Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Interventions
DRUGsitagliptin phosphate
Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
DRUGComparator: placebo
placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) \>=7.5% and \<=11% and a Fasting Plasma Glucose (FPG) \>=130 mg/dL and \<=280 mg/dL
Exclusion criteria
: * Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 | Baseline and Week 18 | A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 | Baseline and Week 18 | Change from baseline at Week 18 is defined as Week 18 minus Week 0. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | Baseline and Week 18 | Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG. |
Participant flow
Recruitment details
First Patient In: 27-Apr-2006; Last Patient Last Visit: 30-Mar-2007; Twenty-eight medical clinics (9 in China, 9 in India, and 10 in Korea).
Pre-assignment details
Patients not on an antihyperglycemic agent (AHA) or on oral single AHA or low dose dual combination therapy could participate. After an up to 6-week diet/exercise (and wash-off period for patients on AHA), patients with hemoglobin A1C 7.5-11% and fasting plasma glucose 130-280 mg/dL entered a 2-week placebo run-in period prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin 100 mg The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily. | 352 |
| Placebo The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily. | 178 |
| Total | 530 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 4 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 20 | 24 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Open-Label AHA Treatment Requested | 0 | 1 |
| Overall Study | Patient Moved | 6 | 2 |
| Overall Study | Protocol Violation | 5 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 11 |
Baseline characteristics
| Characteristic | Placebo | Total | Sitagliptin 100 mg |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 9.3 | 50.9 years STANDARD_DEVIATION 9.3 | 50.9 years STANDARD_DEVIATION 9.3 |
| Fasting Plasma Glucose (FPG) | 190.2 mg/dL STANDARD_DEVIATION 46.2 | 189.4 mg/dL STANDARD_DEVIATION 44.7 | 189.0 mg/dL STANDARD_DEVIATION 44 |
| Hemoglobin A1C (HbA1C; A1C) | 8.75 Percent STANDARD_DEVIATION 1.06 | 8.74 Percent STANDARD_DEVIATION 1.03 | 8.74 Percent STANDARD_DEVIATION 1.01 |
| Race/Ethnicity, Customized Chinese | 82 participants | 245 participants | 163 participants |
| Race/Ethnicity, Customized Indian | 63 participants | 190 participants | 127 participants |
| Race/Ethnicity, Customized Korean | 33 participants | 95 participants | 62 participants |
| Sex: Female, Male Female | 72 Participants | 224 Participants | 152 Participants |
| Sex: Female, Male Male | 106 Participants | 306 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 352 | 0 / 178 |
| serious Total, serious adverse events | 6 / 352 | 2 / 178 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Time frame: Baseline and Week 18
Population: The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin 100 mg | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 | -0.71 Percent |
| Placebo | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 | 0.31 Percent |
p-value: <0.00195% CI: [-1.23, -0.83]ANCOVA
Secondary
Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18
Change from baseline at Week 18 is defined as Week 18 minus Week 0.
Time frame: Baseline and Week 18
Population: The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin 100 mg | Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 | -63.8 mg/dL |
| Placebo | Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 | -7.2 mg/dL |
p-value: <0.00195% CI: [-68.8, -44.3]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
Time frame: Baseline and Week 18
Population: The full-analysis-set (FAS) population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Missing data were handled using the last observation carrying forward (LOCF) method.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin 100 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | -25.8 mg/dL |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | 5.2 mg/dL |
p-value: <0.00195% CI: [-38.4, -23.7]ANCOVA