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Randomized Sitagliptin Withdrawal Study (MK-0431-845)
Plain-language guide to NCT02738879: phase 3 randomized trial of Insulin Glargine, 746 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02738879
- Phase
- phase 3
- Status
- completed
- Start
- 2016-05-09
- Completion (planned or actual)
- 2018-01-22
- Participants
- 746 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Glargine.
It had two arms (groups): Sitagliptin (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
746 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have T2DM based on American Diabetes Association guidelines. Be on one of the following treatment regimens:. Meet one of the following categories:. The participant is a male. The participant is a female who is not of reproductive potential.
The full record lists 11 inclusion and 4 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.
Those kept unaware of assignments: participant and investigator.
It started in 2016-05-09 with completion listed for 2018-01-22.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in A1C at Week 30 (time frame: Baseline and Week 30). Percentage of Participants Who Discontinued Study Drug Due to an AE (time frame: Up to 30 weeks). Percentage of Participants Who Experienced One or More Adverse Events (AEs) (time frame: Up to 32 weeks).
It also tracked 11 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 746 people.
With 746 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin Glargine compound page, all human trials.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.