A Study to Investigate the Effect of DWP16001 as add-on Therapy to Drug A in Patients With Type 2 Diabetes Mellitus (ENHANCE-I)

A Multicenter, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 as add-on Therapy to Drug A, With or Without Antihyperglycemic Drugs, in Patients With Type 2 Diabetes Mellitus

A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: DWP16001 0.3mg; Drug: DWP16001 Placebo

Detailed Description

Phase 3 study in patients with T2DM, who have inadequate glycemic control on Drug A alone or Drug A in combination with antihyperglycemic drugs.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Younghee Kim; Phone Number: 82-10-5768-9733; Email: 2210285@daewoong.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients ≥19 and ≤ 80 years of age at Visit 1 (Screening) in accordance with American Diabetes Association (ADA) guidelines
2. Patients who had received a stable dose of Drug A for at least 8 weeks prior to Visit 2 (Run-in vis it).
3. In case of antidiabetic concomitant medications, patients who have maintained up to 2 oral antidiabetic drugs [OADs]) without changing regimen/dose/dosage at least 8 weeks prior to Visit 2 (Run-in visit).
4. Patients with FPG of <270 mg/dL at Visit 1 (Screening) (FPG result at Visit 1 will use local laboratory results)
5. Body Mass Index (BMI) 18.0-40.0 kg/m2.

Exclusion Criteria:

1. Patients with type 1 diabetes mellitus (T1DM), congenital diabetes mellitus (DM), or secondary diabetes as follows:

   1. Diabetes caused by Cushing's syndrome and acromegaly.
   2. Patients with fasting C-peptide <0.70 ng/mL (0.23 nmol/L) are excluded if the Investigator cannot rule out T1DM based on the clinical assessment.
   3. Patients with a history of T1DM or a history of ketoacidosis or patients assessed by the Investigator as possibly having T1DM confirmed with a C-peptide <0.70 ng/mL (0.23 nmol/L).
   4. History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
2. Patients receiving SGLT2 inhibitors, GLP-analogues, thiazolidinediones, or sulfonylureas (at Screening and Run in).

3. At Visit 1 (Screening), patients with a history of the following:

   1. Patients who had experienced severe hypoglycemia within 24 weeks prior to Screening or who had experienced hypoglycemia at least 3 times a week within 8 weeks prior to Screening.
   2. Patients with a history of diabetic ketoacidosis or coma from hyperosmolar hyperglycemic syndrome within 24 weeks.
   3. Patients with a history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, within 3 months prior to Screening.
   4. Patients with New York Heart Association (NYHA) Class III, IV congestive heart failure or arrhythmia requiring treatment. History of dose modification of a treatment for thyroid dysfunction within the past 6 weeks (If patients have been on a stable dose from before enrollment to the study, concomitant administration is allowed. Dose reduction for stable condition is allowed).
   5. Patients who had a surgical operation within 4 weeks (excluding minor surgeries without restriction on food and fluid intake) or who are scheduled to have a significant surgery during the study period.
   6. Patients with pituitary insufficiency or adrenal insufficiency.
   7. Patients with pulmonary embolism, severe pulmonary dysfunction, or who are susceptible to be accompanied by hypoxemia at Screening.
4. Patients who are on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: DWP16001 Placebo; 1 tablet, Orally, Once daily single dose
Experimental: DWP16001	Drug: DWP16001 0.3mg; 1 tablet, Orally, Once daily single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from Baseline HbA1c	at Week 24

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DW_DWP16001305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No