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Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(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: NCT00086515
Recruitment Status : Completed
First Posted : July 5, 2004
Results First Posted : December 17, 2010
Last Update Posted : May 5, 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, Type II
Interventions Drug: Sitagliptin (MK0431)
Drug: Placebo/Glipizide 5 mg
Drug: Metformin
Drug: Pioglitazone
Enrollment 701
Recruitment Details Primary therapy Period: 13-Jul-2004 through 02-Feb-2007 (for the 2-year Phase A and B periods); 100 study centers worldwide. (46 sites in the United States, 25 sites in 11 countries in Europe, and 29 sites in 13 countries in the rest of the world).
Pre-assignment Details Patients 18-78 years of age with type 2 diabetes mellitus with inadequate glycemic control (hemoglobin A1C [A1C] ≥7% and ≤10%) on stable doses of metformin (≥1500 mg/day) were eligible to enter the 104-week study.
Arm/Group Title Sitagliptin 100 mg Placebo / Glipizide 5 mg
Hide Arm/Group Description The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.

The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral

tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase

B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with

oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,

in a blinded fashion, to a maximum dose of 15 mg/day.

Period Title: Phase A (Weeks 0-24)
Started 464 237
Completed 415 192
Not Completed 49 45
Reason Not Completed
Adverse Event             17             9
Lack of Efficacy             7             13
Lost to Follow-up             4             5
Protocol Violation             3             1
Withdrawal by Subject             10             10
Patient Moved             2             3
Protocol-Spec lab discon criteria             4             3
Poor compliance             1             0
Patient needed prohibited treatment             0             1
Personal Circumstance             1             0
Period Title: Phase A to Phase B Transition Period
Started 415 192
Completed 391 164
Not Completed 24 28
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             2             2
Withdrawal by Subject             1             0
Protocol Violation             0             1
Patient received Phase A rescue therapy             16             23
Protocol-Spec lab discon criteria             1             1
Poor compliance             1             0
Patient needed prohibited treatment             1             0
Period Title: Phase B (Weeks 24-104)
Started 391 164
Completed 201 109
Not Completed 190 55
Reason Not Completed
Adverse Event             16             10
Lack of Efficacy             94             19
Lost to Follow-up             13             4
Physician Decision             3             0
Protocol Violation             1             0
Withdrawal by Subject             15             5
Patient Moved             2             2
Protocol-Specific discontinuation             5             3
Protocol-Specific lab discon criteria             36             10
Patient Died             3             1
Patient needed prohibited treatment             0             1
Personal Circumstance             1             0
Discontinued in error             1             0
Arm/Group Title Sitagliptin 100 mg Placebo / Glipizide 5 mg Total
Hide Arm/Group Description The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.

The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral

tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase

B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with

oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,

in a blinded fashion, to a maximum dose of 15 mg/day.

Total of all reporting groups
Overall Number of Baseline Participants 464 237 701
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 464 participants 237 participants 701 participants
54.4  (10.4) 54.7  (9.7) 54.5  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 464 participants 237 participants 701 participants
Female
205
  44.2%
96
  40.5%
301
  42.9%
Male
259
  55.8%
141
  59.5%
400
  57.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 464 participants 237 participants 701 participants
White 293 159 452
Black 31 14 45
Hispanic 72 28 100
Asian 49 26 75
Other 19 10 29
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 464 participants 237 participants 701 participants
170.2  (40.2) 174.1  (42.0) 171.5  (41.3)
Hemoglobin A1C (A1C)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 464 participants 237 participants 701 participants
8.0  (0.8) 8.0  (0.8) 8.0  (0.8)
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1C (A1C) at Week 24
Hide Description

A1C is measured as a percent. Thus, this change from

baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg Placebo / Glipizide 5 mg
Hide Arm/Group Description:
The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.

The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral

tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase

B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with

oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,

in a blinded fashion, to a maximum dose of 15 mg/day.

