Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Formally-B0604T2DMT | |||
| 2006_411 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Not provided
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 100 mg | Experimental | 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. |
|
| Placebo / Glipizide 5 mg | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin (MK0431) | Drug | Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (A1C) at Week 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Change from baseline at Week 24 is defined as FPG at Week 24 minus FPG at Week 0. | Baseline and Week 24 |
| Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17130197 | Background | Charbonnel B, Karasik A, Liu J, Wu M, Meininger G; Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006 Dec;29(12):2638-43. doi: 10.2337/dc06-0706. | |
| 18476982 |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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.
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg | 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. |
| FG001 | Placebo / Glipizide 5 mg | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase A (Weeks 0-24) |
|
| |||||||||||||||||||||
| Phase A to Phase B Transition Period |
| ||||||||||||||||||||||
| Phase B (Weeks 24-104) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1C (A1C) at Week 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 24 |
|
Weeks 0-104
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin 100 mg | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D005913 | Glipizide |
| D008687 | Metformin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo/Glipizide 5 mg | Drug | Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104) |
|
| Metformin | Drug | Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104) |
|
| Pioglitazone | Drug | Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24) |
|
|
Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
| Baseline and Week 24 |
| Xu L, Man CD, Charbonnel B, Meninger G, Davies MJ, Williams-Herman D, Cobelli C, Stein PP. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on beta-cell function in patients with type 2 diabetes: a model-based approach. Diabetes Obes Metab. 2008 Dec;10(12):1212-20. doi: 10.1111/j.1463-1326.2008.00887.x. Epub 2008 May 12. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient Moved |
|
| Protocol-Spec lab discon criteria |
|
| Poor compliance |
|
| Patient needed prohibited treatment |
|
| Personal Circumstance |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Placebo / Glipizide 5 mg | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1C (A1C) | Mean | Standard Deviation | Percent |
|
| OG001 | Placebo / Glipizide 5 mg | 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. |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Change from baseline at Week 24 is defined as FPG at Week 24 minus FPG at Week 0. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 | Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
|
| 54 |
| 464 |
| 210 |
| 464 |
| EG001 | Placebo / Glipizide 5 mg | 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. | 21 | 237 | 124 | 237 |
| Angina Pectoris | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Papilloedema | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Reflux Oesophagitis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Death | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Hernia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Biliary Colic | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Abdominal Wall Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Bronchitis Acute | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Helicobacter Gastritis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Infected Epidermal Cyst | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Liver Abscess | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Meningitis Bacterial | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Perirectal Abscess | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Pneumonia Primary Atypical | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Postoperative Wound Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Gun Shot Wound | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
|
| Polytraumatism | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
|
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
|
| Traumatic Fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Clear Cell Carcinoma Of The Kidney | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Follicular Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Ovarian Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Ischaemic Stroke | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Loss Of Consciousness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Calculus Ureteric | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Pelvic Haematoma | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Tracheal Stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Finger Amputation | Surgical and medical procedures | MedDRA (9.1) | Non-systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Leriche Syndrome | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
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.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |