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Completed

NCT Number: NCT04632862

The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.

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.

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Key information

Conditions

T2DM (Type 2 Diabetes Mellitus) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Daewoong pharmatceutical

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 19 to 80 years
  • Subjects with 7% ≤ HbA1c ≤ 10% who have been diagnosed with T2DM at least 8 weeks
  • Subjects with BMI of 20-45 kg/m2
  • Subjects who have been on a stable diet and exercise program for at least 8 weeks
  • Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion criteria

  • Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
  • Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
  • Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
  • eGFR < 60 mL/min/1.73 m2
  • 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.
  • Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)

Treatment and study plan

DWP16001

Drug

DWP16001 A mg

Primary outcomes

  1. HbA1c level at Week 24 after administration of the IP

    Time frame: at Week 24

    1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP

Secondary outcomes

  1. HbA1c level at Weeks 6, 12, and 18 after administration of the IP

    Time frame: at weeks 6, 12, and 18

    1.Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP

  2. FPG level at Weeks 6, 12, 18, and 24 after administration of the IP

    Time frame: at weeks 6, 12, 18, and 24

    2.Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP

  3. HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP

    Time frame: at weeks 6, 12, 18, and 24

    3.Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2020
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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