The Efficacy and Safety of DWP16001 Compared to Placebo 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04632862

DW_DWP16001301

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: 140 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 ≤ 10% who have been diagnosed with T2DM at least 8 weeks
3. Subjects with BMI of 20-45 kg/m2
4. Subjects who have been on a stable diet and exercise program for at least 8 weeks
5. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

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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140 participants in 2 patient groups, including a placebo group

DWP16001 Amg

Experimental group

Description:

DWP16001 Amg, Tablets, Orally, Once daily

Treatment:

Drug: DWP16001

DWP16001 Amg Placebo

Placebo Comparator group

Description:

DWP16001 Amg Placebo, Tablets, Orally, Once daily

Treatment:

Drug: DWP16001