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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_535 |
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The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin/Sitagliptin | Experimental |
| |
| Placebo/Sitagliptin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Placebo | Drug | Placebo to sitagliptin once daily for 12 weeks (double-blind period) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 2-hour Postprandial Glucose at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. | Baseline and Week 12 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 |
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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 |
|---|---|---|---|
| 24843714 | Result | Tajima N, Kadowaki T, Okamoto T, Sato A, Okuyama K, Minamide T, Arjona Ferreira JC. Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes. J Diabetes Investig. 2013 Nov 27;4(6):595-604. doi: 10.1111/jdi.12116. Epub 2013 Jul 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin/Sitagliptin | Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period). |
| FG001 | Placebo/Sitagliptin | Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Period |
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| Open-label Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin/Sitagliptin | Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period). |
| BG001 | Placebo/Sitagliptin | Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period). |
| 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 |
| 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 (HbA1c) at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%). | Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of glycosylated hemoglobin | Baseline and Week 12 |
|
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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/Sitagliptin (Data Through Week 12) | Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 11.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 |
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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 |
| C102817 | voglibose |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sitagliptin | Drug | Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period). Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20. |
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| Voglibose | Drug | All participants received a stable dose of voglibose, in accordance with the package insert, throughout the study. |
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Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. |
| Baseline and Week 12 |
| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percent |
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| 2-hour Postprandial Glucose | Mean | Standard Deviation | mg/dL |
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| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
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| OG001 | Placebo/Sitagliptin | Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period). |
|
|
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| Secondary | Change From Baseline in 2-hour Postprandial Glucose at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. | Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. | Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 12 |
|
|
|
|
| 0 |
| 70 |
| 7 |
| 70 |
| EG001 | Placebo/Sitagliptin (Data Through Week 12) | Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period). | 1 | 63 | 5 | 63 |
| EG002 | Pooled Sitagliptin (Data Through Week 52) | The Pooled Sitagliptin group includes data from all participants who took sitagliptin in either treatment group: data from Week 0 to Week 52 for participants in the Sitagliptin/Sitagliptin group; data from Weeks 12 through Week 52 for participants in the Placebo/Sitagliptin group; and data from participants in either group who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. | 8 | 133 | 51 | 133 |
| Glaucoma | Eye disorders | MedDRA 11.1 |
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| Anal Stenosis | Gastrointestinal disorders | MedDRA 11.1 |
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| Gastric Ulcer | Gastrointestinal disorders | MedDRA 11.1 |
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| Inguinal Hernia | Gastrointestinal disorders | MedDRA 11.1 |
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| Pneumonia | Infections and infestations | MedDRA 11.1 |
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| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
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| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.1 |
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| Blood Triglycerides Increased | Investigations | MedDRA 11.1 |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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The only disclosure restriction on the PI is that the sponsor must have the opportunity to review all communications regarding trial results for 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 |