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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_054 |
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The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B. |
|
| Placebo | Placebo Comparator | Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin | Drug | One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment | Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment. | Week 0 through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Sitagliptin Over 54 Weeks | Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment. | Week 0 through Week 54 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18518892 | Background | Chan JC, Scott R, Arjona Ferreira JC, Sheng D, Gonzalez E, Davies MJ, Stein PP, Kaufman KD, Amatruda JM, Williams-Herman D. Safety and efficacy of sitagliptin in patients with type 2 diabetes and chronic renal insufficiency. Diabetes Obes Metab. 2008 Jul;10(7):545-55. doi: 10.1111/j.1463-1326.2008.00914.x. Epub 2008 Jun 1. |
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Patients ≥18 years of age with chronic renal insufficiency and type 2 diabetes mellitus who had an A1C of 6.5-10% (not on baseline insulin therapy) or 7.5-10% (on baseline insulin therapy) after an antihyperglycemic agent (AHA) wash-off period of up to 12 weeks, were eligible to enter the 54-week
study.
First Patient In: 14-Dec-04
Last Patient Last Visit: 27-Jul-06
75 study centers worldwide
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase A (Weeks 0-12) |
|
Not provided
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|
| Placebo to Sitagliptin | Drug | One (participants with visit 1 estimated creatinine clearance <30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to <50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily. |
|
| glipizide | Drug | One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations. |
|
| Placebo to glipizide | Drug | One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations. |
|
| FG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase B (Weeks 12-54) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication. |
| BG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| HbA1c (Hemoglobin A1c) | Mean | Standard Deviation | Percent |
|
| 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 | Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment | Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment. | All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs. | Posted | Number | Participants | Week 0 through Week 12 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability of Sitagliptin Over 54 Weeks | Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment. | All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs. | Posted | Number | Participants | Week 0 through Week 54 |
|
Week 0 through Week 54
Patients received rescue medication if they met specific glycemic goals. This summary of SAEs includes events that occurred either before or after receiving rescue medication. This summary of Other AEs includes only those AEs that occurred prior to a patient receiving rescue medication.
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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 | The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication. | 20 | 65 | 29 | 65 | ||
| EG001 | Placebo | The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication. | 10 | 26 | 20 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Coronary Artery Stenosis | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Retinopathy | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Large Intestinal Haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arteriovenous Graft Site Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arteriovenous Fistula Thrombosis | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Polytraumatism | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diabetic Foot | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Metastases To Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Thalamic Infarction | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal Artery Stenosis | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Catheter Site Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| 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 |
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 |
| D011719 | Pyrazines |
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Withdrawal by Subject |
|
| Patient Moved |
|
| Death |
|
| Protocol specific criteria |
|
| Protocol Violation |
|
| Male |
|
| Black |
|
| Hispanic |
|
| Asian |
|
| Other |
|
| With serious CAEs |
|
| With LAEs |
|
| With drug-related LAEs |
|
| With serious LAEs |
|
| OG001 |
| Placebo |
The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication. |
|
|