Overall Number of Participants Analyzed 453 224
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.67
(-0.77 to -0.57)
-0.02
(-0.15 to 0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo / Glipizide 5 mg
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, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline A1C
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-0.77 to -0.53
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description

Change from baseline at Week 24 is defined as FPG at

Week 24 minus FPG at Week 0.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg Placebo / Glipizide 5 mg
Hide Arm/Group Description:
The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.

The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral

tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase

B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with

oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,

in a blinded fashion, to a maximum dose of 15 mg/day.

Overall Number of Participants Analyzed 454 226
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-16.9
(-21.5 to -12.3)
8.5
(2.9 to 14.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo / Glipizide 5 mg
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, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline FPG
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.4
Confidence Interval (2-Sided) 95%
-31.0 to -19.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24
Hide Description Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg Placebo / Glipizide 5 mg
Hide Arm/Group Description:
The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.

The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral

tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase

B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with

oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,

in a blinded fashion, to a maximum dose of 15 mg/day.

Overall Number of Participants Analyzed 387 182
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-62.0
(-70.2 to -53.8)
-11.4
(-21.7 to -1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo / Glipizide 5 mg
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, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline 2-hour PMG
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -50.6
Confidence Interval (2-Sided) 95%
-60.5 to -40.8
Estimation Comments [Not Specified]
Time Frame Weeks 0-104
Adverse Event Reporting Description Patients received rescue medication if they met specific glycemic goals. Serious Adverse Events (SAEs) include events that occurred either before or after receiving rescue medication. Other Adverse Events (AEs) only includes those AEs that occurred prior to a patient receiving rescue medication.
 
Arm/Group Title Sitagliptin 100 mg Placebo / Glipizide 5 mg
Hide Arm/Group Description The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.

The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral

tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase

B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with

oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,

in a blinded fashion, to a maximum dose of 15 mg/day.

