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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_521 |
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This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin + placebo metformin | Experimental |
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| Metformin + placebo sitagliptin | Experimental |
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| Sitagliptin + metformin | Experimental | Co-administration of sitagliptin and metformin |
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| Placebo sitagliptin + placebo metformin | Placebo Comparator | Co-administration of placebo to sitagliptin and placebo to metformin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sitagliptin phosphate | Drug | Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations | Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period. | 6 hours postdose (4 hours postmeal) on Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| β-cell Sensitivity | β-cell sensitivity was defined as the incremental post-prandial 4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC. | 6 hour post-dose (4 hour postmeal) on Day 2 |
| Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Sitagliptin + Placebo Metformin |
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| metformin hydrochloride | Drug | Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods. |
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| Comparator: placebo sitagliptin | Drug | Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods. |
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| Comparator: placebo metformin | Drug | Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods. |
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Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period. |
| 6 hours postdose (4 hours postmeal) on Day 2 |
| COMPLETED |
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| NOT COMPLETED |
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| 7-day Washout |
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| Metformin + Placebo Sitagliptin |
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| 7-day Washout |
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| Sitagliptin + Metformin |
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| 7-day Washout |
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| Placebo Sitagliptin + Placebo Metformin |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations | Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period. | Posted | Least Squares Mean | 95% Confidence Interval | picomolar | 6 hours postdose (4 hours postmeal) on Day 2 |
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| Secondary | β-cell Sensitivity | β-cell sensitivity was defined as the incremental post-prandial 4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC. | Beta-cell sensitivity was not calculated for 1 participant following the administration of sitagliptin alone and metformin alone due to missing insulin data. | Posted | Least Squares Mean | 95% Confidence Interval | (ng/min)/(mg/dL)*10^ -3 | 6 hour post-dose (4 hour postmeal) on Day 2 |
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| Secondary | Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations | Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 6 hours postdose (4 hours postmeal) on Day 2 |
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43 days (four 2-day treatment periods, a 7-day washout interval between each treatment period, and approximately 14 days following the last dose of study treatment)
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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 + Placebo Metformin | Participants received sitagliptin + placebo metformin for 2 days. | 0 | 18 | 4 | 18 | ||
| EG001 | Metformin + Placebo Sitagliptin | Participants received metformin + placebo sitagliptin for 2 days. | 0 | 18 | 3 | 18 | ||
| EG002 | Sitagliptin + Metformin | Participants received co-administration of sitagliptin + metformin for 2 days. | 0 | 18 | 3 | 18 | ||
| EG003 | Placebo Sitagliptin + Placebo Metformin | Participants received placebo sitagliptin + placebo metformin for 2 days. | 0 | 18 | 4 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency anaemia | Blood and lymphatic system disorders | MedDRA (12.1) |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (12.1) |
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| Vision blurred | Eye disorders | MedDRA (12.1) |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) |
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| Nausea | Gastrointestinal disorders | MedDRA (12.1) |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.1) |
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| Fatigue | General disorders | MedDRA (12.1) |
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| Vessel puncture site pain | General disorders | MedDRA (12.1) |
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| Subcutaneous abscess | Infections and infestations | MedDRA (12.1) |
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| Hepatic enzyme increased | Investigations | MedDRA (12.1) |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) |
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| Headache | Nervous system disorders | MedDRA (12.1) |
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| Anxiety | Psychiatric disorders | MedDRA (12.1) |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) |
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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.
| 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 |
| D008687 | Metformin |
| 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 |
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| Placebo sitagliptin + placebo metformin |
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