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The purpose of this study is to collect information of the risk profile of patients with type 2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October 13, 2008
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Participants |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for Mean Hemoglobin A1c (HbA1C) | Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value. | Baseline and end of Observation (up to Month 6) |
| Change From Baseline for Mean Fasting Blood Glucose (FBG) | Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value. | Baseline and end of Observation (up to Month 6) |
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Inclusion Criteria:
- Newly diagnosed with Type 2 diabetes in whom treatment with metformin in
the individual maximal tolerated dose (at least four weeks on stable dose) resulted in
HbA1c >6.5%
- No contraindication or intolerability to metformin
Exclusion Criteria:
- Currently being administered a combination therapy for the treatment of their Type 2 diabetes
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Participants with type 2 diabetes mellitus being treated in an office setting with metformin at the individual maximal tolerated dose (at least four weeks on stable dose) and had a resultant HbA1c >6.5% were selected for this study. The first five eligible participants per site with type 2 diabetes mellitus and treatment with metformin were to be enrolled.
Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline. |
| 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 | Change From Baseline for Mean Hemoglobin A1c (HbA1C) | Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value. | Participants from the full analysis set with available data. | Posted | Mean | Standard Deviation | Percent of glycosylated hemoglobin | Baseline and end of Observation (up to Month 6) |
|
|
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Adverse events were not collected as part of this register. All adverse events occurring during the conduct of the register were to be reported to the pharmaceutical company responsible for the drug under which the participant experienced the adverse event.
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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 | All Enrolled Participants |
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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 |
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| 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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| years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c (HbA1c) | Population for this baseline characteristic consists of participants with available data, n=1519 | Mean | Standard Deviation | Percent of glycosylated hemoglobin |
|
| Fasting blood glucose (FBG) | Population for this baseline characteristic consists of participants with available data, n=1366 | Mean | Standard Deviation | mg/dL |
|
|
| Primary | Change From Baseline for Mean Fasting Blood Glucose (FBG) | Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value. | Participants from the full analysis set with available data. | Posted | Mean | Standard Deviation | mg/dL | Baseline and end of Observation (up to Month 6) |
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| 0 |
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| 0 |
| 0 |
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| D004700 | Endocrine System Diseases |