All-Cause Mortality
Sitagliptin 100 mg Placebo / Glipizide 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin 100 mg Placebo / Glipizide 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   54/464 (11.64%)   21/237 (8.86%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  1/464 (0.22%)  1/237 (0.42%) 
Angina Pectoris * 1  1/464 (0.22%)  0/237 (0.00%) 
Angina Unstable * 1  1/464 (0.22%)  0/237 (0.00%) 
Atrial Fibrillation * 1  0/464 (0.00%)  1/237 (0.42%) 
Cardiac Failure * 1  1/464 (0.22%)  0/237 (0.00%) 
Coronary Artery Disease * 1  1/464 (0.22%)  1/237 (0.42%) 
Myocardial Infarction * 1  0/464 (0.00%)  1/237 (0.42%) 
Myocardial Ischaemia * 1  0/464 (0.00%)  1/237 (0.42%) 
Tachyarrhythmia * 1  1/464 (0.22%)  0/237 (0.00%) 
Eye disorders     
Cataract * 1  1/464 (0.22%)  0/237 (0.00%) 
Papilloedema * 1  1/464 (0.22%)  0/237 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  2/464 (0.43%)  0/237 (0.00%) 
Abdominal Strangulated Hernia * 1  1/464 (0.22%)  0/237 (0.00%) 
Duodenal Ulcer Haemorrhage * 1  1/464 (0.22%)  0/237 (0.00%) 
Inguinal Hernia * 1  1/464 (0.22%)  0/237 (0.00%) 
Melaena * 1  1/464 (0.22%)  0/237 (0.00%) 
Reflux Oesophagitis * 1  1/464 (0.22%)  0/237 (0.00%) 
Small Intestinal Obstruction * 1  1/464 (0.22%)  0/237 (0.00%) 
Upper Gastrointestinal Haemorrhage * 1  1/464 (0.22%)  0/237 (0.00%) 
General disorders     
Chest Pain * 1  1/464 (0.22%)  0/237 (0.00%) 
Death * 1  2/464 (0.43%)  0/237 (0.00%) 
Hernia * 1  1/464 (0.22%)  0/237 (0.00%) 
Non-Cardiac Chest Pain * 1  1/464 (0.22%)  3/237 (1.27%) 
Hepatobiliary disorders     
Biliary Colic * 1  1/464 (0.22%)  0/237 (0.00%) 
Cholangitis * 1  1/464 (0.22%)  0/237 (0.00%) 
Cholecystitis * 1  1/464 (0.22%)  0/237 (0.00%) 
Cholelithiasis * 1  1/464 (0.22%)  0/237 (0.00%) 
Hepatic Failure * 1  0/464 (0.00%)  1/237 (0.42%) 
Infections and infestations     
Abdominal Wall Infection * 1  1/464 (0.22%)  0/237 (0.00%) 
Bronchitis Acute * 1  1/464 (0.22%)  0/237 (0.00%) 
Cellulitis * 1  1/464 (0.22%)  0/237 (0.00%) 
Gastroenteritis * 1  2/464 (0.43%)  0/237 (0.00%) 
Helicobacter Gastritis * 1  0/464 (0.00%)  1/237 (0.42%) 
Infected Epidermal Cyst * 1  1/464 (0.22%)  0/237 (0.00%) 
Liver Abscess * 1  0/464 (0.00%)  1/237 (0.42%) 
Lobar Pneumonia * 1  1/464 (0.22%)  0/237 (0.00%) 
Meningitis Bacterial * 1  1/464 (0.22%)  0/237 (0.00%) 
Perirectal Abscess * 1  1/464 (0.22%)  0/237 (0.00%) 
Pneumonia * 1  1/464 (0.22%)  0/237 (0.00%) 
Pneumonia Primary Atypical * 1  0/464 (0.00%)  1/237 (0.42%) 
Postoperative Wound Infection * 1  1/464 (0.22%)  0/237 (0.00%) 
Pyelonephritis * 1  1/464 (0.22%)  0/237 (0.00%) 
Upper Respiratory Tract Infection * 1  1/464 (0.22%)  0/237 (0.00%) 
Urinary Tract Infection * 1  1/464 (0.22%)  0/237 (0.00%) 
Injury, poisoning and procedural complications     
Gun Shot Wound * 1  0/464 (0.00%)  1/237 (0.42%) 
Head Injury * 1  0/464 (0.00%)  1/237 (0.42%) 
Joint Injury * 1  1/464 (0.22%)  0/237 (0.00%) 
Polytraumatism * 1  2/464 (0.43%)  0/237 (0.00%) 
Post Procedural Haemorrhage * 1  1/464 (0.22%)  0/237 (0.00%) 
Tendon Rupture * 1  1/464 (0.22%)  1/237 (0.42%) 
Traumatic Fracture * 1  0/464 (0.00%)  1/237 (0.42%) 
Investigations     
Blood Creatine Phosphokinase Increased * 1  1/464 (0.22%)  0/237 (0.00%) 
Blood Glucose Increased * 1  1/464 (0.22%)  0/237 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia * 1  1/464 (0.22%)  1/237 (0.42%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  2/464 (0.43%)  0/237 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-Cell Lymphoma * 1  1/464 (0.22%)  0/237 (0.00%) 
