Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus

Phase 2

• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Interventions: Drug: DWP16001; Drug: Placebo

• Registration Number: NCT04014023
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-07
• Study Start: 2019-07-10
• Study First Posted: 2019-07-10
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18
• Primary Completion: 2020-03
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Patients aged 20 to 80 years
• Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before
• Body Mass Index (BMI) between 20 and 45 kg/㎡
• Patients with 7% ≤ HbA1c ≤ 10% at screening
• Subject who has conducted a stable diet and exercise for at least 8 weeks

Exclusion Criteria

• Type 1 diabetes mellitus or secondary diabetes
• Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis)
• Clinical significantly renal disorders
• Creatinine clearance < 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) < 60mL/min/1.73
• Severe gastrointestinal disorder
• Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)
• History of Acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (NYHA class III/IV), or heart arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP16001 Bmg	DWP16001	DWP16001 Bmg, Tablets, Orally, Once daily
DWP16001 Amg	DWP16001	DWP16001 Amg, Tablets, Orally, Once daily
DWP16001 Cmg	DWP16001	DWP16001 Cmg, Tablets, Orally, Once daily
Placebo	Placebo	Placebo, Tablets, Orally, Once daily
DWP16001 Bmg	Placebo	DWP16001 Bmg, Tablets, Orally, Once daily
DWP16001 Amg	Placebo	DWP16001 Amg, Tablets, Orally, Once daily
DWP16001 Cmg	Placebo	DWP16001 Cmg, Tablets, Orally, Once daily

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c	at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in FPG	at week 4, 8, 12
The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline	at week 4, 8, 12

Trial Locations

Locations (1)

Daewoong pharmatceutical; 🇰🇷 Seoul, Korea, Republic of