NCT03851432

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
390

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

February 20, 2019

Last Update Submit

July 14, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Change in HbA1c From Baseline to Week 52

    Baseline and Week 52

  • Percentage of Patients With HbA1c <7% at Week 24 (Core period) and Week 52 (Extension period)

    Week 24 and week 52

  • Percentage of Patients With HbA1c <6.5% at Week 24 (Core period) and Week 52 (Extension period)

    Baseline, Week 24 and Week 52

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 (Core period) and Week 52 (Extension period)

    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)

    Baseline, Week 24 and Week 52

  • +7 more secondary outcomes

Study Arms (3)

Janagliflozin 25 mg plus metformin

EXPERIMENTAL

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)

Drug: Janagliflozin plus metformin

Janagliflozin 50 mg plus metformin

EXPERIMENTAL

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)

Drug: Janagliflozin plus metformin

Placebo/Janagliflozin plus metformin

PLACEBO COMPARATOR

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.

Device: Placebo plus metformin

Interventions

Janagliflozin plus metforminDRUG

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 25 mg plus metformin
Placebo plus metforminDEVICE

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.

Placebo/Janagliflozin plus metformin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linong Ji

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

janagliflozinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Leili Gao, Doctor

CONTACT

00861088325578plum_jj@sina.com

Linong Ji, Doctor

CONTACT

00861088325578plum_jj@sina.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

June 30, 2019

Primary Completion

April 30, 2020

Study Completion

December 31, 2021

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

CN(1)