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

Daewoong Pharmaceutical Co. LTD.1 site in 1 country240 target enrollmentMarch 17, 2023

Overview

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

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

Registry

clinicaltrials.gov

Start Date

March 17, 2023

End Date

September 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

•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.

•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.