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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000004047 | Other Identifier | UMIN |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental |
| |
| Glimepiride | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at 52 W | Baseline and 52 W | |
| Number of Participants With Hypoglycaemia | From baseline to 52 W |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Achieving HbA1c < 6.9 % | 52 W | |
| Change From Baseline in HOMA-β at 52 W | β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasuo Terauchi, M.D., Ph.D. | Yokohama City University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan Association for Diabetes Education and Care | Chiyoda-Ku | Tokyo | 102-0083 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28294488 | Derived | Terauchi Y, Yamada Y, Ishida H, Ohsugi M, Kitaoka M, Satoh J, Yabe D, Shihara N, Seino Y. Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged >/= 60 years (START-J trial). Diabetes Obes Metab. 2017 Aug;19(8):1188-1192. doi: 10.1111/dom.12933. Epub 2017 Apr 12. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50). |
| FG001 | Glimepiride | Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis set of evaluation for efficacy ; Per Protocol Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50). |
| BG001 | Glimepiride | Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg |
| 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 52 W | Analysis set of evaluation for efficacy; Per Protocol Set. | Posted | Least Squares Mean | 95% Confidence Interval | percent | Baseline and 52 W |
|
|
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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 | Sitagliptin | Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal abscess | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Yasuo Terauchi | Japan Association for Diabetes Education and Care | +81-3-3514-1721 | terauchi-tky@umin.ac.jp |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Glimepiride | Drug | Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg |
|
| Baseline and 52 W |
| Change From Baseline in Insulin/Proinsulin Ratio at 52 W | Baseline and 52 W |
| Change From Baseline in Body Weight at 52 W | Baseline and 52 W |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Nonparticipation in Extension Study |
|
| Did not receive study drug |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HbA1c | Mean | Standard Deviation | percent |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| eGFR | Mean | Standard Deviation | mL/min/1.73m^2 |
|
| Body weight | Mean | Standard Deviation | kg |
|
| HOMA-β | Mean | Standard Deviation | percent |
|
| Insulin/Proinsulin Ratio | Mean | Standard Deviation | ratio |
|
| Participants |
|
|
|
| Primary | Number of Participants With Hypoglycaemia | Analysis set of evaluation for safety. | Posted | Count of Participants | Participants | From baseline to 52 W |
|
|
|
|
| Secondary | The Number of Participants Achieving HbA1c < 6.9 % | Analysis set of evaluation for efficacy; Per Protocol Set Some participants were not completed to 52 W. | Posted | Count of Participants | Participants | 52 W |
|
|
|
|
| Secondary | Change From Baseline in HOMA-β at 52 W | β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5] | Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement. | Posted | Mean | Standard Deviation | percent | Baseline and 52 W |
|
|
|
|
| Secondary | Change From Baseline in Insulin/Proinsulin Ratio at 52 W | Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement. | Posted | Mean | Standard Deviation | ratio | Baseline and 52 W |
|
|
|
|
| Secondary | Change From Baseline in Body Weight at 52 W | Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement. | Posted | Mean | Standard Deviation | kg | Baseline and 52 W |
|
|
|
|
| 13 |
| 148 |
| 33 |
| 148 |
| EG001 | Glimepiride | Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg | 3 | 143 | 31 | 143 |
| Infectious enteritis | Infections and infestations |
|
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Hemorrhagic diathesis | Blood and lymphatic system disorders |
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| Cerebral infarction | Nervous system disorders |
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| Hyphema | Eye disorders |
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| Acute myocardial infarction | Cardiac disorders |
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| Complete atrioventricular block | Cardiac disorders |
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| Takotsubo cardiomyopathy | Cardiac disorders |
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| Colon polyp | Gastrointestinal disorders |
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| Dermatitis exfoliative | Skin and subcutaneous tissue disorders |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders |
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| Trismus | Musculoskeletal and connective tissue disorders |
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| Renal failure | Renal and urinary disorders |
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| Death | General disorders |
|
| Globe rupture | Injury, poisoning and procedural complications |
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| Radius fracture | Injury, poisoning and procedural complications |
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| Appendicitis | Infections and infestations |
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| Bronchitis | Infections and infestations |
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| Cystitis | Infections and infestations |
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| Herpes zoster | Infections and infestations |
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| Nasopharyngitis | Infections and infestations |
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| Pharyngitis | Infections and infestations |
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| Helicobacter infection | Infections and infestations |
|
| Bile ｄuct ｃancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Colon ｃancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Polycythemia vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Anemia | Blood and lymphatic system disorders |
|
| Mediastinal lymphadenopathy | Blood and lymphatic system disorders |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders |
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| Hyperuricemia | Metabolism and nutrition disorders |
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| Hypoglycemia | Metabolism and nutrition disorders |
|
| Loss of appetite | Metabolism and nutrition disorders |
|
| Depression | Psychiatric disorders |
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| Insomnia | Psychiatric disorders |
|
| Cerebral infarction | Nervous system disorders |
|
| Dizziness | Nervous system disorders |
|
| Hypoesthesia | Nervous system disorders |
|
| Loss of consciousness | Nervous system disorders |
|
| Sciatica | Nervous system disorders |
|
| Allergic conjunctivitis | Eye disorders |
|
| Pterygium | Eye disorders |
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| Retinal hemorrhages | Eye disorders |
|
| Vision blurred | Eye disorders |
|
| Tinnitus | Ear and labyrinth disorders |
|
| Atrial fibrillation | Cardiac disorders |
|
| Heart failure | Cardiac disorders |
|
| Myocardial ischemia | Cardiac disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders |
|
| Abdominal pain upper | Gastrointestinal disorders |
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| Constipation | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
|
| Gastric ulcer | Gastrointestinal disorders |
|
| Erosive gastritis | Gastrointestinal disorders |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders |
|
| Hemorrhoid | Gastrointestinal disorders |
|
| Stomatitis | Gastrointestinal disorders |
|
| Choledocholith | Hepatobiliary disorders |
|
| Cholelithiasis | Hepatobiliary disorders |
|
| Liver Cyst | Hepatobiliary disorders |
|
| Hepatic function abnormal | Hepatobiliary disorders |
|
| Eczema | Skin and subcutaneous tissue disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
|
| Seborrheic dermatitis | Skin and subcutaneous tissue disorders |
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| Hives | Skin and subcutaneous tissue disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders |
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| Spondylosis deformans | Musculoskeletal and connective tissue disorders |
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| Hygroma | Musculoskeletal and connective tissue disorders |
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| Tenovaginitis | Musculoskeletal and connective tissue disorders |
|
| Disc protrusion | Musculoskeletal and connective tissue disorders |
|
| Ureteral calculus | Renal and urinary disorders |
|
| Face edema | General disorders |
|
| Malaise | General disorders |
|
| Fever | General disorders |
|
| Blood pressure increased | Investigations |
|
| Blood uric acid increased | Investigations |
|
| Platelet count decreased | Investigations |
|
| T-wave abnormality | Investigations |
|
| Injury | Injury, poisoning and procedural complications |
|
| Sprained ligament | Injury, poisoning and procedural complications |
|
| Wrist join fraction | Injury, poisoning and procedural complications |
|
| Ureteral stone removal | Surgical and medical procedures |
|
| Dental care | Surgical and medical procedures |
|
| Cataract operation | Surgical and medical procedures |
|
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |