Trial Outcomes & Findings for MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040) (NCT NCT00289848)
NCT ID: NCT00289848
Last Updated: 2015-06-15
Results Overview
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
COMPLETED
PHASE3
530 participants
Baseline and Week 18
2015-06-15
Participant Flow
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).
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.
Participant milestones
| Measure |
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.
|
Placebo
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
352
|
178
|
|
Overall Study
COMPLETED
|
306
|
133
|
|
Overall Study
NOT COMPLETED
|
46
|
45
|
Reasons for withdrawal
| Measure |
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.
|
Placebo
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
|
|---|---|---|
|
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
Protocol Violation
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
11
|
|
Overall Study
Patient Moved
|
6
|
2
|
|
Overall Study
Open-Label AHA Treatment Requested
|
0
|
1
|
Baseline Characteristics
MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
Baseline characteristics by cohort
| Measure |
Sitagliptin 100 mg
n=352 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Placebo
n=178 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
|
Total
n=530 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
200 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
163 participants
n=5 Participants
|
82 participants
n=7 Participants
|
245 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
127 participants
n=5 Participants
|
63 participants
n=7 Participants
|
190 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
62 participants
n=5 Participants
|
33 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Fasting Plasma Glucose (FPG)
|
189.0 mg/dL
STANDARD_DEVIATION 44.0 • n=5 Participants
|
190.2 mg/dL
STANDARD_DEVIATION 46.2 • n=7 Participants
|
189.4 mg/dL
STANDARD_DEVIATION 44.7 • n=5 Participants
|
|
Hemoglobin A1C (HbA1C; A1C)
|
8.74 Percent
STANDARD_DEVIATION 1.01 • n=5 Participants
|
8.75 Percent
STANDARD_DEVIATION 1.06 • n=7 Participants
|
8.74 Percent
STANDARD_DEVIATION 1.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 18Population: 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.
A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=339 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Placebo
n=169 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
|
-0.71 Percent
Interval -0.84 to -0.59
|
0.31 Percent
Interval 0.14 to 0.48
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: 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.
Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=339 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Placebo
n=169 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
|
-25.8 mg/dL
Interval -30.3 to -21.3
|
5.2 mg/dL
Interval -1.0 to 11.4
|
SECONDARY outcome
Timeframe: Baseline and Week 18Population: 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.
Change from baseline at Week 18 is defined as Week 18 minus Week 0.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=297 Participants
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Placebo
n=131 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
|
|---|---|---|
|
Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18
|
-63.8 mg/dL
Interval -71.0 to -56.6
|
-7.2 mg/dL
Interval -17.7 to 3.3
|
Adverse Events
Sitagliptin 100 mg
Placebo
Serious adverse events
| Measure |
Sitagliptin 100 mg
n=352 participants at risk
The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
|
Placebo
n=178 participants at risk
The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
|
|---|---|---|
|
Cardiac disorders
Any Cardiac Disorders
|
0.28%
1/352
|
0.56%
1/178
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/352
|
0.56%
1/178
|
|
Cardiac disorders
Myocardial Infarction
|
0.28%
1/352
|
0.00%
0/178
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/352
|
0.56%
1/178
|
|
Hepatobiliary disorders
Any Hepatobiliary Disorders
|
0.28%
1/352
|
0.00%
0/178
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.28%
1/352
|
0.00%
0/178
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.28%
1/352
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Neoplasms Benign, Malignant And Unspecified (Incl Cysts & Polyps)
|
0.57%
2/352
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Of The Gastrointestinal Tract
|
0.28%
1/352
|
0.00%
0/178
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Epithelial Cancer
|
0.28%
1/352
|
0.00%
0/178
|
|
Nervous system disorders
Any Nervous System Disorders
|
0.28%
1/352
|
0.00%
0/178
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.28%
1/352
|
0.00%
0/178
|
|
Psychiatric disorders
Any Psychiatric Disorders
|
0.00%
0/352
|
0.56%
1/178
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/352
|
0.56%
1/178
|
|
Respiratory, thoracic and mediastinal disorders
Any Respiratory, Thoracic And Mediastinal Disorders
|
0.28%
1/352
|
0.00%
0/178
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.28%
1/352
|
0.00%
0/178
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER