg
Tablets, Oral, 25 mg, Once daily, 52 weeks
• Placebo/Janagliflozin
Tablets, Oral, 25 mg, Once daily, 52 weeks

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
Other	Urinary albumin/creatinine ratio (UACR)	To evaluate Urinary albumin/creatinine ratio in different group	From Baseline to Week 52
Other	Occurrence of adverse events	To evaluate adverse events in different group	From Baseline to Week 52
Other	Occurrence of hypoglycaemic episodes	To evaluate adverse events in different group	From Baseline to Week 52
Other	Population pharmacokinetics assessment	By compare patients' Minimum Plasma Concentration (on week 2, 4, 8, 24)to eveluate Janagliflozin population pharmacokinetics characteristics	Baseline, Week 2, Week4, Week8, Week24
Primary	Change in HbA1c From Baseline to Week 24	To examine whether the mean change in HbA1c from baseline to week 24 with Janagliflozin is superiority (superiority margin of 0.5%) 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	To compare the percentage of patients with HbA1c <7% at week 24 (core period) and week 52 (extension period) between groups	Baseline, 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)	To compare the mean change in insulin sensitivity from Baseline to Week 24 (core period) and Week 52 (extension period) between groups	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	Week 24 and Week 52