Type 2 diabetes mellitus in adult patients requiring basal insulin therapy. Nutritional, Metabolic, Endocrine Type 2 diabetes
Conditions
Interventions
All data were collected three times during this study: at baseline, approximately 6 and approximately 12 months after starting insulin glargine 300 U/mL therapy. Baseline documentation had to start im
i.e. actual dose and frequency of dose changes during the last four weeks. Data had to be generated during daily therapeutic routine of the physicians. Any change in the patient’s antidiabetic therapy
Sponsors
Sanofi-Aventis Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes (oral antidiabetic drugs). 2. Adults and Seniors: Age at least 18 years, no upper age limit. 3. HbA1c between 7.5% to 10.0%. 4. Ability and willingness to perform blood glucose self-monitoring.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes. 2. Contraindications for a therapy with insulin glargine 300 U/mL. 3. Any kind of existing insulin therapy. 4. Patients with known cancer disease. 5. Pregnancy. 6. Drug or alcohol abuse. 7. Dementia or general incapacity to understand the content of the observational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c response rate during month 1-6 and month 1-12 after start of insulin glargine 300 U/mL treatment, respectively; Response being defined as achieving at least one HbA1c value below the predefined individual target value within the respective observational period. Response rates were summarized with frequency distribution and, in addition, adjusted frequency distribution considering only patients with non-missing data. Exact 95% confidence intervals (CI) according to Clopper-Pearson were calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute change in HbA1c from baseline to 6 to 12 months 2. Absolute change in FBG from baseline to 6 to 12 months 3. Response rate 6 and 12 months after start of insulin glargine 300 U/mL treatment defined by 3.1 reaching two FBG values =110 mg/dL (=6.1 mmol/L) or at least once the predefined individual HbA1c target value 3.2 reaching two FBG values =110 mg/dL (=6.1 mmol/L) 3.3 reaching two FBG values =110 mg/dL (=6.1 mmol/L) and at least once the predefined individual HbA1c target value 4. Time from start of insulin glargine 300 U/mL treatment to response for each of the response endpoints (see definitions above, including primary efficacy parameter) was analyzed using Kaplan-Meier methods. Reaching a response criterion for the first time was considered as event in these analyses. Response in FBG required at least two values =110 mg/dL (=6.1 mmol/L) whereas start of response was defined at the first occurrence. Patients without response were censored at the date of last measurement of FBG or HbA1c, respectively. Median time to response and corresponding 95% CI were estimated using the Kaplan-Meier method. In addition, cumulative incidence curves were produced. 5. Duration (persistence) of response for each of the response endpoints (see definitions above, including primary efficacy parameter) was analyzed using Kaplan-Meier methods. Only patients with documented response and valid duration time (not missing, not negative) were included in these analyses. End of response was defined as one of the following (depending on endpoint definition): 5.1 the second FBG value >110 mg/dL (>6.1 mmol/L) after start of FBG response 5.2 the first HbA1c value above the predefined individual target 5.3 change to another form of insulin therapy or change of basal insulin Patients without documented end of response were censored at the date of last measurement of FBG or HbA1c, respectively. Median duration of response and corresponding 95% CI were estimated using the Kaplan-Meier | — |
Countries
Germany, Switzerland
Outcome results
None listed