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

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04014023
• Other study ID #: DWP16001201
• Status: Recruiting
• Phase: Phase 2
• Start date: July 10, 2019
• Est. completion date: June 2020

Study information

• Verified date: July 2019
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Choi
• Email: jhchoi413[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: June 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• DWP16001
DWP16001 tablets
• Placebo
DWP16001 placebo-matching tablets

Locations

Country	Name	City	State
Korea, Republic of	Daewoong pharmatceutical	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		at 12 weeks
Secondary	Change from baseline in FPG		at week 4, 8, 12
Secondary	The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline		at week 4, 8, 12