Janagliflozin Treat T2DM Monotherapy

July 14, 2020 updated by: Sihuan Pharmaceutical Holdings Group Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
442

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Leili Gao, Doctor
  • Phone Number: 00861088324516 00861088325578
  • Email: plum_jj@sina.com

Study Contact Backup

  • Name: Linong Ji, Doctor
  • Phone Number: 00861088324516 00861088325578
  • Email: jiln@bjmu.edu.cn

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Linong Ji

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Janagliflozin 25mg
Each patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)
Drug: Janagliflozin 25mg
Tablets, Oral, 25 mg, Tablets, Oral, 50 mg
Other Names:
  • Placebo 50mg
Experimental: Janagliflozin 50mg
Each patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period)
Drug: Janagliflozin 50mg
Tablets, Oral, 25 mg, Once daily, 52 weeks
Other Names:
  • Placebo 25mg
Experimental: Placebo/Janagliflozin
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.
Drug: Placebo/Janagliflozin
Tablets, Oral, 25 mg, Once daily, 52 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 24
Time Frame: Baseline and 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 52
Time Frame: Baseline and Week 52
To compare the mean change in HbA1c from baseline to week 52 between groups
Baseline and Week 52
Percentage of Patients With HbA1c <7% at Week 24 (Core period) and week 52
Time Frame: Baseline, Week 24 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
Percentage of Patients With HbA1c <6.5% at Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Baseline, Week 24 and Week 52
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
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Baseline, Week 24 and Week 52
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
Change in 2-hour Post-prandial Glucose From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Baseline, Week 24 and Week 52
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
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)
Time Frame: Baseline, Week 24 and Week 52
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
Change in Blood Pressure (systolic blood pressure and diastolic blood pressure) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Baseline, Week 24 and Week 52
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
Change in Body Weight From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Baseline, Week 24 and Week 52
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
Change in Fasting C-peptide From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Baseline, Week 24 and Week 52
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
Change in Insulin Sensitivity From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Baseline, Week 24 and Week 52
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
Change in β-cell Function From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Baseline, Week 24 and Week 52
To compare the mean change in β-cell function from Baseline to Week 24 (core period) and Week 52 (extension period) between groups.
Baseline, Week 24 and Week 52
Percentage of Patients Who Have Received Rescue Therapy at Week 24 (Core period) and Week 52 (Extension period)
Time Frame: Week 24 and Week 52
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary albumin/creatinine ratio (UACR)
Time Frame: From Baseline to Week 52
To evaluate Urinary albumin/creatinine ratio in different group
From Baseline to Week 52
Occurrence of adverse events
Time Frame: From Baseline to Week 52
To evaluate adverse events in different group
From Baseline to Week 52
Occurrence of hypoglycaemic episodes
Time Frame: From Baseline to Week 52
To evaluate adverse events in different group
From Baseline to Week 52
Population pharmacokinetics assessment
Time Frame: Baseline, Week 2, Week4, Week8, Week24
By compare patients' Minimum Plasma Concentration (on week 2, 4, 8, 24)to eveluate Janagliflozin population pharmacokinetics characteristics
Baseline, Week 2, Week4, Week8, Week24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sihuan Pharmaceutical Holdings Group Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5695-DIA-3001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings