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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_045 |
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The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 100 mg | Experimental | Sitagliptin 100 mg |
|
| Sitagliptin 200 mg | Experimental | Sitagliptin 200 mg |
|
| Placebo/Pioglitazone | Placebo Comparator | Placebo/Pioglitazone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: sitagliptin 100 mg | Drug | sitagliptin 100 mg oral tablet once daily for 54 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 18 | Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. | Weeks 0-18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FPG at Week 18 | The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. | Weeks 0-18 |
| Change From Baseline in A1C at Week 54 | A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent. |
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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 |
|---|---|---|---|
| 17001471 | Background | Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H; Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006 Nov;49(11):2564-71. doi: 10.1007/s00125-006-0416-z. Epub 2006 Sep 26. |
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Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (Hemoglobin A1C ≥7% and ≤10.0%) on diet and exercise alone were eligible to enter the study.
First Patient In: 15-Oct-2004. Last Patient Last Visit: 28-Apr-2006. 60 medical clinics in the United States (US), 37 in 4 countries in Europe, and 17 in 5 countries in the rest of the world.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54. |
| FG001 | Sitagliptin 200 mg | The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54. |
| FG002 | Placebo/Pioglitazone | The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54. |
| BG001 | Sitagliptin 200 mg |
| 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 A1C at Week 18 | Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. | All Patients Treated included those with ≥1 dose of study therapy, had a baseline and ≥1 post-baseline value. For those with no data at Week 18, last post-baseline observation was carried forward. Data after initiation of glycemic rescue were considered missing. Analysis adjusted for baseline values and prior antihyperglycemic therapy status. | Posted | Least Squares Mean | 95% Confidence Interval | percent | Weeks 0-18 |
|
Weeks 0 to 54
Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes 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 100 mg | The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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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 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Comparator: sitagliptin 200 mg | Drug | sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks |
|
| Comparator: placebo | Drug | placebo oral tablet once daily during Phase A (Weeks 0-18) |
|
| Comparator: pioglitazone | Drug | pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54) |
|
| Weeks 0-54 |
| Change From Baseline in FPG at Week 54 | The change from baseline reflects the Week 54 FPG minus the Week 0 FPG. | Weeks 0-54 |
| Lost to Follow-up |
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| Patient Moved |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| Protocol specified discontinuation |
|
The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
| BG002 | Placebo/Pioglitazone | The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Hemoglobin A1C (A1C) | Mean | Standard Deviation | Percent |
|
| OG001 |
| Sitagliptin 200 mg |
The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54. |
| OG002 | Placebo/Pioglitazone | The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54. |
|
|
|
| Secondary | Change From Baseline in FPG at Week 18 | The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. | All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 18 for patients with no data at Week 18. Data after initiation of glycemic rescue were considered missing. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 0-18 |
|
|
|
|
| Secondary | Change From Baseline in A1C at Week 54 | A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent. | All Patients Treated included patients who received at least 1 dose of study therapy post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing. | Posted | Least Squares Mean | 95% Confidence Interval | percent | Weeks 0-54 |
|
|
|
| Secondary | Change From Baseline in FPG at Week 54 | The change from baseline reflects the Week 54 FPG minus the Week 0 FPG. | All Patients Treated included patients who received at least 1 dose of study therapy 1 post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 0-54 |
|
|
|
| 15 |
| 205 |
| 70 |
| 205 |
| EG001 | Sitagliptin 200 mg | The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54. | 12 | 206 | 55 | 206 |
| EG002 | Placebo/Pioglitazone | The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54. | 10 | 110 | 37 | 110 |
| Angina Pectoris | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Atrioventricular Block Complete | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Ventricular Extrasystoles | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Cataract | Eye 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 |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Complication Of Device Insertion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| Polytraumatism | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| Blood Potassium Decreased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Blood Sodium Decreased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 Bone | 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 |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Thyroid Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Thyroid Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Uterine Cancer | 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 |
|
| Haemorrhagic Stroke | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Vertebrobasilar Insufficiency | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Bladder Perforation | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Leriche Syndrome | Vascular disorders | 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 Glucose Increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Glycosylated Haemoglobin Increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Headache | Nervous system 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.
| D004700 | Endocrine System Diseases |
Model terms: treatment, baseline, prior anti-hyperglycemic therapy status |
| <0.002 |
| Mean Difference (Net) |
| -16.9 |
| Standard Deviation |
| 45.9 |
| 2-Sided |
| 95 |
| -27.6 |
| -6.1 |
| Superiority or Other |