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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_518 |
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This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850 | Experimental | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
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| 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC | Experimental | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
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| 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500 | Experimental | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co-administration of 50 mg sitagliptin and 500 mg metformin | Drug | Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0-t)) for Sitagliptin | AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg. | baseline through 72 hours postdose |
| Cmax for Sitagliptin and Metformin | Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg. | baseline through 72 hours postdose |
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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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28 participants were randomized in four treatment sequences. Participants had a 7 day minimum washout period between treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850 | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC | Experimental | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
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| sitagliptin/metformin 50 mg/500 mg tablet | Drug | Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours. |
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| Co-administration of 50 mg sitagliptin and 850 mg metformin | Drug | Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours. |
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| sitagliptin/metformin 50 mg/850 mg tablet | Drug | Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours. |
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| FG001 | 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
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| FG002 | 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500 | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
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| FG003 | 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:
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| NOT COMPLETED |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| Treatment Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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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 | Area Under the Curve (AUC(0-t)) for Sitagliptin | AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg. | Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis. | Posted | Mean | Standard Deviation | hr*ng/mL | baseline through 72 hours postdose |
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| Primary | Cmax for Sitagliptin and Metformin | Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg. | Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis. | Posted | Mean | Standard Deviation | ng/mL | baseline through 72 hours postdose |
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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 | Sit 50 mg + Met 500 mg | AEs reported in participants after co-administration of 50 mg sitagliptin and 500 mg metformin. | 0 | 28 | 4 | 28 | ||
| EG001 | Sit/Met 50 mg/500 mg FDC | AEs reported in participants after administration of the sitagliptin/metformin 50 mg/500 mg fixed dose combination (FDC) tablet. | 0 | 28 | 3 | 28 | ||
| EG002 | Sit 50 mg + Met 850 mg | AEs reported in participants after co-administration of 50 mg sitagliptin and 850 mg metformin. | 0 | 28 | 4 | 28 | ||
| EG003 | Sit/Met 50 mg/850 mg FDC | AEs reported in participants after administration of sitagliptin 50 mg/metformin 850 mg FDC tablet. | 0 | 28 | 2 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (14.0) |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) |
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| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) |
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| Fever | General disorders | MedDRA (14.0) |
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| Vertigo | Ear and labyrinth disorders | MedDRA (14.0) |
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| Nausea | Gastrointestinal disorders | MedDRA (14.0) |
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| Flatulence | Gastrointestinal disorders | MedDRA (14.0) |
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| Chest pain | General disorders | MedDRA (14.0) |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) |
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| Leucocytosis | Blood and lymphatic system disorders | MedDRA (14.0) | Laboratory finding |
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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. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 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 |
| D008687 | Metformin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| metformin 500 mg |
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| metformin 850 mg |
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Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences. |
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