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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_513 | |||
| MK-0431-229 | Other Identifier | protocol number |
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This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo/pioglitazone | Active Comparator | Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg |
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| Sitagliptin | Experimental | Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin phosphate | Drug | Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (%) at Week 24 | Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin. | Baseline and Week 24 |
| Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54 | Week 0 to Week 54 | |
| Number of Participants Discontinuing Study Drug Due to An Adverse Event | Week 0 to Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 2-hour Post-Meal Glucose at Week 24 | Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal. | Baseline and Week 24 |
| Change From Baseline in Fasting Plasma Glucose at Week 24 |
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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 |
|---|---|---|---|
| 26625270 | Result | Moses RG, Round E, Shentu Y, Golm GT, O'neill EA, Gantz I, Engel SS, Kaufman KD, Goldstein BJ. A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. J Diabetes. 2016 Sep;8(5):701-11. doi: 10.1111/1753-0407.12351. Epub 2016 Feb 3. |
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762 participants were screened, 335 participants were excluded, and 427 participants were randomized. There was a single-blind run-in prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin | Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone |
| FG001 | Placebo/Pioglitazone | Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: placebo to pioglitazone | Drug | Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks |
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| Comparator: placebo to Sitagliptin | Drug | Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks |
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| Comparator: pioglitazone | Drug | Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks |
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| Glimepiride or gliclazide | Drug | Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide |
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| Metformin | Drug | Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of metformin; Phase B (Weeks 24- 54): stable dose, as prescribed by investigator, of metformin |
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| Pioglitazone rescue therapy | Drug | Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone. |
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Change from baseline reflects the Week 24 value minus the baseline value. |
| Baseline to Week 24 |
| Completed Phase A |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin | Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone |
| BG001 | Placebo/Pioglitazone | Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Number of Baseline Participants for Sitagliptin (210) and for Placebo/Pioglitazone (212). Five participants (Sitagliptin: 3, Placebo/Pioglitazone: 2) were excluded from analyses due to one site's non-compliance. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Number of Baseline Participants for Sitagliptin (210) and for Placebo/Pioglitazone (212). Five participants (Sitagliptin: 3, Placebo/Pioglitazone: 2) were excluded from analyses due to one site's non-compliance. | Count of Participants | Participants |
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| Hemoglobin A1C | Number of Baseline Participants for Sitagliptin (210) and for Placebo/Pioglitazone (212). Five participants (Sitagliptin: 3, Placebo/Pioglitazone: 2) were excluded from analyses due to one site's non-compliance. | Mean | Standard Deviation | Percentage of glycosylated hemoglobin |
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| 2-Hour Post-Meal Glucose | Number of Baseline Participants for Sitagliptin (202) and for Placebo/Pioglitazone (208). Five participants (Sitagliptin: 3, Placebo/Pioglitazone: 2) were excluded from analyses due to one site's non-compliance. | Mean | Standard Deviation | mg/dL |
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| Fasting Plasma Glucose | Number of Baseline Participants for Sitagliptin (210) and for Placebo/Pioglitazone (212). Five participants (Sitagliptin: 3, Placebo/Pioglitazone: 2) were excluded from analyses due to one site's non-compliance. | Mean | Standard Deviation | mg/dL |
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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 (%) at Week 24 | Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin. | The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of glycosylated hemoglobin | Baseline and Week 24 |
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| Secondary | Change From Baseline in 2-hour Post-Meal Glucose at Week 24 | Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal. | The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 24 | Change from baseline reflects the Week 24 value minus the baseline value. | The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline to Week 24 |
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| Primary | Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54 | The All Patients as Treated Population took at least one dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Adverse events include those that occurred prior to a receiving rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance. | Posted | Number | participants | Week 0 to Week 54 |
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| Primary | Number of Participants Discontinuing Study Drug Due to An Adverse Event | The All Patients as Treated Population took at least 1 dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Participants discontinued due to adverse events are reported regardless of rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance. | Posted | Number | participants | Week 0 to Week 54 |
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Week 0 to Week 54
All Patients as Treated Population took at least 1 dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Serious AEs (SAEs) are reported regardless of rescue medication. Other AEs are those that occurred prior to rescue medication. Five participants were excluded from analyses.
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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) |
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| EG000 | Sitagliptin | Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone | 6 | 210 | 49 | 210 | ||
| EG001 | Placebo/Pioglitazone | Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg | 9 | 212 | 44 | 212 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Skull fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Bladder neck obstruction | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Hypoglcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | 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. Sponsor review can be expedited to meet publication timelines.
| 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 |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000077205 | Pioglitazone |
| C057619 | glimepiride |
| D005907 | Gliclazide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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| Male |
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