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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_577 |
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This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 100 mg tablet orally once daily for 26 weeks. |
|
| Placebo | Placebo Comparator | Placebo to sitagliptin orally once daily for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 100 mg tablet orally once daily for 26 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) at Week 26 | Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin. | Baseline and Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26 | Change from baseline reflects the Week 26 value minus the baseline value. | Baseline and Week 26 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
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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 |
|---|---|---|---|
| 23116881 | Derived | Fonseca V, Staels B, Morgan JD 2nd, Shentu Y, Golm GT, Johnson-Levonas AO, Kaufman KD, Goldstein BJ, Steinberg H. Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes. J Diabetes Complications. 2013 Mar-Apr;27(2):177-83. doi: 10.1016/j.jdiacomp.2012.09.007. Epub 2012 Oct 30. |
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Lab abnormalities (the reason for discontinuation cited below) included creatinine, creatinine clearance, and estimated glomerular filtration rate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Sitagliptin 100 mg once daily |
| FG001 | Placebo | Placebo to sitagliptin once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Sitagliptin 100 mg once daily |
| BG001 | Placebo | Placebo to sitagliptin once daily |
| 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 (A1C) at Week 26 | Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin. | Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward. | Posted | Least Squares Mean | 95% Confidence Interval | Percent of glycosylated hemoglobin | Baseline and Week 26 |
|
Weeks 0 to 26
Participants received glycemic rescue medication if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue medication. Other adverse events only include those AEs that occurred prior to a participant 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 | Sitagliptin 100 mg once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 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 |
| 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 |
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| D005913 | Glipizide |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Comparator: Placebo | Drug | Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks. |
|
| Pioglitazone | Drug | Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable period followed by a 2-week single-blind run-in and a 26-week treatment period. Participants taking 4 mg or more rosiglitazone oral tablet(s) daily at screening in combination with metformin were to be switched to a corresponding dose of pioglitazone prior to starting a 4-week dose-stable period. Participants who are taking less than 30 mg/day or no pioglitazone at screening will be titrated to a stable dose of at least 30 mg pioglitazone once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with pioglitazone will be up to 42 weeks. |
|
|
| Metformin | Drug | Participants taking 1500 mg or more metformin oral tablet(s) and at least 30 mg pioglitazone or 4 mg rosiglitazone daily at screening will enter a 4-week dose-stable period followed by a 2-week single-blind placebo run-in, and a 26-week treatment period. Participants who are taking less than 1500 mg/day metformin at screening will be titrated to a stable dose of at least 1500 mg metformin once daily over a maximum of 4 weeks followed by a dose-stable period of 10 weeks, a 2-week single-blind placebo run-in, and a 26-week treatment period. Total treatment with metformin will be up to 42 weeks. |
|
|
| Glipizide | Drug | Participants not meeting specific glycemic controls during the 26-week treatment period will use glipizide oral tablets as rescue therapy. In countries where glipizide is not available, participants will receive a sulfonylurea marketed in that country. |
|
|
Change from baseline reflects the Week 26 value minus the baseline value.
| Baseline and Week 26 |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Contradiction to study medication |
|
| Excluded medication |
|
| Lab abnormalities |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Hemoglobin A1c (A1C) | Mean | Standard Deviation | Percent of gylcosylated hemoglobin |
|
| 2-hour post-meal glucose (PMG) | Participant population included 147 sitagliptin participants and 147 placebo participants. | Mean | Standard Deviation | mg/dL |
|
| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26 | Change from baseline reflects the Week 26 value minus the baseline value. | Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 26 |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | Change from baseline reflects the Week 26 value minus the baseline value. | Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 26 |
|
|
|
| 3 |
| 157 |
| 22 |
| 157 |
| EG001 | Placebo | Placebo to sitagliptin once daily | 6 | 156 | 20 | 156 |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 13.1 |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Chest discomfort | General disorders | MedDRA 13.1 |
|
| Appendicitis | Infections and infestations | MedDRA 13.1 |
|
| Dengue fever | Infections and infestations | MedDRA 13.1 |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Renal colic | Renal and urinary disorders | MedDRA 13.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 |
|
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 |
| D011719 |
| Pyrazines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D013453 | Sulfonylurea Compounds |
| D013450 | Sulfones |