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MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00482729
Recruitment Status : Completed
First Posted : June 5, 2007
Results First Posted : March 15, 2010
Last Update Posted : June 9, 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 Type 2 Diabetes Mellitus
Interventions Drug: sitagliptin phosphate (+) metformin hydrochloride
Drug: metformin
Enrollment 1246
Recruitment Details First Patient In: 26-Jun-2007; Last Patient Last Visit for end of study: 28-Apr-2009; Two-hundred four medical clinics in the United States (US) and 5 in Puerto Rico.
Pre-assignment Details Patients 18-78 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (hemoglobin A1c [A1C] >7.5% at screening visit) who were appropriate for treatment with oral antihyperglycemic therapy and had not been on an anti-hyperglycemic agent (AHA) in the last 4 months were eligible to participate.
Arm/Group Title Sita/Met FDC Metformin
Hide Arm/Group Description The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Period Title: Overall Study
Started 626 [1] 624 [2]
Completed Phase A 484 482
Completed Phase B 409 406
Completed 409 406
Not Completed 217 218
Reason Not Completed
Adverse Event             29             33
Creatinine/Creatinine Clearance Criteria             0             2
Hyperglycemia Criteria             7             5
Lack of Efficacy             4             16
Lost to Follow-up             86             66
Physician Decision             10             7
Pregnancy             4             2
Protocol Violation             10             18
Withdrawal by Subject             67             69
[1]
Site 079011301 was identified as non-compliant and 1 patient was excluded from all analysis
[2]
Site 079011301 was identified as non-compliant and 3 patients were excluded from all analysis
Arm/Group Title Sita/Met FDC Metformin Total
Hide Arm/Group Description The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. Total of all reporting groups
Overall Number of Baseline Participants 625 621 1246
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 625 participants 621 participants 1246 participants
49.4  (10.5) 50.0  (10.5) 49.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 625 participants 621 participants 1246 participants
Female
272
  43.5%
266
  42.8%
538
  43.2%
Male
353
  56.5%
355
  57.2%
708
  56.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 625 participants 621 participants 1246 participants
Asian 17 24 41
Black 82 88 170
White 508 489 997
Other 18 20 38
Hemoglobin A1c (A1C)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 625 participants 621 participants 1246 participants
9.91  (1.83) 9.83  (1.77) 9.87  (1.80)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (A1C) at Week 18
Hide Description A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥ 1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.
Arm/Group Title Sita/Met FDC Metformin
Hide Arm/Group Description:
The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Overall Number of Participants Analyzed 559 564
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-2.37
(-2.49 to -2.24)
-1.76
(-1.88 to -1.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita/Met FDC, Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment, baseline A1C
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.60
Confidence Interval 95%
-0.78 to -0.43
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With A1C < 7.0% at Week 18
Hide Description [Not Specified]
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.
Arm/Group Title Sita/Met FDC Metformin
Hide Arm/Group Description:
The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Overall Number of Participants Analyzed 559 564
Measure Type: Number
Unit of Measure: Participants
Patients with A1C <7.0% at Week 18 275 193
Patients with A1C ≥7.0% at Week 18 284 371
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita/Met FDC, Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on a test of the odds ratio = 1, comparing the odds of having A1C <7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.
Method ANCOVA
Comments Model terms: treatment, baseline A1C
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.07
Confidence Interval 95%
1.60 to 2.69
Estimation Comments This parameter estimate and 95% confidence interval correspond to the odds of having A1C <7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Hide Description FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.
Time Frame Baseline and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were treated as missing. For FAS with no data at Week 18, the last post-baseline observed measurement was carried forward to Week 18.
Arm/Group Title Sita/Met FDC Metformin
Hide Arm/Group Description:
The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Overall Number of Participants Analyzed 560 566
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-69.4
(-74.1 to -64.6)
-53.7
(-58.4 to -48.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita/Met FDC, Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment, baseline A1C
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -15.7
Confidence Interval 95%
-22.4 to -9.0
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Change From Baseline in A1C at Week 44
Hide Description A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.
Time Frame Baseline and Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients who received at least 1 dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.
Arm/Group Title Sita/Met FDC Metformin
Hide Arm/Group Description:
The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Overall Number of Participants Analyzed 560 569
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-2.25
(-2.38 to -2.12)
-1.77
(-1.89 to -1.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita/Met FDC, Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.48
Confidence Interval 95%
-0.67 to -0.30
Estimation Comments This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0) A1C.
5.Other Pre-specified Outcome
Title Number of Patients With A1C < 7.0% at Week 44
Hide Description [Not Specified]
Time Frame Week 44
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients who received at least 1dose of double-blind study therapy, had a baseline value and ≥1 post-baseline value for this outcome. Data after initiation of additional AHA were included. For FAS with no data at Week 44, the last post-baseline observed measurement was carried forward to Week 44.
