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This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool for the evaluation of both new and existing pharmacological treatments for type 2 diabetes, using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin, twice daily will lead to a statistically significant decrease in 24 hour weighted-mean glucose (WMG) relative to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo → Vildagliptin | Experimental | Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks | The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG. | At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C (HbA1C) At 2 Weeks | Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%). | At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment |
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Inclusion Criteria:
Exclusion Criteria:
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After enrollment, participants previously treated with both metformin and sulfonylurea, discontinued sulfonylurea usage and underwent washout of sulfonylurea over a period of 8 weeks prior to treatment. Non-washout participants were enrolled on a clinical regimen of metformin alone.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo → Vildagliptin | Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled |
| |||||||||||||
| 8 Weeks Washout |
| |||||||||||||
| 3 Weeks Placebo |
| |||||||||||||
| 12 Weeks Vildagliptin |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo → Vildagliptin | Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice 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 | 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks | The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG. | Per-Protocol Population: all participants who complied with the assigned medication during each period of study. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/dL | At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin 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 | Vildagliptin 50 mg | Vildagliptin tablets 50 mg twice daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reaction CGM Site | General disorders | MedDRA 15.0 | Systematic Assessment |
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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 |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| HbA1C At 12 Weeks |
Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%). |
| At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Vildagliptin |
Vildagliptin tablets 50 mg twice daily for 12 weeks |
|
|
|
| Secondary | Hemoglobin A1C (HbA1C) At 2 Weeks | Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%). | Per-Protocol Population: all participants who complied with the assigned medication during each period of study. | Posted | Mean | Standard Deviation | HbA1c (%) | At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment |
|
|
|
|
| Secondary | HbA1C At 12 Weeks | Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%). | Per-Protocol Population: all participants who complied with the assigned medication during each period of study. | Posted | Mean | Standard Deviation | HbA1c (%) | At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment |
|
|
|
|
| 0 |
| 23 |
| 8 |
| 23 |
| EG001 | Placebo | Placebo tablets twice daily for 3 weeks | 0 | 24 | 6 | 24 |
| Reaction site cannula | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Tiredness | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
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 |
| D006571 |
| Heterocyclic Compounds |