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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3102-016 | Other Identifier | protocol number |
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This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omarigliptin | Experimental | Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. |
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| Glimepiride | Active Comparator | Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omarigliptin | Drug |
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| Placebo to Omarigliptin |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1C at Week 54 | Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C. | Baseline and Week 54 |
| Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. | Up to Week 57 |
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue | Up to Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 54 | Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline). | Baseline and Week 54 |
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Inclusion Criteria:
Exclusion Criteria:
started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
cervical cancer
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
during the trial, including 21 days following the last dose of study drug
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28548024 | Result | Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28. |
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In total, 1197 participants at 115 clinical sites were screened and 446 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were participants not meeting the metformin inclusion criteria or meeting exclusionary laboratory values.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omarigliptin | Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. |
| FG001 | Glimepiride | Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Glimepiride | Drug | Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia. |
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| Glimepiride Placebo | Drug |
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| Metformin | Drug | Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial. |
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| Insulin Glargine | Drug | Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label. |
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| Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54 |
The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54. |
| Week 54 |
| Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue | Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required). | Up to Week 54 |
| Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue | Baseline and Week 54 |
| Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54 | The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54. | Week 54 |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Omarigliptin | Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. |
| BG001 | Glimepiride | Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Hemoglobin A1C | For both the Omarigliptin and Glimepiride groups n=375 | Mean | Standard Deviation | A1C (%) |
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| Fasting Plamsa Glucose (FPG) | For both the Omarigliptin and Glimepiride groups n=375 | Mean | Standard Deviation | mg/dL |
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| Body Weight | For both the Omarigliptin and Glimepiride groups n=375 | Mean | Standard Deviation | kg |
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| 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 at Week 54 | Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C. | The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. | Posted | Least Squares Mean | 95% Confidence Interval | A1C (%) | Baseline and Week 54 |
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| Primary | Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. | All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. | Posted | Number | Percentage of participants | Up to Week 57 |
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| Primary | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue | The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. | Posted | Number | Percentage of participants | Up to Week 54 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 54 | Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline). | The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 54 |
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| Secondary | Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54 | The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54. | The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 54 |
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| Secondary | Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue | Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required). | The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. | Posted | Number | Percentage of participants | Up to Week 54 |
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| Secondary | Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue | The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline and Week 54 |
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| Secondary | Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54 | The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54. | The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 54 |
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Up to Week 57
Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omarigliptin | Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks. | 24 | 375 | 43 | 375 | ||
| EG001 | Glimepiride | Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. | 18 | 375 | 125 | 375 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Rectal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Impaired healing | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Carbuncle | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Cholecystitis infective | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Pulmonary sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Septic arthritis staphylococcal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Dumping syndrome | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Lumbar radiculopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Trigeminal neuralgia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| 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 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C587539 | 2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine |
| C057619 | glimepiride |
| D008687 | Metformin |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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