Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Brief summary
A 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
100 mg once daily (QD), taken orally for 4 weeks
DRUGComparator: Placebo
Placebo tablet, QD, taken orally for 4 weeks
50 mg twice daily (BID), taken orally for 4 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 69 Years
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 24-hour Weighted Mean Plasma Glucose | Baseline and Week 4 | Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma Glucose | Baseline and Week 4 | Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0. |
Participant flow
Recruitment details
Phase II. First patient in: 31 July 2005. Last patient, last visit: 13 February 2006. The study was conducted at 8 centers in Japan.
Pre-assignment details
Patients 20-69 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 100 mg QD The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). | 27 |
| Sitagliptin 50 mg BID The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily). | 25 |
| Placebo The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally. | 28 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Incorrect Study Drug | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Sitagliptin 100 mg QD | Total | Placebo | Sitagliptin 50 mg BID |
|---|---|---|---|---|
| 24-hour weighted mean plasma glucose (24hr-WMG) | 195.0 mg/dL STANDARD_DEVIATION 55.6 | 193.2 mg/dL STANDARD_DEVIATION 49.1 | 195.4 mg/dL STANDARD_DEVIATION 46.2 | 188.9 mg/dL STANDARD_DEVIATION 46.6 |
| Age, Continuous | 54.2 years STANDARD_DEVIATION 8.9 | 54.6 years STANDARD_DEVIATION 9.4 | 53.6 years STANDARD_DEVIATION 10.3 | 56.1 years STANDARD_DEVIATION 8.9 |
| Fasting Plasma Glucose (FPG) | 158.6 mg/dL STANDARD_DEVIATION 41 | 159.9 mg/dL STANDARD_DEVIATION 39.3 | 164.1 mg/dL STANDARD_DEVIATION 36.9 | 156.4 mg/dL STANDARD_DEVIATION 41.3 |
| Sex: Female, Male Female | 10 Participants | 25 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Male | 17 Participants | 55 Participants | 20 Participants | 18 Participants |
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 / — | 1 / — | 2 / — |
| serious Total, serious adverse events | 1 / — | 2 / — | 0 / — |
Outcome results
Primary
Change From Baseline in 24-hour Weighted Mean Plasma Glucose
Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.
Time frame: Baseline and Week 4
Population: The Per Protocol population included patients with baseline and Week 4 (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 100 mg QD | Change From Baseline in 24-hour Weighted Mean Plasma Glucose | -34.9 mg/dL |
| Sitagliptin 50 mg BID | Change From Baseline in 24-hour Weighted Mean Plasma Glucose | -28.6 mg/dL |
| Placebo | Change From Baseline in 24-hour Weighted Mean Plasma Glucose | -9.0 mg/dL |
p-value: <0.00195% CI: [-34.2, -17.5]ANCOVA
p-value: <0.00195% CI: [-28, -11.1]ANCOVA
Secondary
Change From Baseline in Plasma Glucose
Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.
Time frame: Baseline and Week 4
Population: The Per Protocol population included patients with baseline and Week 4 (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 100 mg QD | Change From Baseline in Plasma Glucose | -22.3 mg/dL |
| Sitagliptin 50 mg BID | Change From Baseline in Plasma Glucose | -16.0 mg/dL |
| Placebo | Change From Baseline in Plasma Glucose | -3.1 mg/dL |
p-value: <0.00195% CI: [-26.6, -11.9]ANCOVA
p-value: <0.00195% CI: [-20.4, -5.4]ANCOVA