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Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
Plain-language guide to NCT01341717: phase 4 randomized trial of Insulin (regular human), 440 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01341717
- Phase
- phase 4
- Status
- completed
- Start
- 2012-02
- Completion (planned or actual)
- 2014-05
- Participants
- 440 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin (regular human).
It had two arms (groups): Sitagliptin along with metformin and insulin (experimental) and Glimepiride as an active comparator to Sitagliptin (active comparator).
The registry classes the interventions as drug.
More on the Plan
DPP-4 inhibitors enhance function of endogenous incretin that helps with glucose homoeostasis.
It could be clinically useful to add sitaglipin to treatment regimen of T2DM patients on stable therapy with insulin \& metformin.
Who Took Part
Enrollment: 440 actual participants took part.
It was open to people of any sex aged from 25 years up to 60 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: T2DM patients on metformin and biphasic or basal regimens of insulin. Age: 25 to 60 yrs.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: use of acarbose, pioglitazone or short-acting insulin analogues at time of run-in phase; 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.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
The Insulin (regular human) group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
It started in 2012-02 with completion listed for 2014-05.
It ran at 1 site in India.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 7 secondary outcomes, for example Episodes of hypoglycemia, change in weight and BMI, Change in both HbA1c and TDD, Change in insulin resistance and beta cell function and Change in lipid profile from baseline.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 440 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.