Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
Open-labelled, Randomized, Active-controlled, Parallel-arm, Single-center Study on Effect of Sitagliptin on T2DM Patients on Treatment With Metformin and Insulin
1 other identifier
interventional
440
1 country
1
Brief Summary
The purpose of the study is to determine the efficacy and safety of sitaglipin in the treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using metformin and insulin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Feb 2012
Typical duration for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2011
CompletedFirst Posted
Study publicly available on registry
April 26, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 30, 2014
May 1, 2014
2.2 years
April 23, 2011
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in HbA1c from baseline
To confirm the efficacy of metformin+ insulin+ sitagliptin in controlling glycemia with respect to change from baseline in HbA1c after 24 weeks of administration. This will be accomplished by comparing the difference in change from baseline in HbA1c after 24 weeks of administration, compared with metformin+insulin+glimepiride to a non-inferiority limit of 0.3% , and if non-inferiority is proven, to a superiority limit of 0%.
six months
Secondary Outcomes (7)
Change in total daily dose (TDD) of insulin
6 months
Episodes of hypoglycemia
6 months
Proportion of patients with HbA1c reduction
6 months
change in weight and BMI
6 months
Change in both HbA1c and TDD
6 months
- +2 more secondary outcomes
Study Arms (2)
Sitagliptin along with metformin and insulin
EXPERIMENTALGlimepiride as an active comparator to Sitagliptin
ACTIVE COMPARATORInterventions
100 mg once daily for 6 months
1 mg/2 mg/3 mg once daily
\>=1000 mg twice daily
TDD \> 10 IU once/twice daily
Eligibility Criteria
You may qualify if:
- T2DM patients on metformin and biphasic or basal regimens of insulin
- HbA1c ≥7.3% to ≤8.5%
- Age: 25 to 60 yrs
- Insulin TDD \> 10 IU
You may not qualify if:
- Use of acarbose, pioglitazone or short-acting insulin analogues at time of run-in phase
- History of type 1 diabetes mellitus
- Creatinine clearance ≤50 mL/min
- Chronic liver \& kidney diseases, SGOT/PT≥2.5x upper limit of normal, uncontrolled thyroid disorders , cardiac failure, hemochromatosis, autoimmune disorders, corticosteroid intake.
- BMI \>40 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jothydev's Diabetes and Research Center
Thiruvananthapuram, Kerala, 695032, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jothydev Kesavadev, MD
Jothydev's Diabetes and Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2011
First Posted
April 26, 2011
Study Start
February 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 30, 2014
Record last verified: 2014-05