Diabetes Mellitus
Conditions
Brief summary
Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin
Interventions
DRUGsitagliptin phosphate
Sitagliptin 100 mg/day - tablet for 24 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 No maximum
Healthy volunteers
No
Inclusion criteria
Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c at Week 24 | Baseline and Week 24 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c at Week 12 | Baseline and Week 12 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent |
Participant flow
Recruitment details
First patient in: 11-MAR-2008 Last patient out: 30-OCT-2009 Total number of sites: 110
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin 100mg | 608 |
| Total | 608 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 33 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 12 |
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Missing | 10 |
| Overall Study | Protocol Violation | 115 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | Sitagliptin 100mg |
|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 11.23 |
| Fasting plasma glucose | 9.3 mmol/L STANDARD_DEVIATION 2.87 |
| Hemoglobin A1c (HbA1c) | 7.73 percent STANDARD_DEVIATION 1.11 |
| Race/Ethnicity, Customized Asian | 73 participants |
| Race/Ethnicity, Customized Black | 16 participants |
| Race/Ethnicity, Customized Caucasian | 491 participants |
| Race/Ethnicity, Customized Hispanic | 6 participants |
| Race/Ethnicity, Customized Native Indian | 6 participants |
| Race/Ethnicity, Customized Other | 16 participants |
| Sex: Female, Male Female | 258 Participants |
| Sex: Female, Male Male | 350 Participants |
| Weight | 92.6 Kilograms STANDARD_DEVIATION 24.42 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 608 |
| serious Total, serious adverse events | 17 / 608 |
Outcome results
Primary
Change From Baseline in HbA1c at Week 24
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent
Time frame: Baseline and Week 24
Population: Includes all patients who received at least one dose of study medication and have a Week 24 measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin 100mg | Change From Baseline in HbA1c at Week 24 | -0.6 Percent | Standard Deviation 0.95 |
p-value: <0.001Student's T-test
Secondary
Change From Baseline in HbA1c at Week 12
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent
Time frame: Baseline and Week 12
Population: Includes all patients who received at least one dose of study medication and have a Week 12 measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin 100mg | Change From Baseline in HbA1c at Week 12 | -0.6 Percent | Standard Deviation 0.85 |