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MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

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ClinicalTrials.gov Identifier: NCT00837577
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : September 13, 2011
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Non-Insulin-Dependent
Interventions Drug: Comparator: Placebo
Drug: Sitagliptin
Drug: Voglibose
Enrollment 133
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sitagliptin/Sitagliptin Placebo/Sitagliptin
Hide Arm/Group Description Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period). Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
Period Title: Double-blind Period
Started 70 63
Completed 68 63
Not Completed 2 0
Reason Not Completed
Clinical Adverse Event             1             0
Withdrawal by Subject             1             0
Period Title: Open-label Period
Started 68 63
Completed 60 54
Not Completed 8 9
Reason Not Completed
Clinical Adverse Event             2             2
Laboratory Adverse Event             0             1
Lack of Efficacy             4             3
Withdrawal by Subject             1             2
Other Reason             1             1
Arm/Group Title Sitagliptin/Sitagliptin Placebo/Sitagliptin Total
Hide Arm/Group Description Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period). Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period). Total of all reporting groups
Overall Number of Baseline Participants 70 63 133
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 63 participants 133 participants
62.34  (10.25) 58.60  (9.73) 60.57  (10.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 63 participants 133 participants
Female
28
  40.0%
18
  28.6%
46
  34.6%
Male
42
  60.0%
45
  71.4%
87
  65.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 70 participants 63 participants 133 participants
70 63 133
Hemoglobin A1c (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 70 participants 63 participants 133 participants
7.52  (0.75) 7.50  (0.84) 7.51  (0.79)
2-hour Postprandial Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 70 participants 63 participants 133 participants
217.99  (53.22) 209.40  (52.42) 213.92  (52.82)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 70 participants 63 participants 133 participants
152.69  (37.06) 151.54  (30.57) 152.14  (34.02)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Hide Description 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%).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sitagliptin/Sitagliptin Placebo/Sitagliptin
Hide Arm/Group Description:
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
Overall Number of Participants Analyzed 70 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage of glycosylated hemoglobin
-0.76
(-0.88 to -0.63)
0.16
(0.02 to 0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Sitagliptin, Placebo/Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Adjusted for other prior antihyperglycemic medications (absence, presence).
Method Longitudinal data analysis (LDA)
Comments LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.92
Confidence Interval (2-Sided) 95%
-1.09 to -0.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in 2-hour Postprandial Glucose at Week 12
Hide Description Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sitagliptin/Sitagliptin Placebo/Sitagliptin
Hide Arm/Group Description:
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
Overall Number of Participants Analyzed 70 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-55.3
(-64.2 to -46.3)
-4.0
(-13.5 to 5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Sitagliptin, Placebo/Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Adjusted for other prior antihyperglycemic medications (absence, presence).
Method Longitudinal data analysis (LDA)
Comments LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -51.3
Confidence Interval (2-Sided) 95%
-62.3 to -40.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Hide Description Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sitagliptin/Sitagliptin Placebo/Sitagliptin
Hide Arm/Group Description:
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
Overall Number of Participants Analyzed 70 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-22.6
(-28.5 to -16.8)
-0.1
(-6.4 to 6.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Sitagliptin, Placebo/Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Adjusted for other prior antihyperglycemic medications (absence, presence).
Method Longitudinal data analysis (LDA)
Comments LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -22.5
Confidence Interval (2-Sided) 95%
-30.0 to -15.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.8
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin/Sitagliptin (Data Through Week 12) Placebo/Sitagliptin (Data Through Week 12) Pooled Sitagliptin (Data Through Week 52)
Hide Arm/Group Description Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period). Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period). 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.
All-Cause Mortality
Sitagliptin/Sitagliptin (Data Through Week 12) Placebo/Sitagliptin (Data Through Week 12) Pooled Sitagliptin (Data Through Week 52)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin/Sitagliptin (Data Through Week 12) Placebo/Sitagliptin (Data Through Week 12) Pooled Sitagliptin (Data Through Week 52)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      1/63 (1.59%)      8/133 (6.02%)    
Eye disorders       
Cataract  0/70 (0.00%)  0 0/63 (0.00%)  0 1/133 (0.75%)  2
Glaucoma  0/70 (0.00%)  0 0/63 (0.00%)  0 1/133 (0.75%)  2
Gastrointestinal disorders       
Anal Stenosis  0/70 (0.00%)  0 0/63 (0.00%)  0 1/133 (0.75%)  1
Gastric Ulcer  0/70 (0.00%)  0 0/63 (0.00%)  0 1/133 (0.75%)  1
Inguinal Hernia  0/70 (0.00%)  0 1/63 (1.59%)  1 0/133 (0.00%)  0
Infections and infestations       
Pneumonia  0/70 (0.00%)  0 0/63 (0.00%)  0 1/133 (0.75%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon Cancer  0/70 (0.00%)  0 0/63 (0.00%)  0 1/133 (0.75%)  1
Gastric Cancer  0/70 (0.00%)  0 0/63 (0.00%)  0 1/133 (0.75%)  1
Renal and urinary disorders       
Nephrolithiasis  0/70 (0.00%)  0 0/63 (0.00%)  0 1/133 (0.75%)  1
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sitagliptin/Sitagliptin (Data Through Week 12) Placebo/Sitagliptin (Data Through Week 12) Pooled Sitagliptin (Data Through Week 52)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/70 (10.00%)      5/63 (7.94%)      51/133 (38.35%)    
Infections and infestations       
Nasopharyngitis  5/70 (7.14%)  6 4/63 (6.35%)  4 40/133 (30.08%)  66
Investigations       
Blood Triglycerides Increased  1/70 (1.43%)  1 0/63 (0.00%)  0 8/133 (6.02%)  9
Musculoskeletal and connective tissue disorders       
Back Pain  1/70 (1.43%)  1 1/63 (1.59%)  1 8/133 (6.02%)  10
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00837577     History of Changes
Other Study ID Numbers: 0431-104
2009_535
First Submitted: February 3, 2009
First Posted: February 5, 2009
Results First Submitted: August 9, 2011
Results First Posted: September 13, 2011
Last Update Posted: May 15, 2017