Trial Outcomes & Findings for Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801) (NCT NCT00541775)
NCT ID: NCT00541775
Last Updated: 2015-08-24
Results Overview
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
273 participants
Primary outcome timeframe
Baseline and 18 Weeks
Results posted on
2015-08-24
Participant Flow
First Patient In: 16-June-2006. Last Patient Last Visit: 2-March-2007. 13 medical clinics in 3 countries in Europe and 23 in 4 countries in the rest of the world
Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) who were taking metformin monotherapy at a stable dose of ≥ 1500 mg/day for at least 10 weeks and had inadequate glycemic control (hemoglobin A1C ≥ 7.0% and ≤11%) were eligible to participate.
Participant milestones
| Measure |
Sitagliptin
The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
|
Rosiglitazone
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
|
Placebo
The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
|
|---|---|---|---|
|
Overall Study
STARTED
|
94
|
87
|
92
|
|
Overall Study
COMPLETED
|
85
|
85
|
84
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
8
|
Reasons for withdrawal
| Measure |
Sitagliptin
The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
|
Rosiglitazone
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
|
Placebo
The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject and Other
|
5
|
0
|
2
|
Baseline Characteristics
Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=94 Participants
The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
|
Rosiglitazone
n=87 Participants
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
|
Placebo
n=92 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
55.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
57 participants
n=5 Participants
|
51 participants
n=7 Participants
|
56 participants
n=5 Participants
|
164 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
36 participants
n=5 Participants
|
33 participants
n=7 Participants
|
36 participants
n=5 Participants
|
105 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Fasting Plasma Glucose (FPG)
|
157.5 mg/dL
STANDARD_DEVIATION 31.4 • n=5 Participants
|
156.9 mg/dL
STANDARD_DEVIATION 31.6 • n=7 Participants
|
160.0 mg/dL
STANDARD_DEVIATION 37.4 • n=5 Participants
|
158.1 mg/dL
STANDARD_DEVIATION 33.5 • n=4 Participants
|
|
Hemoglobin A1C (A1C)
|
7.8 Percent of glycosylated hemoglobin (A1C)
STANDARD_DEVIATION 1.0 • n=5 Participants
|
7.7 Percent of glycosylated hemoglobin (A1C)
STANDARD_DEVIATION 0.8 • n=7 Participants
|
7.7 Percent of glycosylated hemoglobin (A1C)
STANDARD_DEVIATION 0.9 • n=5 Participants
|
7.7 Percent of glycosylated hemoglobin (A1C)
STANDARD_DEVIATION 0.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 18 WeeksPopulation: The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo.
Outcome measures
| Measure |
Sitagliptin
n=91 Participants
The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
|
Rosiglitazone
n=87 Participants
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
|
Placebo
n=88 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
|
|---|---|---|---|
|
Hemoglobin A1C (A1C) at Week 18
|
-0.73 Percent of glycosylated hemoglobin (A1C)
Interval -0.87 to -0.6
|
-0.79 Percent of glycosylated hemoglobin (A1C)
Interval -0.92 to -0.65
|
-0.22 Percent of glycosylated hemoglobin (A1C)
Interval -0.36 to -0.08
|
SECONDARY outcome
Timeframe: Baseline and 18 WeeksPopulation: The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.
The change from baseline is the Week 18 FPG minus the Week 0 FPG.
Outcome measures
| Measure |
Sitagliptin
n=92 Participants
The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
|
Rosiglitazone
n=87 Participants
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
|
Placebo
n=89 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
|
|---|---|---|---|
|
Fasting Plasma Glucose (FPG) at Week 18
|
-11.7 mg/dL
Interval -18.6 to -4.9
|
-24.5 mg/dL
Interval -31.6 to -17.5
|
6.1 mg/dL
Interval -0.8 to 13.1
|
SECONDARY outcome
Timeframe: Baseline and 18 WeeksPopulation: The all patients treated population included all patients who took at least one dose of study medication and had both a baseline measurement and at least one post-randomization measurement for this outcome. Missing data were imputed using the last observation carried forward (LOCF) method.
The change from baseline is the Week 18 PMG minus the Week 0 PMG.
Outcome measures
| Measure |
Sitagliptin
n=80 Participants
The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
|
Rosiglitazone
n=76 Participants
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
|
Placebo
n=78 Participants
The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
|
|---|---|---|---|
|
2-hour Post-meal Glucose (PMG) at Week 18
|
-35.4 mg/dL
Interval -46.3 to -24.5
|
-51.3 mg/dL
Interval -62.5 to -40.1
|
-4.9 mg/dL
Interval -16.0 to 6.1
|
Adverse Events
Sitagliptin
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Rosiglitazone
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin
n=94 participants at risk
The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
|
Rosiglitazone
n=87 participants at risk
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
|
Placebo
n=91 participants at risk
The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
|
|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
1.1%
1/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
1/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
1.1%
1/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.1%
2/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
3.4%
3/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
2.2%
2/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.1%
1/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
1.1%
1/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
|
Nervous system disorders
Syncope
|
0.00%
0/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
1.1%
1/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
1.1%
1/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
1.1%
1/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
Other adverse events
| Measure |
Sitagliptin
n=94 participants at risk
The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
|
Rosiglitazone
n=87 participants at risk
The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
|
Placebo
n=91 participants at risk
The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
|
|---|---|---|---|
|
Investigations
Blood glucose increased
|
5.3%
5/94 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
1.1%
1/87 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
0.00%
0/91 • Weeks 0 to 18
Safety tables are based on the All Patients as Treated (APaT) population that includes all patients who took at least one dose of study drug. One patient in the placebo group did not take any study drug. Thus, for the placebo group 92 patients are reported in the baseline characteristics and 91 patients are reported in the AE summary.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
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