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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_549 | Other Identifier | Merck Registration Number |
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The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin + Placebo for Glipizide |
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| Glipizide | Active Comparator | Glipizide + Placebo for Sitagliptin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 | A1C represents percentage of glycosylated hemoglobin. | Baseline to Week 54 |
| Percentage of Participants With Hypoglycemic Events | Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy. | Baseline up to 28 days following the last dose of study therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 | Baseline to Week 54 | |
| Change From Baseline in Body Weight at Week 54 | Baseline to Week 54 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23248197 | Result | Arjona Ferreira JC, Marre M, Barzilai N, Guo H, Golm GT, Sisk CM, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care. 2013 May;36(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17. |
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One site was identified as non-compliant with some of the requirements of Good Clinical Practice. For this reason, data from the 3 participants randomized at this site were deemed unreliable and were removed from all analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide |
| FG001 | Glipizide | Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Glipizide | Drug | Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily) |
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| Placebo for Sitagliptin | Drug | Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily |
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| Placebo for Glipizide | Drug | Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide |
| BG001 | Glipizide | Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 | A1C represents percentage of glycosylated hemoglobin. | The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed. | Posted | Mean | Standard Deviation | Percent of glycosylated hemoglobin | Baseline to Week 54 |
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| Primary | Percentage of Participants With Hypoglycemic Events | Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy. | All participants as treated (APaT) population included all randomized participants who took at least one dose of study therapy. | Posted | Number | percentage of participants | Baseline up to 28 days following the last dose of study therapy |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 | The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed. | Posted | Mean | Standard Deviation | mg/dL | Baseline to Week 54 |
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| Secondary | Change From Baseline in Body Weight at Week 54 | All participants as treated (APaT) population included participants who had both baseline and Week 54 data (excluding data after initiation of glycemic rescue therapy). | Posted | Least Squares Mean | Standard Error | kg | Baseline to Week 54 |
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One participant from the sitagliptin group did not receive any study medication and, therefore, was excluded from all analyses. Analyses of safety used the APaT population (participants who had both baseline and Week 54 data, and for serious adverse events only, included data after the initiation of glycemic rescue therapy).
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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 | Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide | 36 | 210 | 69 | 210 | ||
| EG001 | Glipizide | Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin | 38 | 212 | 89 | 212 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Nodal arrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Uraemic gastropathy | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Lung abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
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| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
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| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Guillain-Barre syndrome | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Acute psychosis | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Nephropathy | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Renal failure chronic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.1 | 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 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| 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 |
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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 |
| D011719 | Pyrazines |
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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