The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin

NCT05505994 | Active Not Recruiting Phase 3

• 1 other identifier: DW_DWP16001304_CN
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases

Keywords

Dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c

  Change in HbA1c (%) is assessed with the values measured at the central laboratory

  at 24 weeks

Study Arms (2)

Study group

EXPERIMENTAL

DWP16001 A mg, Dapagliflozin placebo

Drug: DWP16001; Drug: Dapagliflozin Placebo

Control group

ACTIVE COMPARATOR

DWP16001 A mg placebo, Dapagliflozin

Drug: Dapagliflozin; Drug: DWP16001 Placebo

Interventions

DWP16001 DRUG

DWP16001 A mg tablet

Also known as: DWP16001 tablet

Study group

Dapagliflozin DRUG

Dapagliflozin tablet

Also known as: Dapagliflozin tablet

Control group

DWP16001 Placebo DRUG

DWP16001 Placebo tablet

Also known as: DWP16001 Placebo tablet

Control group

Dapagliflozin Placebo DRUG

Dapagliflozin Placebo tablet

Also known as: Dapagliflozin Placebo tablet

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with T2DM aged 18 to 80 years
• Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
• Subjects with BMI of 20-45 kg/m2
• Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

You may not qualify if:

• Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
• Diabetic ketoacidosis, diabetic coma or precoma within the past year
• Urinary tract infections or genital infections within
• Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
• eGFR \< 60 mL/min/1.73 m2
• Severe heart failure (NYHA class III/IV)

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, +86, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Interventions

Enavogliflozin; dapagliflozin

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Linong Ji, Dr.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1: Double-blind Part 2: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: September 28, 2022
• Primary Completion: February 26, 2024
• Study Completion: September 1, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

CN (1)