Back to resultsEfficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone (CWP-DIANA-302)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Anagliptin
Sitagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring CWP-0403, Sitagliptin, Metformin, type 2 DM
Eligibility Criteria
Inclusion Criteria:
- Patients who had diagnosed with type 2 DM before 3 months
- Men and women between the age of ≥ 19 and ≤ 75 years
- FPG ≤ 270 mg/dL at screening visit
- Patients who consent to participate in this trial by written Informed Consent Form
Exclusion Criteria:
- Type 1 DM or secondary diabetes
- Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine
- Body mass index < 20 kg/m2 or > 40.0kg/m2
- Subjects who are assessed to be inappropriate for this trial by investigator
Sites / Locations
- Kangbuk Samsung Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sitagliptin
CWP-0403
Arm Description
Sitagliptin 100mg
CWP-0403 100mg
Outcomes
Primary Outcome Measures
The Change in HbA1c from baseline to week24.
Secondary Outcome Measures
The proportion of subjects achieving HbA1c<7% at week24
The proportion of subjects achieving HbA1c<6.5% at week24
The change from baseline to week 24: Fasting plasma glucose
change from baseline to week 24: Fasting serum insulin
change from baseline to week 24 in Fasting serum pro-insulin
change from baseline to week 24 in Fasting serum c-peptide
change from baseline to week 24 in HOMA-β
change from baseline to week 24 in HOMA-IR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01529541
Brief Title
Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone
Acronym
CWP-DIANA-302
Official Title
A Multicenter, Randomized, Double-blind, Double Dummy, Active-controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate the Efficacy and Safety of CWP-0403 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 DM Insufficiently Controlled With Metformin Alone
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
CWP-0403, Sitagliptin, Metformin, type 2 DM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
Sitagliptin 100mg
Arm Title
CWP-0403
Arm Type
Experimental
Arm Description
CWP-0403 100mg
Intervention Type
Drug
Intervention Name(s)
Anagliptin
Intervention Description
Anagliptin 100mg, tablet, twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
Sitagliptin 100mg, tablet, once a day (QD)
Primary Outcome Measure Information:
Title
The Change in HbA1c from baseline to week24.
Time Frame
0wk, 8wk, 16wk, 24wk
Secondary Outcome Measure Information:
Title
The proportion of subjects achieving HbA1c<7% at week24
Time Frame
0wk, 8wk, 16wk, 24wk
Title
The proportion of subjects achieving HbA1c<6.5% at week24
Time Frame
0wk, 8wk, 16wk, 24wk
Title
The change from baseline to week 24: Fasting plasma glucose
Time Frame
0wk, 24wk
Title
change from baseline to week 24: Fasting serum insulin
Time Frame
0wk, 24 wk
Title
change from baseline to week 24 in Fasting serum pro-insulin
Time Frame
0wk, 24wk
Title
change from baseline to week 24 in Fasting serum c-peptide
Time Frame
0wk, 24wk
Title
change from baseline to week 24 in HOMA-β
Time Frame
0wk, 24 wk
Title
change from baseline to week 24 in HOMA-IR
Time Frame
0wk, 24 wk
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who had diagnosed with type 2 DM before 3 months
Men and women between the age of ≥ 19 and ≤ 75 years
FPG ≤ 270 mg/dL at screening visit
Patients who consent to participate in this trial by written Informed Consent Form
Exclusion Criteria:
Type 1 DM or secondary diabetes
Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine
Body mass index < 20 kg/m2 or > 40.0kg/m2
Subjects who are assessed to be inappropriate for this trial by investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone
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