Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
NCT ID: NCT01341717
Last Updated: 2014-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
440 participants
INTERVENTIONAL
2012-02-29
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Addition of sitagliptin to treatment of T2DM patients poorly controlled on insulin +/- metformin has been shown to reduce HbA1c while being generally well-tolerated.
It could be clinically useful to add sitaglipin to treatment regimen of T2DM patients on stable therapy with insulin \& metformin. Apart from glycemic reduction, secondary effects like prevention of weight gain, reduction in insulin dose, improved cardiovascular risk profile, etc. may be expected from addition of sitagliptin to treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sitagliptin along with metformin and insulin
Sitagliptin
100 mg once daily for 6 months
Glimepiride
1 mg/2 mg/3 mg once daily
Metformin
\>=1000 mg twice daily
Insulin
TDD \> 10 IU once/twice daily
Glimepiride as an active comparator to Sitagliptin
Sitagliptin
100 mg once daily for 6 months
Glimepiride
1 mg/2 mg/3 mg once daily
Metformin
\>=1000 mg twice daily
Insulin
TDD \> 10 IU once/twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sitagliptin
100 mg once daily for 6 months
Glimepiride
1 mg/2 mg/3 mg once daily
Metformin
\>=1000 mg twice daily
Insulin
TDD \> 10 IU once/twice daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HbA1c ≥7.3% to ≤8.5%
* Age: 25 to 60 yrs
* Insulin TDD \> 10 IU
Exclusion Criteria
* 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
25 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jothydev's Diabetes and Research Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jothydev Kesavadev, MD
Role: PRINCIPAL_INVESTIGATOR
Jothydev's Diabetes and Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jothydev's Diabetes and Research Center
Thiruvananthapuram, Kerala, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JDC/SITA/021/2011
Identifier Type: -
Identifier Source: org_study_id