Back to resultsSitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea
Primary Purpose
Uncontrolled Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Sitagliptin 100mg
Pioglitazone 30 mg
Sponsored by
About this trial
This is an interventional treatment trial for Uncontrolled Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of type 2 diabetes according to the American Diabetes Association
- Baseline level of 7% ≤ A1C < 11% despite a minimum 6 months period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day (uncontrolled type 2 diabetes)
Exclusion Criteria:
- Acute or chronic diseases of heart, lung, kidney,
- Active or past infectious conditions
- Malignancy
Sites / Locations
- Tehran University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sitagliptin
Pioglitazone
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in mean glycated hemoglobin (A1C) levels by sitagliptin vs. pioglitazone
Secondary Outcome Measures
Full Information
NCT ID
NCT03125694
First Posted
March 22, 2017
Last Updated
April 19, 2017
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03125694
Brief Title
Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea
Official Title
Efficacy, Durability, Safety, and Tolerability of Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea: a 52-week, Randomized, Open-label, Parallel-group, Phase 3 Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study has been designed to investigate the comparative effects of sitagliptin vs. pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on the full-dose of metformin and sulfonylurea
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Title
Pioglitazone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100mg
Intervention Description
Sitagliptin arm took sitagliptin 100 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Pioglitazone 30 mg
Intervention Description
Pioglitazone arm took pioglitazone 30 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks
Primary Outcome Measure Information:
Title
Change from baseline in mean glycated hemoglobin (A1C) levels by sitagliptin vs. pioglitazone
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of type 2 diabetes according to the American Diabetes Association
Baseline level of 7% ≤ A1C < 11% despite a minimum 6 months period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day (uncontrolled type 2 diabetes)
Exclusion Criteria:
Acute or chronic diseases of heart, lung, kidney,
Active or past infectious conditions
Malignancy
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea
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