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

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: Placebo; Drug: DWP16001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04014023

DWP16001201

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

196 participants in 4 patient groups, including a placebo group

DWP16001 Amg

Experimental group

Description:

DWP16001 Amg, Tablets, Orally, Once daily

Treatment:

Drug: DWP16001

Drug: Placebo

DWP16001 Bmg

Experimental group

Description:

DWP16001 Bmg, Tablets, Orally, Once daily

Treatment:

Drug: DWP16001

Drug: Placebo

DWP16001 Cmg

Experimental group

Description:

DWP16001 Cmg, Tablets, Orally, Once daily

Treatment:

Drug: DWP16001

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo, Tablets, Orally, Once daily

Treatment:

Drug: Placebo