Diabetes Mellitus Non-insulin-dependent
Conditions
Brief summary
to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.
Interventions
DRUGsitagliptin
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either: * Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months) * Or On A Single AHa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18 | Baseline and Week 18 | Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected. |
Participant flow
Recruitment details
Recruitment process occurred in the Hospital Regional de Taguatinga between November, 26 2008 and May, 27 2009. First Patient in: 26-Nov-2008; Last patient in: 27- May- 2009
Pre-assignment details
Patients between 18 and 75 years old with type 2 diabetes mellitus (T2DM) and inadequate glycemic control, who had not taken medication for at least 2 months or using a single drug for diabetes mellitus were enrolled in the study. Insulin-dependent patients were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin 100 mg Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Terminated | 10 |
Baseline characteristics
| Characteristic | Sitagliptin 100 mg |
|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 14 |
| Region of Enrollment Brazil | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
| Weight | 71.59 Kilograms STANDARD_DEVIATION 11.55 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18
Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.
Time frame: Baseline and Week 18
Population: The study was terminated early and no data were analyzed for this outcome.