search
Back to results

Janagliflozin Treat T2DM Monotherapy

Primary Purpose

Diabetes Type 2

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Janagliflozin 25mg
Janagliflozin 50mg
Placebo/Janagliflozin
Sponsored by
Sihuan Pharmaceutical Holdings Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Linong JiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Janagliflozin 25mg

Janagliflozin 50mg

Placebo/Janagliflozin

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in HbA1c From Baseline to Week 52
To compare the mean change in HbA1c from baseline to week 52 between groups
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
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
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
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
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
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
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
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.
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
Change in β-cell Function From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in β-cell function from Baseline to Week 24 (core period) and Week 52 (extension period) between groups.
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

Full Information

First Posted
January 17, 2019
Last Updated
July 14, 2020
Sponsor
Sihuan Pharmaceutical Holdings Group Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03811548
Brief Title
Janagliflozin Treat T2DM Monotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sihuan Pharmaceutical Holdings Group Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
442 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Janagliflozin 25mg
Arm Type
Experimental
Arm Description
Each patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)
Arm Title
Janagliflozin 50mg
Arm Type
Experimental
Arm Description
Each patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)
Arm Title
Placebo/Janagliflozin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Janagliflozin 25mg
Other Intervention Name(s)
Placebo 50mg
Intervention Description
Tablets, Oral, 25 mg, Tablets, Oral, 50 mg
Intervention Type
Drug
Intervention Name(s)
Janagliflozin 50mg
Other Intervention Name(s)
Placebo 25mg
Intervention Description
Tablets, Oral, 25 mg, Once daily, 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo/Janagliflozin
Intervention Description
Tablets, Oral, 25 mg, Once daily, 52 weeks
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Week 24
Description
To examine whether the mean change in HbA1c from baseline to week 24 with Janagliflozin is superiority (superiority margin of 0.5%) to placebo
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Week 52
Description
To compare the mean change in HbA1c from baseline to week 52 between groups
Time Frame
Baseline and Week 52
Title
Percentage of Patients With HbA1c <7% at Week 24 (Core period) and week 52
Description
To compare the percentage of patients with HbA1c <7% at week 24 (core period) and week 52 (extension period) between groups
Time Frame
Baseline, Week 24 and week 52
Title
Percentage of Patients With HbA1c <6.5% at Week 24 (Core period) and Week 52 (Extension period)
Description
To compare the percentage of patients with HbA1c <6.5% at week 24 (core period) and Week 52 (extension period) between groups
Time Frame
Baseline, Week 24 and Week 52
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Description
To compare the mean change in fasting plasma glucose (FPG) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time Frame
Baseline, Week 24 and Week 52
Title
Change in 2-hour Post-prandial Glucose From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Description
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
Time Frame
Baseline, Week 24 and Week 52
Title
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)
Description
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
Time Frame
Baseline, Week 24 and Week 52
Title
Change in Blood Pressure (systolic blood pressure and diastolic blood pressure) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Description
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
Time Frame
Baseline, Week 24 and Week 52
Title
Change in Body Weight From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Description
To compare the mean change in body weight from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time Frame
Baseline, Week 24 and Week 52
Title
Change in Fasting C-peptide From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Description
To compare the mean change in fasting C-peptide from Baseline to Week 24 (core period) and Week 52 (extension period) between groups.
Time Frame
Baseline, Week 24 and Week 52
Title
Change in Insulin Sensitivity From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Description
To compare the mean change in insulin sensitivity from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Time Frame
Baseline, Week 24 and Week 52
Title
Change in β-cell Function From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Description
To compare the mean change in β-cell function from Baseline to Week 24 (core period) and Week 52 (extension period) between groups.
Time Frame
Baseline, Week 24 and Week 52
Title
Percentage of Patients Who Have Received Rescue Therapy at Week 24 (Core period) and Week 52 (Extension period)
Description
To compare the percentage of patients who have received rescue therapy by Week 24 (core period) and Week 52 (extension period) between groups
Time Frame
Week 24 and Week 52
Other Pre-specified Outcome Measures:
Title
Urinary albumin/creatinine ratio (UACR)
Description
To evaluate Urinary albumin/creatinine ratio in different group
Time Frame
From Baseline to Week 52
Title
Occurrence of adverse events
Description
To evaluate adverse events in different group
Time Frame
From Baseline to Week 52
Title
Occurrence of hypoglycaemic episodes
Description
To evaluate adverse events in different group
Time Frame
From Baseline to Week 52
Title
Population pharmacokinetics assessment
Description
By compare patients' Minimum Plasma Concentration (on week 2, 4, 8, 24)to eveluate Janagliflozin population pharmacokinetics characteristics
Time Frame
Baseline, Week 2, Week4, Week8, Week24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leili Gao, Doctor
Phone
00861088325578
Ext
00861088324516
Email
plum_jj@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linong Ji, Doctor
Phone
00861088325578
Ext
00861088324516
Email
jiln@bjmu.edu.cn
Facility Information:
Facility Name
Linong Ji
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linong Ji
Phone
00861088325578
Ext
00861088325578
Email
plum_jj@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Janagliflozin Treat T2DM Monotherapy

We'll reach out to this number within 24 hrs