Trial Outcomes & Findings for Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128) (NCT NCT00885352)
NCT ID: NCT00885352
Last Updated: 2017-05-23
Results Overview
Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
313 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2017-05-23
Participant Flow
Lab abnormalities (the reason for discontinuation cited below) included creatinine, creatinine clearance, and estimated glomerular filtration rate.
Participant milestones
| Measure |
Sitagliptin
Sitagliptin 100 mg once daily
|
Placebo
Placebo to sitagliptin once daily
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
156
|
|
Overall Study
COMPLETED
|
149
|
136
|
|
Overall Study
NOT COMPLETED
|
8
|
20
|
Reasons for withdrawal
| Measure |
Sitagliptin
Sitagliptin 100 mg once daily
|
Placebo
Placebo to sitagliptin once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Contradiction to study medication
|
0
|
2
|
|
Overall Study
Excluded medication
|
2
|
2
|
|
Overall Study
Lab abnormalities
|
1
|
1
|
Baseline Characteristics
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=157 Participants
Sitagliptin 100 mg once daily
|
Placebo
n=156 Participants
Placebo to sitagliptin once daily
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Hemoglobin A1c (A1C)
|
8.8 Percent of gylcosylated hemoglobin
STANDARD_DEVIATION 1.0 • n=5 Participants
|
8.7 Percent of gylcosylated hemoglobin
STANDARD_DEVIATION 1.0 • n=7 Participants
|
8.7 Percent of gylcosylated hemoglobin
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
2-hour post-meal glucose (PMG)
|
275.5 mg/dL
STANDARD_DEVIATION 66.4 • n=5 Participants
|
266.0 mg/dL
STANDARD_DEVIATION 62.4 • n=7 Participants
|
270.8 mg/dL
STANDARD_DEVIATION 64.5 • n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
179.3 mg/dL
STANDARD_DEVIATION 44.3 • n=5 Participants
|
173.6 mg/dL
STANDARD_DEVIATION 38.9 • n=7 Participants
|
176.5 mg/dL
STANDARD_DEVIATION 41.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.
Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.
Outcome measures
| Measure |
Sitagliptin
n=152 Participants
Sitagliptin 100 mg once daily
|
Placebo
n=153 Participants
Placebo to sitagliptin once daily
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 26
|
-1.15 Percent of glycosylated hemoglobin
95% Confidence Interval 0.93 • Interval -1.29 to -1.01
|
-0.40 Percent of glycosylated hemoglobin
95% Confidence Interval 1.00 • Interval -0.55 to -0.26
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.
Change from baseline reflects the Week 26 value minus the baseline value.
Outcome measures
| Measure |
Sitagliptin
n=141 Participants
Sitagliptin 100 mg once daily
|
Placebo
n=135 Participants
Placebo to sitagliptin once daily
|
|---|---|---|
|
Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26
|
-54.4 mg/dL
95% Confidence Interval 64.4 • Interval -63.3 to -45.4
|
-14.7 mg/dL
95% Confidence Interval 59.6 • Interval -23.8 to -5.6
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.
Change from baseline reflects the Week 26 value minus the baseline value.
Outcome measures
| Measure |
Sitagliptin
n=155 Participants
Sitagliptin 100 mg once daily
|
Placebo
n=153 Participants
Placebo to sitagliptin once daily
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
|
-20.3 mg/dL
95% Confidence Interval 49.5 • Interval -27.0 to -13.6
|
-2.8 mg/dL
95% Confidence Interval 41.6 • Interval -9.5 to 3.9
|
Adverse Events
Sitagliptin 100 mg
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin 100 mg
n=157 participants at risk
Sitagliptin 100 mg once daily
|
Placebo
n=156 participants at risk
Placebo to sitagliptin once daily
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/157 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.64%
1/156 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/157 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.64%
1/156 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/157 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.64%
1/156 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
General disorders
Chest discomfort
|
0.64%
1/157 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.00%
0/156 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/157 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.64%
1/156 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/157 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.64%
1/156 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/157 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.64%
1/156 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/157 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.64%
1/156 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/157 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.64%
1/156 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.64%
1/157 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.00%
0/156 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Renal and urinary disorders
Renal colic
|
0.64%
1/157 • Number of events 1 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
0.00%
0/156 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
Other adverse events
| Measure |
Sitagliptin 100 mg
n=157 participants at risk
Sitagliptin 100 mg once daily
|
Placebo
n=156 participants at risk
Placebo to sitagliptin once daily
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
13/157 • Number of events 13 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
9.0%
14/156 • Number of events 15 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.4%
10/157 • Number of events 23 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
4.5%
7/156 • Number of events 16 • Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant receiving rescue medication.
|
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 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