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

NCT05466643 | Recruiting Phase 3

• 1 other identifier: DW_DWP16001305
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline HbA1c

  at Week 24

Study Arms (2)

DWP16001

EXPERIMENTAL

Drug: DWP16001 0.3mg

Placebo

PLACEBO COMPARATOR

Drug: DWP16001 Placebo

Interventions

DWP16001 0.3mg DRUG

1 tablet, Orally, Once daily single dose

DWP16001

DWP16001 Placebo DRUG

1 tablet, Orally, Once daily single dose

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥19 and ≤ 80 years of age at Visit 1 (Screening) in accordance with American Diabetes Association (ADA) guidelines
• Patients who had received a stable dose of Drug A for at least 8 weeks prior to Visit 2 (Run-in vis it).
• 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).
• Patients with FPG of \<270 mg/dL at Visit 1 (Screening) (FPG result at Visit 1 will use local laboratory results)
• Body Mass Index (BMI) 18.0-40.0 kg/m2.

You may not qualify if:

• Patients with type 1 diabetes mellitus (T1DM), congenital diabetes mellitus (DM), or secondary diabetes as follows:
• Diabetes caused by Cushing's syndrome and acromegaly.
• 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.
• 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).
• 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).
• Patients receiving SGLT2 inhibitors, GLP-analogues, thiazolidinediones, or sulfonylureas (at Screening and Run in).
• At Visit 1 (Screening), patients with a history of the following:
• 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.
• Patients with a history of diabetic ketoacidosis or coma from hyperosmolar hyperglycemic syndrome within 24 weeks.
• Patients with a history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, within 3 months prior to Screening.
• 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).
• 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.
• Patients with pituitary insufficiency or adrenal insufficiency.
• Patients with pulmonary embolism, severe pulmonary dysfunction, or who are susceptible to be accompanied by hypoxemia at Screening.
• Patients who are on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Related Publications (1)

• Hong JH, Min KW, Lee CB, Chamnan P, Sirirak T, Sony K, Sattanon S, Kim HJ, Kim SY, Kim Y, Heo JA, Cho JM, Nah JJ, Park MH, Kim JH. Efficacy and Safety of Enavogliflozin as Add-on in Adults with Type 2 Diabetes Mellitus Inadequately Controlled with Insulin or Insulin with Other Antidiabetic Drugs. Diabetes Metab J. 2025 Dec 15. doi: 10.4093/dmj.2025.0477. Online ahead of print.

  PMID: 41397686 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Enavogliflozin

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Younghee Kim

CONTACT

82-10-5768-9733; 2210285@daewoong.co.kr

Study Design

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

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 20, 2022
• Study Start: March 17, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)