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

July 16, 2019 updated by: Daewoong Pharmaceutical Co. LTD.

A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DWP16001 Amg
DWP16001 Amg, Tablets, Orally, Once daily
Drug: DWP16001
DWP16001 tablets
Drug: Placebo
DWP16001 placebo-matching tablets
EXPERIMENTAL: DWP16001 Bmg
DWP16001 Bmg, Tablets, Orally, Once daily
Drug: DWP16001
DWP16001 tablets
Drug: Placebo
DWP16001 placebo-matching tablets
EXPERIMENTAL: DWP16001 Cmg
DWP16001 Cmg, Tablets, Orally, Once daily
Drug: DWP16001
DWP16001 tablets
Drug: Placebo
DWP16001 placebo-matching tablets
PLACEBO_COMPARATOR: Placebo
Placebo, Tablets, Orally, Once daily
Drug: Placebo
DWP16001 placebo-matching tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c
Time Frame: at 12 weeks
at 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

July 7, 2019

First Submitted That Met QC Criteria

July 7, 2019

First Posted (ACTUAL)

July 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DWP16001201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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