Basal Cell Carcinoma * 1  1/464 (0.22%)  0/237 (0.00%) 
Bladder Cancer * 1  1/464 (0.22%)  0/237 (0.00%) 
Breast Cancer * 1  1/464 (0.22%)  0/237 (0.00%) 
Clear Cell Carcinoma Of The Kidney * 1  1/464 (0.22%)  0/237 (0.00%) 
Follicular Thyroid Cancer * 1  1/464 (0.22%)  0/237 (0.00%) 
Hepatic Neoplasm Malignant * 1  1/464 (0.22%)  0/237 (0.00%) 
Lung Neoplasm Malignant * 1  0/464 (0.00%)  1/237 (0.42%) 
Ovarian Adenoma * 1  1/464 (0.22%)  0/237 (0.00%) 
Pancreatic Carcinoma * 1  1/464 (0.22%)  0/237 (0.00%) 
Papillary Thyroid Cancer * 1  1/464 (0.22%)  0/237 (0.00%) 
Squamous Cell Carcinoma Of Skin * 1  1/464 (0.22%)  0/237 (0.00%) 
Nervous system disorders     
Carotid Artery Stenosis * 1  1/464 (0.22%)  0/237 (0.00%) 
Cerebrovascular Accident * 1  1/464 (0.22%)  0/237 (0.00%) 
Ischaemic Stroke * 1  1/464 (0.22%)  0/237 (0.00%) 
Loss Of Consciousness * 1  0/464 (0.00%)  1/237 (0.42%) 
Subarachnoid Haemorrhage * 1  1/464 (0.22%)  0/237 (0.00%) 
Syncope * 1  1/464 (0.22%)  0/237 (0.00%) 
Transient Ischaemic Attack * 1  0/464 (0.00%)  1/237 (0.42%) 
Psychiatric disorders     
Depression * 1  1/464 (0.22%)  0/237 (0.00%) 
Renal and urinary disorders     
Calculus Ureteric * 1  1/464 (0.22%)  0/237 (0.00%) 
Nephrolithiasis * 1  0/464 (0.00%)  1/237 (0.42%) 
Nocturia * 1  1/464 (0.22%)  0/237 (0.00%) 
Renal Colic * 1  1/464 (0.22%)  0/237 (0.00%) 
Renal Failure * 1  0/464 (0.00%)  1/237 (0.42%) 
Reproductive system and breast disorders     
Pelvic Haematoma * 1  1/464 (0.22%)  0/237 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure * 1  1/464 (0.22%)  0/237 (0.00%) 
Pulmonary Embolism * 1  1/464 (0.22%)  0/237 (0.00%) 
Tracheal Stenosis * 1  1/464 (0.22%)  0/237 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/464 (0.00%)  1/237 (0.42%) 
Surgical and medical procedures     
Finger Amputation * 1  1/464 (0.22%)  0/237 (0.00%) 
Vascular disorders     
Arteriosclerosis * 1  1/464 (0.22%)  0/237 (0.00%) 
Hypertension * 1  1/464 (0.22%)  0/237 (0.00%) 
Leriche Syndrome * 1  1/464 (0.22%)  0/237 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sitagliptin 100 mg Placebo / Glipizide 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   210/464 (45.26%)   124/237 (52.32%) 
Gastrointestinal disorders     
Diarrhoea * 1  28/464 (6.03%)  11/237 (4.64%) 
Infections and infestations     
Bronchitis * 1  26/464 (5.60%)  12/237 (5.06%) 
Influenza * 1  37/464 (7.97%)  20/237 (8.44%) 
Nasopharyngitis * 1  41/464 (8.84%)  16/237 (6.75%) 
Upper Respiratory Tract Infection * 1  49/464 (10.56%)  29/237 (12.24%) 
Urinary Tract Infection * 1  22/464 (4.74%)  13/237 (5.49%) 
Investigations     
Blood Glucose Increased * 1  8/464 (1.72%)  14/237 (5.91%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  17/464 (3.66%)  41/237 (17.30%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  33/464 (7.11%)  20/237 (8.44%) 
Nervous system disorders     
Headache * 1  20/464 (4.31%)  13/237 (5.49%) 
Vascular disorders     
Hypertension * 1  29/464 (6.25%)  18/237 (7.59%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
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
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: NCT00086515     History of Changes
Other Study ID Numbers: 0431-020
Formally-B0604T2DMT
2006_411
First Submitted: July 2, 2004
First Posted: July 5, 2004
Results First Submitted: November 19, 2010
Results First Posted: December 17, 2010
Last Update Posted: May 5, 2017