Diabetes Mellitus
Conditions
Brief summary
After 24 weeks of treatment evaluate the efficacy and security.
Interventions
DRUGsitagliptin phosphate
Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Patients Being Treated With Metformin * Patients With Hba1c Between 6.5 % And 12.0%. * Type 2 DM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in A1C at Week 24 | Baseline and 24 Weeks | Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values. |
Participant flow
Recruitment details
Single site study with patients recruited in Principal Investigator's private practice, Mexico City. First Patient In: 14Feb2007. Last Patient's Last Visit: 11Jul2008
Pre-assignment details
Treatment naïve patients (30 to 78 years of age) with inadequate glycemic control on diet/exercise were assigned to treatment with sitagliptin alone (A1C 6.5 to \<8%), sitagliptin + metformin as initial combination therapy (A1C 8-12%), or standard care.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin 100 mg q.d. (Once Daily) | 12 |
| Sitagliptin 100 mg q.d. (Once Daily) and Metformin | 16 |
| Standard Care Regimen Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group. | 1 |
| Total | 29 |
Baseline characteristics
| Characteristic | Sitagliptin 100 mg q.d. (Once Daily) | Sitagliptin 100 mg q.d. (Once Daily) and Metformin | Standard Care Regimen | Total |
|---|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 14.1 | 52.5 years STANDARD_DEVIATION 9.3 | 51.0 years STANDARD_DEVIATION 0 | 54.62 years STANDARD_DEVIATION 11.43 |
| Body Mass Index (BMI) | 27.4 kg/m2 STANDARD_DEVIATION 10 | 28.9 kg/m2 STANDARD_DEVIATION 5.2 | 26.0 kg/m2 STANDARD_DEVIATION 0 | 28.14 kg/m2 STANDARD_DEVIATION 7.41 |
| Glycosylated Hemoglobin A1C (A1C) | 7.1 Percent STANDARD_DEVIATION 0.6 | 8.6 Percent STANDARD_DEVIATION 1.4 | 6.9 Percent STANDARD_DEVIATION 0 | 7.96 Percent STANDARD_DEVIATION 1.33 |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 1 Participants | 20 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 0 Participants | 9 Participants |
| Time Since Diagnosis of Diabetes | 5.3 Years STANDARD_DEVIATION 7 | 6.2 Years STANDARD_DEVIATION 6 | 5.2 Years STANDARD_DEVIATION 0 | 5.82 Years STANDARD_DEVIATION 6.25 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 0 / 16 | 0 / 1 |
| serious Total, serious adverse events | 0 / 12 | 0 / 16 | 0 / 1 |
Outcome results
Primary
Change From Baseline in A1C at Week 24
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values.
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sitagliptin 100 mg q.d. (Once Daily) | Change From Baseline in A1C at Week 24 | -0.2 Percent Difference |
| Sitagliptin 100 mg q.d. (Once Daily) and Metformin | Change From Baseline in A1C at Week 24 | -1.0 Percent Difference |
| Standard Care Regimen | Change From Baseline in A1C at Week 24 | 0.0 Percent Difference |