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A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)

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ClinicalTrials.gov Identifier: NCT01702298
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : May 30, 2014
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Sitagliptin 100 mg/simvastatin 40 mg FDC
Drug: Metformin
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Period Title: Overall Study
Started 42
Completed 41
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
All participants enrolled
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
48.3  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
19
  45.2%
Male
23
  54.8%
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 42 participants
159.3  (40.9)
Low-density lipoprotein cholesterol (LDL-C)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 42 participants
109.6  (27.2)
Total Cholesterol (TC)  
Mean (Standard Deviation)
Unit of measure:  md/dL
Number Analyzed 42 participants
195.2  (36.4)
(Non-High-Density Lipoprotein Cholesterol (non-HDL-C)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 42 participants
152.0  (37.9)
Triglycerides (TG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 42 participants
225.3  (152.5)
High-Density Lipoprotein Cholesterol (HDL-C)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 42 participants
43.1  (11.9)
1.Primary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG)
Hide Description Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) defined as all participants who took at least one dose of study medication and had at least one baseline or post-baseline measurement.
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description:
Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Participants Analyzed 42
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-27.6
(-46.0 to -9.3)
2.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event
Hide Description An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.
Time Frame Up to 8 weeks (including 14 days after final dose of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated population defined as all enrolled participants who received at least one dose of study treatment.
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description:
Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
9.5
(2.7 to 22.6)
3.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Hide Description Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.
Time Frame Up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated population defined as all enrolled participants who received at least one dose of study treatment.
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description:
Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: Participants
0
4.Secondary Outcome
Title Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Hide Description Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of LDL-C.
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description:
Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Participants Analyzed 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-46.5
(-51.9 to -41.2)
5.Secondary Outcome
Title Change From Baseline in Total Cholesterol (TC)
Hide Description Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description

FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements.

One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of TC.

Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description:
Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Participants Analyzed 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-33.7
(-37.3 to -30.0)
6.Secondary Outcome
Title Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)
Hide Description Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of non-HDL-C.
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description:
Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Participants Analyzed 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
-43.1
(-47.4 to -38.9)
7.Secondary Outcome
Title Change From Baseline in Triglycerides (TG)
Hide Description Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS.
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description:
Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Participants Analyzed 41
Median (95% Confidence Interval)
Unit of Measure: Percent change
-31.8
(-41.1 to -18.3)
8.Secondary Outcome
Title Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Hide Description Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
Time Frame Baseline and Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of HDL-C.
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description:
Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
Overall Number of Participants Analyzed 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
1.3
(-5.0 to 7.5)
Time Frame Up to 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin 100 mg/Simvastatin 40 mg FDC
Hide Arm/Group Description Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
All-Cause Mortality
Sitagliptin 100 mg/Simvastatin 40 mg FDC
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Sitagliptin 100 mg/Simvastatin 40 mg FDC
Affected / at Risk (%) # Events
Total   0/42 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sitagliptin 100 mg/Simvastatin 40 mg FDC
Affected / at Risk (%) # Events
Total   3/42 (7.14%)    
Metabolism and nutrition disorders   
Hypoglycemia  1  3/42 (7.14%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01702298    
Other Study ID Numbers: 0431D-312
First Submitted: October 4, 2012
First Posted: October 8, 2012
Results First Submitted: May 1, 2014
Results First Posted: May 30, 2014
Last Update Posted: August 24, 2018