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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_550 | Other Identifier | Merck Study Number |
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The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 25 mg | Experimental |
| |
| Glipizide 2.5 mg - 20 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | 25 mg (one 25-mg tablet) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment | Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only. | Baseline / Week 54 |
| Number of Participants With Clinical Adverse Events | Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy. | 54 Week Treatment Period + 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Symptomatic Hypoglycemic Adverse Events | A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level. | 54 Week Treatment Period + 28 days |
| Change From Baseline in Fasting Plasma Glucose (FPG) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23352379 | Result | Arjona Ferreira JC, Corry D, Mogensen CE, Sloan L, Xu L, Golm GT, Gonzalez EJ, Davies MJ, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kidney Dis. 2013 Apr;61(4):579-87. doi: 10.1053/j.ajkd.2012.11.043. Epub 2013 Jan 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 25 mg | One 25 mg tablet once daily for 54 weeks |
| FG001 | Glipizide 2.5 mg - 20 mg | Between 2.5 mg - 20 mg daily for 54 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 25 mg | One 25 mg tablet once daily for 54 weeks |
| BG001 | Glipizide 2.5 mg - 20 mg | Between 2.5 mg - 20 mg daily for 54 weeks |
| 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 After Sitagliptin Treatment | Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only. | Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values. | Posted | Mean | Standard Deviation | Percent hemoglobin A1c | Baseline / Week 54 |
|
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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 25 mg | One 25 mg tablet once daily for 54 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) |
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| 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 |
| D007676 | Kidney Failure, Chronic |
| 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 |
| D005913 | Glipizide |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Glipizide | Drug | 2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg |
|
|
Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks. |
| Baseline / Week 54 |
| Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment | Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. | Baseline / Week 54 |
| Protocol Violation |
|
| Excluded Medication |
|
| Scheduled Kidney Transplant |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Symptomatic Hypoglycemic Adverse Events | A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level. | All randomized participants. | Posted | Number | Participants | 54 Week Treatment Period + 28 days |
|
|
|
|
| Primary | Number of Participants With Clinical Adverse Events | Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy. | All randomized participants. | Posted | Number | Participants | 54 Week Treatment Period + 28 days |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks. | Randomized participants. Numbers analyzed excluded participants with no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values. | Posted | Mean | Standard Deviation | mg/dL | Baseline / Week 54 |
|
|
|
|
| Secondary | Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment | Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. | Randomized participants. Numbers analyzed excluded participants with either no baseline or no post-baseline measurements. The last observation carried forward (LOCF) method was used to impute missing values. | Posted | Least Squares Mean | 95% Confidence Interval | Percent hemoglobin A1c | Baseline / Week 54 |
|
|
|
|
| 23 |
| 64 |
| 33 |
| 64 |
| EG001 | Glipizide 2.5 mg - 20 mg | Between 2.5 mg - 20 mg daily for 54 weeks | 22 | 65 | 37 | 65 |
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.1) |
|
| Angina pectoris | Cardiac disorders | MedDRA (13.1) |
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| Bradycardia | Cardiac disorders | MedDRA (13.1) |
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| Cardiac arrest | Cardiac disorders | MedDRA (13.1) |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (13.1) |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA (13.1) |
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| Coronary artery stenosis | Cardiac disorders | MedDRA (13.1) |
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| Left ventricular dysfunstion | Cardiac disorders | MedDRA (13.1) |
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| Myocardial infarction | Cardiac disorders | MedDRA (13.1) |
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| Ventricular fibrillation | Cardiac disorders | MedDRA (13.1) |
|
| Abdominal adhesions | Gastrointestinal disorders | MedDRA (13.1) |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (13.1) |
|
| Enteritis | Gastrointestinal disorders | MedDRA (13.1) |
|
| Gastritis | Gastrointestinal disorders | MedDRA (13.1) |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA (13.1) |
|
| Peritonitis | Gastrointestinal disorders | MedDRA (13.1) |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (13.1) |
|
| Device malfunction | General disorders | MedDRA (13.1) |
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| Device occlusion | General disorders | MedDRA (13.1) |
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| Medical device complication | General disorders | MedDRA (13.1) |
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| Pyrexia | General disorders | MedDRA (13.1) |
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| Abdominal sepsis | Infections and infestations | MedDRA (13.1) |
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| Arteriovenous fistula site infection | Infections and infestations | MedDRA (13.1) |
|
| Bronchopneumonia | Infections and infestations | MedDRA (13.1) |
|
| Catheter site infection | Infections and infestations | MedDRA (13.1) |
|
| Cellulitis | Infections and infestations | MedDRA (13.1) |
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| Clostridium difficile colitis | Infections and infestations | MedDRA (13.1) |
|
| Device related infection | Infections and infestations | MedDRA (13.1) |
|
| Device related sepsis | Infections and infestations | MedDRA (13.1) |
|
| Diabetic foot infection | Infections and infestations | MedDRA (13.1) |
|
| Gastroenteritis | Infections and infestations | MedDRA (13.1) |
|
| Necrotising fasciitis | Infections and infestations | MedDRA (13.1) |
|
| Pneumonia | Infections and infestations | MedDRA (13.1) |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA (13.1) |
|
| Septic shock | Infections and infestations | MedDRA (13.1) |
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA (13.1) |
|
| Tonsillitis | Infections and infestations | MedDRA (13.1) |
|
| Urinary tract infection | Infections and infestations | MedDRA (13.1) |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| Arteriovenous graft site haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA (13.1) |
|
| Liver function test abnormal | Investigations | MedDRA (13.1) |
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| Diabetic foot | Metabolism and nutrition disorders | MedDRA (13.1) |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (13.1) |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (13.1) |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (13.1) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.1) |
|
| Aortic dissection | Vascular disorders | MedDRA (13.1) |
|
| Hypotension | Vascular disorders | MedDRA (13.1) |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA (13.1) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.1) |
|
| Oedema peripheral | General disorders | MedDRA (13.1) |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) |
|
| Urinary tract infection | Infections and infestations | MedDRA (13.1) |
|
| Blood glucose decreased | Investigations | MedDRA (13.1) |
|
| Blood glucose increased | Investigations | MedDRA (13.1) |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.1) |
|
| Headache | Nervous system disorders | MedDRA (13.1) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) |
|
| Hypertension | Vascular disorders | MedDRA (13.1) |
|
| Hypotension | Vascular disorders | MedDRA (13.1) |
|
Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or colleagues may publish the results for their study site independently. 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.
| D004700 | Endocrine System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011719 |
| Pyrazines |
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| Change from Baseline to Week 54 |
|
| ANCOVA |
| <0.001 |
| Change from Baseline in LS Mean |
| -31.2 |
| 2-Sided |
| 95 |
| -42.6 |
| -19.9 |
| Superiority or Other |
| Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG. | Difference in LS Means | 4.6 | 2-Sided | 95 | -11.5 | 20.7 | Superiority or Other |