Investigating DWP16001 for Type 2 Diabetes Management

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

This study is testing a new medication called DWP16001 to see if it can help people with Type 2 Diabetes better control their blood sugar when their current treatments aren't working well enough.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 19 Years to 80 Years
• Sex: All
• Sponsor: Daewoong Pharmaceutical Co. LTD. (industry)
• Locations: 1 site (Seoul)
• Trial ID: NCT05466643 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the efficacy of DWP16001 as an add-on therapy for patients with Type 2 Diabetes Mellitus (T2DM) who have not achieved adequate glycemic control with Drug A alone or in combination with other antihyperglycemic medications. The study is multicenter, randomized, placebo-controlled, and double-blind, ensuring rigorous assessment of the treatment's effectiveness. Participants will receive either DWP16001 or a placebo while continuing their current diabetes medication regimen. The trial aims to determine if DWP16001 can improve glycemic control in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 to 80 with Type 2 Diabetes Mellitus who have been on a stable dose of Drug A for at least 8 weeks and have not achieved adequate glycemic control.

Not a fit: Patients with Type 1 Diabetes Mellitus or those with certain secondary forms of diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide better glycemic control for patients with Type 2 Diabetes Mellitus who struggle to manage their condition with existing therapies.

How similar studies have performed: Other studies have shown promise in using add-on therapies for diabetes management, suggesting that this approach could be beneficial.

Eligibility criteria

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.

Where this trial is running

Seoul

• Samsung Medical Center — Seoul, Korea, Republic of (RECRUITING)

Study contacts

• Study coordinator: Younghee Kim

Conditions: Type 2 Diabetes Mellitus