Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.
Interventions
Sitagliptin tablet 100 mg, administered once daily before the morning meal.
DRUGComparator: placebo (unspecified)
Matching placebo tablet, administered once daily before the morning meal.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participant has type 2 diabetes mellitus * Males * Females who are highly unlikely to become pregnant * Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications
Exclusion criteria
* Participant has a history of type 1 diabetes mellitus or history of ketoacidosis * Participant required insulin therapy within the prior 8 weeks * Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 | Baseline and Week 6 | Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement. |
Participant flow
Pre-assignment details
57 participants were enrolled in this study. Of these, 7 participants with normal fasting glucose (NFG) only underwent pre-randomization experiments and did not receive an allocation number, were not randomized to one of the treatment groups, and did not receive double-blind study medication.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks. | 26 |
| Placebo Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks. | 24 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Clinical Adverse Experience | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Sitagliptin | Placebo | Total |
|---|---|---|---|
| Age, Customized | 26 participants | 24 participants | 50 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 19 Participants | 16 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 1 / 26 | 0 / 24 |
Outcome results
Primary
Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
Time frame: Baseline and Week 6
Population: Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 | -83.9 mg*hr/dL | 95% Confidence Interval 87.7 |
| Placebo | Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 | 27.0 mg*hr/dL | 95% Confidence Interval 84.3 |
p-value: <0.00195% CI: [-158, -63.9]ANCOVA