Trial Outcomes & Findings for A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074) (NCT NCT00813995)
NCT ID: NCT00813995
Last Updated: 2017-05-12
Results Overview
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
COMPLETED
PHASE3
395 participants
Baseline and Week 24
2017-05-12
Participant Flow
Participant milestones
| Measure |
Sitagliptin
Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
|
Placebo
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
197
|
198
|
|
Overall Study
COMPLETED
|
174
|
182
|
|
Overall Study
NOT COMPLETED
|
23
|
16
|
Reasons for withdrawal
| Measure |
Sitagliptin
Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
|
Placebo
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
|
|---|---|---|
|
Overall Study
Clinical adverse event
|
9
|
3
|
|
Overall Study
Laboratory adverse event
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Other reason
|
2
|
2
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Subject moved
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=197 Participants
Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
|
Placebo
n=198 Participants
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
|
Total
n=395 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 9.0 • n=93 Participants
|
55.1 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
54.6 years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
195 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
200 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
197 participants
n=93 Participants
|
198 participants
n=4 Participants
|
395 participants
n=27 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.5 Percent
STANDARD_DEVIATION 0.9 • n=93 Participants
|
8.5 Percent
STANDARD_DEVIATION 0.9 • n=4 Participants
|
8.5 Percent
STANDARD_DEVIATION 0.9 • n=27 Participants
|
|
2-hour Post-meal Glucose
|
258.0 mg/dL
STANDARD_DEVIATION 58.0 • n=93 Participants
|
258.7 mg/dL
STANDARD_DEVIATION 63.2 • n=4 Participants
|
258.3 mg/dL
STANDARD_DEVIATION 60.6 • n=27 Participants
|
|
Fasting Plasma Glucose
|
173.4 mg/dL
STANDARD_DEVIATION 39.3 • n=93 Participants
|
173.9 mg/dL
STANDARD_DEVIATION 40.0 • n=4 Participants
|
173.7 mg/dL
STANDARD_DEVIATION 39.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \[randomization\] measurement and a post-randomization measurement) using last observation carried forward for missing data.
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Sitagliptin
n=191 Participants
Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
|
Placebo
n=194 Participants
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
|
-1.02 Percent
95% Confidence Interval 0.99 • Interval -1.16 to -0.87
|
-0.14 Percent
95% Confidence Interval 1.22 • Interval -0.28 to 0.01
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \[randomization\] measurement and a post-randomization measurement) using last observation carried forward for missing data.
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Sitagliptin
n=94 Participants
Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
|
Placebo
n=97 Participants
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day
|
-0.84 Percent
95% Confidence Interval 1.09 • Interval -1.07 to -0.62
|
-0.01 Percent
95% Confidence Interval 1.31 • Interval -0.23 to 0.2
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \[randomization\] measurement and a post-randomization measurement) using last observation carried forward for missing data.
A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Outcome measures
| Measure |
Sitagliptin
n=97 Participants
Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
|
Placebo
n=97 Participants
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day
|
-1.14 Percent
95% Confidence Interval 0.88 • Interval -1.35 to -0.93
|
-0.21 Percent
95% Confidence Interval 1.12 • Interval -0.43 to 0.02
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \[randomization\] measurement and a post-randomization measurement) using last observation carried forward for missing data.
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Outcome measures
| Measure |
Sitagliptin
n=173 Participants
Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
|
Placebo
n=163 Participants
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
|
|---|---|---|
|
Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24
|
-43.4 mg/dL
95% Confidence Interval 57.3 • Interval -51.5 to -35.3
|
-10.0 mg/dL
95% Confidence Interval 60.0 • Interval -18.4 to -1.7
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline \[randomization\] measurement and a post-randomization measurement) using last observation carried forward for missing data.
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Outcome measures
| Measure |
Sitagliptin
n=191 Participants
Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
|
Placebo
n=195 Participants
Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
|
-20.3 mg/dL
95% Confidence Interval 39.1 • Interval -26.2 to -14.5
|
0.5 mg/dL
95% Confidence Interval 40.1 • Interval -5.3 to 6.4
|
Adverse Events
Sitagliptin
Placebo
Serious adverse events
| Measure |
Sitagliptin
n=197 participants at risk
|
Placebo
n=198 participants at risk
|
|---|---|---|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.51%
1/197 • Number of events 1
|
0.00%
0/198
|
|
Injury, poisoning and procedural complications
SPINAL CORD INJURY CERVICAL
|
0.00%
0/197
|
0.51%
1/198 • Number of events 1
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/197
|
0.51%
1/198 • Number of events 1
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.51%
1/197 • Number of events 1
|
0.00%
0/198
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.51%
1/197 • Number of events 1
|
0.00%
0/198
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
0.00%
0/197
|
0.51%
1/198 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/197
|
0.51%
1/198 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIP AND/OR ORAL CAVITY CANCER
|
0.51%
1/197 • Number of events 1
|
0.00%
0/198
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
1.0%
2/197 • Number of events 2
|
0.00%
0/198
|
|
Nervous system disorders
IIIrd NERVE PARALYSIS
|
0.51%
1/197 • Number of events 1
|
0.00%
0/198
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/197
|
0.51%
1/198 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
EPIGLOTTIC CYST
|
0.51%
1/197 • Number of events 1
|
0.00%
0/198
|
Other adverse events
| Measure |
Sitagliptin
n=197 participants at risk
|
Placebo
n=198 participants at risk
|
|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.1%
10/197 • Number of events 12
|
6.6%
13/198 • Number of events 14
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Following the multicenter publication or 24 months after study completion, whichever comes first, an investigator may publish the results for their study site independently. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER