The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: DWP16001 Amg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04654390

DW_DWP16001303

Details and patient eligibility

About

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

Enrollment: 270 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 19 to 80 years
2. Subjects with 7% ≤ HbA1c ≤ 11% at Screening
3. Subjects with BMI of 20-45 kg/m2

Exclusion criteria

1. Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
2. Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
3. Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
4. eGFR < 60 mL/min/1.73 m2
5. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
6. Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups

DWP16001 Amg, Dapagiflozin Bmg placebo

Experimental group

Description:

Tablets, Orally, Once daily

Treatment:

Drug: DWP16001 Amg

DWP16001 Amg placebo, Dapagliflozin Bmg

Active Comparator group

Description:

Tablets, Orally, Once daily

Treatment:

Drug: DWP16001 Amg