The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
ENHANCE-M
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
1 other identifier
interventional
200
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2020
Shorter than P25 for phase_3
1 active site
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
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedStudy Start
First participant enrolled
November 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2021
CompletedOctober 25, 2022
October 1, 2022
12 months
November 12, 2020
October 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c
at 24 weeks
Study Arms (2)
Study group
EXPERIMENTALDWP16001 A mg, Dapagliflozin placebo
Control group
ACTIVE COMPARATORDWP16001 A mg placebo, Dapagliflozin
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with T2DM aged 19 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daewoong pharmatceutical
Soeul, South Korea
Related Publications (1)
Han KA, Kim YH, Kim DM, Lee BW, Chon S, Sohn TS, Jeong IK, Hong EG, Son JW, Nah JJ, Song HR, Cho SI, Cho SA, Yoon KH. Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial. Diabetes Metab J. 2023 Nov;47(6):796-807. doi: 10.4093/dmj.2022.0315. Epub 2023 Feb 9.
PMID: 36756676DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2020
First Posted
November 18, 2020
Study Start
November 18, 2020
Primary Completion
November 3, 2021
Study Completion
November 3, 2021
Last Updated
October 25, 2022
Record last verified: 2022-10