Janagliflozin Treat T2DM Monotherapy

NCT03811548 | Unknown Phase 3 DMC

• 1 other identifier: 5695-DIA-3001
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• 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 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

  Baseline, 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

Other Outcomes (4)

• Urinary albumin/creatinine ratio (UACR)

  From Baseline to Week 52

• Occurrence of adverse events

  From Baseline to Week 52

• Occurrence of hypoglycaemic episodes

  From Baseline to Week 52

Study Arms (3)

Janagliflozin 25mg

EXPERIMENTAL

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

Janagliflozin 50mg

EXPERIMENTAL

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

Placebo/Janagliflozin

EXPERIMENTAL

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

Interventions

Janagliflozin 25mg DRUG

Tablets, Oral, 25 mg, Tablets, Oral, 50 mg

Also known as: Placebo 50mg

Janagliflozin 25mg

Janagliflozin 50mg DRUG

Tablets, Oral, 25 mg, Once daily, 52 weeks

Also known as: Placebo 25mg

Janagliflozin 50mg

Placebo/Janagliflozin DRUG

Tablets, Oral, 25 mg, Once daily, 52 weeks

Placebo/Janagliflozin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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)

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Study Sites (1)

Linong Ji

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

janagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Leili Gao, Doctor

CONTACT

00861088325578; plum_jj@sina.com

Linong Ji, Doctor

CONTACT

00861088325578; jiln@bjmu.edu.cn

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: January 17, 2019
• First Posted: January 22, 2019
• Study Start: May 23, 2019
• Primary Completion: June 24, 2020
• Study Completion: December 31, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

CN (1)