Trial Outcomes & Findings for MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104) (NCT NCT00837577)
NCT ID: NCT00837577
Last Updated: 2017-05-15
Results Overview
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c \[National Glycohemoglobin Standardization Program; NGSP\] = HbA1c (JDS-HbA1c \[%\]) + 0.4%).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
133 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Sitagliptin/Sitagliptin
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
|
Placebo/Sitagliptin
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
|
|---|---|---|
|
Double-blind Period
STARTED
|
70
|
63
|
|
Double-blind Period
COMPLETED
|
68
|
63
|
|
Double-blind Period
NOT COMPLETED
|
2
|
0
|
|
Open-label Period
STARTED
|
68
|
63
|
|
Open-label Period
COMPLETED
|
60
|
54
|
|
Open-label Period
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Sitagliptin/Sitagliptin
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
|
Placebo/Sitagliptin
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
|
|---|---|---|
|
Double-blind Period
Clinical Adverse Event
|
1
|
0
|
|
Double-blind Period
Withdrawal by Subject
|
1
|
0
|
|
Open-label Period
Clinical Adverse Event
|
2
|
2
|
|
Open-label Period
Laboratory Adverse Event
|
0
|
1
|
|
Open-label Period
Lack of Efficacy
|
4
|
3
|
|
Open-label Period
Withdrawal by Subject
|
1
|
2
|
|
Open-label Period
Other Reason
|
1
|
1
|
Baseline Characteristics
MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)
Baseline characteristics by cohort
| Measure |
Sitagliptin/Sitagliptin
n=70 Participants
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
|
Placebo/Sitagliptin
n=63 Participants
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.34 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
58.60 years
STANDARD_DEVIATION 9.73 • n=7 Participants
|
60.57 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
70 participants
n=5 Participants
|
63 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.52 Percent
STANDARD_DEVIATION 0.75 • n=5 Participants
|
7.50 Percent
STANDARD_DEVIATION 0.84 • n=7 Participants
|
7.51 Percent
STANDARD_DEVIATION 0.79 • n=5 Participants
|
|
2-hour Postprandial Glucose
|
217.99 mg/dL
STANDARD_DEVIATION 53.22 • n=5 Participants
|
209.40 mg/dL
STANDARD_DEVIATION 52.42 • n=7 Participants
|
213.92 mg/dL
STANDARD_DEVIATION 52.82 • n=5 Participants
|
|
Fasting Plasma Glucose (FPG)
|
152.69 mg/dL
STANDARD_DEVIATION 37.06 • n=5 Participants
|
151.54 mg/dL
STANDARD_DEVIATION 30.57 • n=7 Participants
|
152.14 mg/dL
STANDARD_DEVIATION 34.02 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c \[National Glycohemoglobin Standardization Program; NGSP\] = HbA1c (JDS-HbA1c \[%\]) + 0.4%).
Outcome measures
| Measure |
Sitagliptin/Sitagliptin
n=70 Participants
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
|
Placebo/Sitagliptin
n=63 Participants
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
|
-0.76 Percentage of glycosylated hemoglobin
95% Confidence Interval 0.42 • Interval -0.88 to -0.63
|
0.16 Percentage of glycosylated hemoglobin
95% Confidence Interval 0.64 • Interval 0.02 to 0.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin
n=70 Participants
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
|
Placebo/Sitagliptin
n=63 Participants
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
|
|---|---|---|
|
Change From Baseline in 2-hour Postprandial Glucose at Week 12
|
-55.3 mg/dL
95% Confidence Interval 37.9 • Interval -64.2 to -46.3
|
-4.0 mg/dL
95% Confidence Interval 38.7 • Interval -13.5 to 5.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Outcome measures
| Measure |
Sitagliptin/Sitagliptin
n=70 Participants
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
|
Placebo/Sitagliptin
n=63 Participants
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
|
-22.6 mg/dL
95% Confidence Interval 27.1 • Interval -28.5 to -16.8
|
-0.1 mg/dL
95% Confidence Interval 22.2 • Interval -6.4 to 6.2
|
Adverse Events
Sitagliptin/Sitagliptin (Data Through Week 12)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo/Sitagliptin (Data Through Week 12)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Pooled Sitagliptin (Data Through Week 52)
Serious events: 8 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin/Sitagliptin (Data Through Week 12)
n=70 participants at risk
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
|
Placebo/Sitagliptin (Data Through Week 12)
n=63 participants at risk
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
|
Pooled Sitagliptin (Data Through Week 52)
n=133 participants at risk
The Pooled Sitagliptin group includes data from all participants who took sitagliptin in either treatment group: data from Week 0 to Week 52 for participants in the Sitagliptin/Sitagliptin group; data from Weeks 12 through Week 52 for participants in the Placebo/Sitagliptin group; and data from participants in either group who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
|
|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/70
|
0.00%
0/63
|
0.75%
1/133 • Number of events 2
|
|
Eye disorders
Glaucoma
|
0.00%
0/70
|
0.00%
0/63
|
0.75%
1/133 • Number of events 2
|
|
Gastrointestinal disorders
Anal Stenosis
|
0.00%
0/70
|
0.00%
0/63
|
0.75%
1/133 • Number of events 1
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/70
|
0.00%
0/63
|
0.75%
1/133 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/70
|
1.6%
1/63 • Number of events 1
|
0.00%
0/133
|
|
Infections and infestations
Pneumonia
|
0.00%
0/70
|
0.00%
0/63
|
0.75%
1/133 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/70
|
0.00%
0/63
|
0.75%
1/133 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/70
|
0.00%
0/63
|
0.75%
1/133 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/70
|
0.00%
0/63
|
0.75%
1/133 • Number of events 1
|
Other adverse events
| Measure |
Sitagliptin/Sitagliptin (Data Through Week 12)
n=70 participants at risk
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
|
Placebo/Sitagliptin (Data Through Week 12)
n=63 participants at risk
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
|
Pooled Sitagliptin (Data Through Week 52)
n=133 participants at risk
The Pooled Sitagliptin group includes data from all participants who took sitagliptin in either treatment group: data from Week 0 to Week 52 for participants in the Sitagliptin/Sitagliptin group; data from Weeks 12 through Week 52 for participants in the Placebo/Sitagliptin group; and data from participants in either group who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.1%
5/70 • Number of events 6
|
6.3%
4/63 • Number of events 4
|
30.1%
40/133 • Number of events 66
|
|
Investigations
Blood Triglycerides Increased
|
1.4%
1/70 • Number of events 1
|
0.00%
0/63
|
6.0%
8/133 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
1/70 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
6.0%
8/133 • Number of events 10
|
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 only disclosure restriction on the PI is that the sponsor must have the opportunity to review all communications regarding trial results for 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