Arm/Group Title Sita/Met FDC Metformin
Hide Arm/Group Description:
The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Overall Number of Participants Analyzed 560 569
Measure Type: Number
Unit of Measure: Participants
Patients with A1C <7.0% at Week 44 258 173
Patients with A1C ≥7.0% at Week 44 302 396
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita/Met FDC, Metformin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.11
Confidence Interval 95%
1.63 to 2.73
Estimation Comments This parameter estimate and 95% confidence interval correspond to the odds of having A1C <7.0% at Week 44 in the Sita/Met FDC group vs. the Metformin group, based on a logistic regression model with terms for treatment and baseline (i.e., Week 0) A1C
Time Frame Week 0 through Week 44
Adverse Event Reporting Description 1 patient in the Sita/Met FDC group and 3 patients in the Metformin group from Site 079011301, which was identified as non-compliant with some of the requirements of Good Clinical Practice. For this reason, data from all four randomized patients at this site were deemed unreliable and were excluded from the primary efficacy and safety analysis.
 
Arm/Group Title Sita/Met FDC Metformin
Hide Arm/Group Description The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated. The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
All-Cause Mortality
Sita/Met FDC Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sita/Met FDC Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   28/625 (4.48%)   38/621 (6.12%) 
Cardiac disorders     
Any Cardiac Disorders * 1  5/625 (0.80%)  6/621 (0.97%) 
Acute coronary syndrome * 1  1/625 (0.16%)  0/621 (0.00%) 
Acute myocardial infarction * 1  1/625 (0.16%)  0/621 (0.00%) 
Atrial flutter * 1  0/625 (0.00%)  1/621 (0.16%) 
Cardiac failure congestive * 1  1/625 (0.16%)  0/621 (0.00%) 
Cardio-respiratory arrest * 1  0/625 (0.00%)  1/621 (0.16%) 
Coronary artery disease * 1  1/625 (0.16%)  3/621 (0.48%) 
Myocardial infarction * 1  1/625 (0.16%)  0/621 (0.00%) 
Myocardial ischaemia * 1  0/625 (0.00%)  1/621 (0.16%) 
Gastrointestinal disorders     
Any Gastrointestinal Disorders * 1  2/625 (0.32%)  2/621 (0.32%) 
Food poisoning * 1  1/625 (0.16%)  0/621 (0.00%) 
Pancreatitis * 1  1/625 (0.16%)  0/621 (0.00%) 
Pancreatitis acute * 1  0/625 (0.00%)  1/621 (0.16%) 
Pancreatitis chronic * 1  0/625 (0.00%)  1/621 (0.16%) 
General disorders     
Any General Disorders and Administration site Conditions * 1  1/625 (0.16%)  3/621 (0.48%) 
Adverse drug reaction * 1  0/625 (0.00%)  1/621 (0.16%) 
Electrocution * 1  0/625 (0.00%)  1/621 (0.16%) 
Non-cardiac chest pain * 1  1/625 (0.16%)  1/621 (0.16%) 
Hepatobiliary disorders     
Any Hepatobiliary disorders * 1  0/625 (0.00%)  2/621 (0.32%) 
Cholecystitis * 1  0/625 (0.00%)  1/621 (0.16%) 
Cholelithiasis * 1  0/625 (0.00%)  1/621 (0.16%) 
Infections and infestations     
Any Infections and Infestations * 1  6/625 (0.96%)  6/621 (0.97%) 
Appendicitis * 1  1/625 (0.16%)  1/621 (0.16%) 
Bronchitis * 1  0/625 (0.00%)  1/621 (0.16%) 
Cellulitis * 1  1/625 (0.16%)  0/621 (0.00%) 
Enterocolitis infectious * 1  1/625 (0.16%)  0/621 (0.00%) 
Gastroenteritis * 1  1/625 (0.16%)  0/621 (0.00%) 
Gastroenteritis viral * 1  1/625 (0.16%)  1/621 (0.16%) 
Hepatitis C * 1  0/625 (0.00%)  1/621 (0.16%) 
Pneumonia streptococcal * 1  1/625 (0.16%)  0/621 (0.00%) 
Pyelonephritis acute * 1  0/625 (0.00%)  1/621 (0.16%) 
Urinary tract infection * 1  0/625 (0.00%)  1/621 (0.16%) 
Injury, poisoning and procedural complications     
Any Injury, Poisoning and Procedural Complications * 1  2/625 (0.32%)  2/621 (0.32%) 
Contusion * 1  0/625 (0.00%)  1/621 (0.16%) 
Pneumothorax traumatic * 1  1/625 (0.16%)  0/621 (0.00%) 
Rib fracture * 1  1/625 (0.16%)  1/621 (0.16%) 
Skull fractured base * 1  0/625 (0.00%)  1/621 (0.16%) 
Metabolism and nutrition disorders     
