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| ID | Type | Description | Link |
|---|---|---|---|
| MK0431-024 | |||
| 2004_049 |
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The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
The duration of treatment is 104 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 100 mg | Experimental | Sitagliptin 100 mg oral tablets of sitagliptin once daily. |
|
| Glipizide | Active Comparator | Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin (MK0431) | Drug | Sitagliptin 100 mg oral tablets of sitagliptin once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 52 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 104 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and Week 104 |
| Change From Baseline in Body Weight at Week 52 |
Not provided
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17300595 | Background | Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x. | |
| 25633134 |
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Not provided
Participants 18-78 years of age with type 2 diabetes mellitus (T2DM) and inadequate glycemic control (Hemoglobin A1c >6.5% and < 10%) on metformin at a dose of >1500mg/day.
Phase III
First Patient In: 26-Oct-2004; Last Patient Last Visit: 17-May-2007; 173 medical clinics worldwide.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily. |
| FG001 | Glipizide | The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 ( Week 0 to Week 52) |
|
| |||||||||||||||||||||
| Year 2 (Week 0 to Week 104) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily. |
| BG001 | Glipizide |
| 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 HbA1c at Week 52 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent. | The per protocol population required that a participant had measurements both at baseline and at Week 52, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 52 |
|
Not provided
Not provided
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 data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| 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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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Not provided
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| Comparator: glipizide | Drug | Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control. |
|
|
Change from baseline at Week 52 is defined as Week 52 minus Week 0.
| Baseline and Week 52 |
| Change From Baseline in Body Weight at Week 104 | Change from baseline at Week 104 is defined as Week 104 minus Week 0. | Baseline and Week 104 |
| Hypoglycemic Events at Week 52 | Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia. | Baseline to Week 52 |
| Hypoglycemic Events at Week 104 | Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia. | Baseline to Week 104 |
| Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 | An adverse experience (AE) 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. | Baseline to Week 104 |
| Number of Participants With Serious CAEs at Week 104 | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. | Baseline to Week 104 |
| Number of Participants With Drug-related CAEs at Week 104 | Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs. | Baseline to Week 104 |
| Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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. | Baseline to Week 104 |
| Number of Participants With Serious LAEs at Week 104 | Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. | Baseline to Week 104 |
| Number of Participants With Drug-related LAEs at Week 104 | Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs. | Baseline to Week 104 |
| Derived |
| Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30. |
| 21477878 | Derived | Seck TL, Engel SS, Williams-Herman DE, Sisk CM, Golm GT, Wang H, Kaufman KD, Goldstein BJ. Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizide. Diabetes Res Clin Pract. 2011 Jul;93(1):e15-7. doi: 10.1016/j.diabres.2011.03.006. Epub 2011 Apr 8. |
| 20456211 | Derived | Seck T, Nauck M, Sheng D, Sunga S, Davies MJ, Stein PP, Kaufman KD, Amatruda JM; Sitagliptin Study 024 Group. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract. 2010 Apr;64(5):562-76. doi: 10.1111/j.1742-1241.2010.02353.x. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Protocol Specified Discontinuation |
|
| Patient Moved |
|
| Withdrawal by Subject |
|
| Site Terminated |
|
| Other |
|
| NOT COMPLETED |
|
|
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percent |
|
| Glipizide |
The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control. |
|
|
| Secondary | Change From Baseline in HbA1c at Week 104 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent. | The per protocol population required that a participant had measurements both at baseline and at Week 104, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 104 |
|
|
|
| Secondary | Change From Baseline in Body Weight at Week 52 | Change from baseline at Week 52 is defined as Week 52 minus Week 0. | The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Kilograms | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in Body Weight at Week 104 | Change from baseline at Week 104 is defined as Week 104 minus Week 0. | The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Kilograms | Baseline and Week 104 |
|
|
|
| Secondary | Hypoglycemic Events at Week 52 | Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia. | All randomized participants who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 52 |
|
|
|
| Secondary | Hypoglycemic Events at Week 104 | Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia. | All randomized participants who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 104 |
|
|
|
| Secondary | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 | An adverse experience (AE) 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. | All randomized participants who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 104 |
|
|
|
| Secondary | Number of Participants With Serious CAEs at Week 104 | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. | All randomized participants who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 104 |
|
|
|
| Secondary | Number of Participants With Drug-related CAEs at Week 104 | Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs. | All randomized participants who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 104 |
|
|
|
| Secondary | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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. | All randomized participants who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 104 |
|
|
|
| Secondary | Number of Participants With Serious LAEs at Week 104 | Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. | All randomized participants who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 104 |
|
|
|
| Secondary | Number of Participants With Drug-related LAEs at Week 104 | Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs. | All randomized participants who received at least 1 dose of the double-blind study therapy. | Posted | Number | Participants | Baseline to Week 104 |
|
|
|
| 64 |
| 588 |
| 318 |
| 588 |
| EG001 | Glipizide | The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control. | 73 | 584 | 374 | 584 |
| Acute Myocardial Infarction | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Coronary Artery Occlusion | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Coronary Artery Stenosis | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hypertensive Heart Disease | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Sick Sinus Syndrome | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Sudden Hearing Loss | Ear and labyrinth disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Macular Hole | Eye disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Abdominal Hernia | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Anal Fistula | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Rectal Polyp | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Splenic Artery Aneurysm | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Umbilical Hernia | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Polyserositis | General disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Sudden Cardiac Death | General disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Bile Duct Stone | Hepatobiliary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Cholecystitis Chronic | Hepatobiliary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hydrocholecystis | Hepatobiliary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Abdominal Wall Abscess | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Arthritis Bacterial | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Carbuncle | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Dengue Fever | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Diabetic Foot Infection | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Helicobacter Infection | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Localised Infection | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Pneumonia Streptococcal | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Postoperative Wound Infection | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Burns Third Degree | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Medical Device Complication | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Meniscus Lesion | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Multiple Injuries | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Postoperative Thrombosis | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Procedural Complication | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Radius Fracture | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Tendon Injury | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Intraocular Pressure Increased | Investigations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Diabetic Foot | Metabolism and nutrition disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Muscle Haemorrhage | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Astrocytoma Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Carcinoid Tumour Of The Small Bowel | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Diffuse Large B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hepatic Neoplasm Malignant Non-Resectable | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Metastases To Bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Oesophageal Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Renal Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Renal Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Guillain-Barre Syndrome | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Loss Of Consciousness | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Lumbar Radiculopathy | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Completed Suicide | Psychiatric disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Calculus Ureteric | Renal and urinary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Renal Colic | Renal and urinary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Renal Mass | Renal and urinary disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Vaginal Prolapse | Reproductive system and breast disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Pickwickian Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Extremity Necrosis | Vascular disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Iliac Artery Stenosis | Vascular disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Peripheral Artery Aneurysm | Vascular disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Venous Insufficiency | Vascular disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRa Version 10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRa Version 10.0 | 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 |
| Participants with no Hypoglycemic AEs |
|
| Participants with no Hypoglycemic AEs |
|