Type 2 Diabetes Mellitus
Conditions
Brief summary
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
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Mean Hemoglobin A1c (HbA1C) | Baseline and end of Observation (up to Month 6) | Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value. |
| Change From Baseline for Mean Fasting Blood Glucose (FBG) | Baseline and end of Observation (up to Month 6) | Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value. |
Participant flow
Pre-assignment details
Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline. | 1,522 |
| Total | 1,522 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 10.8 |
| Fasting blood glucose (FBG) | 146.9 mg/dL STANDARD_DEVIATION 42 |
| Hemoglobin A1c (HbA1c) | 7.4 Percent of glycosylated hemoglobin STANDARD_DEVIATION 1.1 |
| Region of Enrollment Germany | 1522 participants |
| Sex/Gender, Customized Female | 841 Participants |
| Sex/Gender, Customized Male | 680 Participants |
| Sex/Gender, Customized Missing | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Baseline and end of Observation (up to Month 6)
Population: Participants from the full analysis set with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Participants | Change From Baseline for Mean Fasting Blood Glucose (FBG) | Change from baseline, n=1244 | -18.6 mg/dL | Standard Deviation 41.2 |
| All Enrolled Participants | Change From Baseline for Mean Fasting Blood Glucose (FBG) | End of observation; n=1346 | 127.8 mg/dL | Standard Deviation 34.7 |
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.
Time frame: Baseline and end of Observation (up to Month 6)
Population: Participants from the full analysis set with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Participants | Change From Baseline for Mean Hemoglobin A1c (HbA1C) | End of observation, n=1483 | 6.9 Percent of glycosylated hemoglobin | Standard Deviation 0.9 |
| All Enrolled Participants | Change From Baseline for Mean Hemoglobin A1c (HbA1C) | Change from baseline, n=1480 | -0.5 Percent of glycosylated hemoglobin | Standard Deviation 1 |