Any Metabolism and Nutrition Disorders * 1  1/625 (0.16%)  2/621 (0.32%) 
Diabetes mellitus * 1  0/625 (0.00%)  1/621 (0.16%) 
Diabetic foot * 1  1/625 (0.16%)  1/621 (0.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Any Neoplasms benign, malignant and unspecified (incl cysts and polyps) * 1  3/625 (0.48%)  5/621 (0.81%) 
Colon cancer * 1  1/625 (0.16%)  0/621 (0.00%) 
Endometrial cancer metastatic * 1  0/625 (0.00%)  1/621 (0.16%) 
Laryngeal cancer * 1  1/625 (0.16%)  0/621 (0.00%) 
Lung adenocarcinoma metastatic * 1  0/625 (0.00%)  1/621 (0.16%) 
Malignant melanoma * 1  0/625 (0.00%)  1/621 (0.16%) 
Metastatic renal cell carcinoma * 1  1/625 (0.16%)  0/621 (0.00%) 
Ovarian adenoma * 1  0/625 (0.00%)  1/621 (0.16%) 
Prostate cancer metastatic * 1  0/625 (0.00%)  1/621 (0.16%) 
Nervous system disorders     
Any Nervous System Disorders * 1  1/625 (0.16%)  5/621 (0.81%) 
Carotid artery disease * 1  0/625 (0.00%)  1/621 (0.16%) 
Cerebrovascular accident * 1  0/625 (0.00%)  2/621 (0.32%) 
Transient ischaemic attack * 1  1/625 (0.16%)  2/621 (0.32%) 
Pregnancy, puerperium and perinatal conditions     
Any Pregnancy, puerperium and perinatal conditions * 1  1/625 (0.16%)  0/621 (0.00%) 
Abortion spontaneous * 1  1/625 (0.16%)  0/621 (0.00%) 
Psychiatric disorders     
Any Psychiatric Disorders * 1  2/625 (0.32%)  3/621 (0.48%) 
Anxiety * 1  1/625 (0.16%)  0/621 (0.00%) 
Panic attack * 1  1/625 (0.16%)  0/621 (0.00%) 
Schizophrenia * 1  0/625 (0.00%)  1/621 (0.16%) 
Suicidal ideation * 1  0/625 (0.00%)  2/621 (0.32%) 
Renal and urinary disorders     
Any Renal and Urinary Disorders * 1  2/625 (0.32%)  2/621 (0.32%) 
Nephrolithiasis * 1  1/625 (0.16%)  0/621 (0.00%) 
Neurogenic bladder * 1  0/625 (0.00%)  1/621 (0.16%) 
Postrenal failure * 1  0/625 (0.00%)  1/621 (0.16%) 
Renal colic * 1  0/625 (0.00%)  1/621 (0.16%) 
Renal failure acute * 1  1/625 (0.16%)  0/621 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Any Respiratory, Thoracic and Mediastinal Disorders * 1  3/625 (0.48%)  1/621 (0.16%) 
Chronic obstructive pulmonary disease * 1  1/625 (0.16%)  0/621 (0.00%) 
Pneumonia aspiration * 1  1/625 (0.16%)  0/621 (0.00%) 
Pneumothorax * 1  0/625 (0.00%)  1/621 (0.16%) 
Pulmonary embolism * 1  1/625 (0.16%)  0/621 (0.00%) 
Respiratory distress * 1  1/625 (0.16%)  0/621 (0.00%) 
Vascular disorders     
Any Vascular Disorders * 1  2/625 (0.32%)  4/621 (0.64%) 
Aneurysm * 1  0/625 (0.00%)  1/621 (0.16%) 
Aortic aneurysm * 1  0/625 (0.00%)  1/621 (0.16%) 
Aortic stenosis * 1  1/625 (0.16%)  1/621 (0.16%) 
Peripheral arterial occlusive disease * 1  1/625 (0.16%)  0/621 (0.00%) 
Thrombophlebitis * 1  0/625 (0.00%)  1/621 (0.16%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sita/Met FDC Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   173/625 (27.68%)   185/621 (29.79%) 
Gastrointestinal disorders     
Any Gastrointestinal Disorders * 1  107/625 (17.12%)  136/621 (21.90%) 
Diarrhoea * 1  86/625 (13.76%)  112/621 (18.04%) 
Nausea * 1  37/625 (5.92%)  44/621 (7.09%) 
Infections and infestations     
Any Infections and infestations * 1  62/625 (9.92%)  57/621 (9.18%) 
Nasopharyngitis * 1  33/625 (5.28%)  26/621 (4.19%) 
Upper respiratory tract infection * 1  30/625 (4.80%)  31/621 (4.99%) 
Nervous system disorders     
Any Nervous system disorders * 1  35/625 (5.60%)  23/621 (3.70%) 
Headache * 1  35/625 (5.60%)  23/621 (3.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Site 079011301 was non-compliant with Good Clinical Practice (GCP). Data from the 4 patients at this site are included in the Participant Flow summary, but are excluded from all other summaries and analyses.
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482729    
Other Study ID Numbers: 0431A-079
MK0431A-079
2007_548
First Submitted: May 31, 2007
First Posted: June 5, 2007
Results First Submitted: December 9, 2009
Results First Posted: March 15, 2010
Last Update Posted: June 9, 2017