Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Brief summary
The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.
Interventions
DRUGsitagliptin phosphate
sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
DRUGComparator: voglibose
voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 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
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients have type 2 diabetes mellitus on diet/exercise therapy
Exclusion criteria
* Patients have type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c at Week 12 | Baseline and Week 12 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Baseline and Week 12 | Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0. |
| Change From Baseline in 2 Hour Postprandial Glucose at Week 12 | Baseline and Week 12 | Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0. |
Participant flow
Recruitment details
Phase III. First patient in: 6 January 2007. Last patient, last visit: 15 August 2007. The study was conducted at 71 centers in Japan.
Pre-assignment details
Patients at least 20 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and \<10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin 50 mg QD The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily). | 163 |
| Voglibose 0.2 mg TID The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily). | 156 |
| Total | 319 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 |
| Overall Study | Lack of Efficacy | 2 | 5 |
| Overall Study | Patient Moved | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Voglibose 0.2 mg TID | Total | Sitagliptin 50 mg QD |
|---|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 10 | 60.7 years STANDARD_DEVIATION 10 | 60.8 years STANDARD_DEVIATION 10.1 |
| Fasting Plasma Glucose (FPG) | 148.9 mg/dL STANDARD_DEVIATION 31 | 148.8 mg/dL STANDARD_DEVIATION 32.6 | 148.7 mg/dL STANDARD_DEVIATION 34.2 |
| Hemoglobin A1c (HbA1c) | 7.8 percent STANDARD_DEVIATION 0.9 | 7.8 percent STANDARD_DEVIATION 0.9 | 7.8 percent STANDARD_DEVIATION 0.9 |
| Sex: Female, Male Female | 62 Participants | 107 Participants | 45 Participants |
| Sex: Female, Male Male | 94 Participants | 212 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / — | 62 / — |
| serious Total, serious adverse events | 1 / — | 2 / — |
Outcome results
Primary
Change From Baseline in HbA1c at Week 12
HbA1c is measured as a 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: The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for major protocol violations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin 50 mg QD | Change From Baseline in HbA1c at Week 12 | -0.70 Percent |
| Voglibose 0.2 mg TID | Change From Baseline in HbA1c at Week 12 | -0.30 Percent |
p-value: <0.00195% CI: [-0.51, -0.28]ANCOVA
Secondary
Change From Baseline in 2 Hour Postprandial Glucose at Week 12
Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.
Time frame: Baseline and Week 12
Population: The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin 50 mg QD | Change From Baseline in 2 Hour Postprandial Glucose at Week 12 | -51.0 mg/dL |
| Voglibose 0.2 mg TID | Change From Baseline in 2 Hour Postprandial Glucose at Week 12 | -32.2 mg/dL |
p-value: <0.00195% CI: [-26.7, -10.9]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 12
Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.
Time frame: Baseline and Week 12
Population: The Per Protocol Population included patients with baseline and Week 12 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sitagliptin 50 mg QD | Change From Baseline in Fasting Plasma Glucose at Week 12 | -19.6 mg/dL |
| Voglibose 0.2 mg TID | Change From Baseline in Fasting Plasma Glucose at Week 12 | -8.9 mg/dL |
p-value: <0.00195% CI: [-15.3, -6.2]ANCOVA