| Primary | Weighted Mean Glucose (WMG) Change From Baseline at Day 28 | The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG. | The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for WMG. Sitagliptin results are from model containing all 3 groups | Posted | | Mean | Standard Error | mg/dL | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | BI1356 | Patients randomized to receive treatment with BI1356 5 mg | | OG002 | Sitagliptin | Patients randomized to receive treatment with Sitagliptin 100 mg |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.1± 3.0
- OG001-19.8± 2.9
- OG002-26.1± 2.8
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups | <0.0001 | There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) was to be considered descriptive. | Mean Difference (Final Values) | -19.9 | Standard Error of the Mean | 4.0 | | 95 | -28.0 | -11.9 | | | | No | Superiority or Other |
|
| Primary | GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28 | The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1. | The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. Analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one ontreatment value for GLP-1. Sitagliptin results are from model containing all 3 groups. | Posted | | Mean | Standard Error | pmol*h/L | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | BI1356 | Patients randomized to receive treatment with BI1356 5 mg | | OG002 | Sitagliptin | Patients randomized to receive treatment with Sitagliptin 100 mg |
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| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline at Day 28 | The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG. | The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for FPG. Sitagliptin results are from model containing all 3 groups | Posted | | Mean | Standard Error | mg/dL | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | BI1356 | Patients randomized to receive treatment with BI1356 5 mg | | OG002 | Sitagliptin | Patients randomized to receive treatment with Sitagliptin 100 mg |
| |
| Secondary | Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28 | The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h). | The pharmacodynamic set (PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo, further restricted to patients who had a baseline and at least one on-treatment value for Glucose AUEC(0-3h). Sitagliptin results from model with all 3 groups. | Posted | | Mean | Standard Error | mg*h/dL | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | BI1356 | Patients randomized to receive treatment with BI1356 5 mg | | OG002 | Sitagliptin | Patients randomized to receive treatment with Sitagliptin 100 mg |
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| Other Pre-specified | Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28 | The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG. | This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for WMG. | Posted | | Mean | Standard Error | mg/dL | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | BI1356 | Patients randomized to receive treatment with BI1356 5 mg | | OG002 | Sitagliptin | Patients randomized to receive treatment with Sitagliptin 100 mg |
| |
| Other Pre-specified | Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28 | The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1. | This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for GLP-1. | Posted | | Mean | Standard Error | pmol*h/L | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | BI1356 | Patients randomized to receive treatment with BI1356 5 mg | | OG002 | Sitagliptin | Patients randomized to receive treatment with Sitagliptin 100 mg |
| |
| Other Pre-specified | Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28 | The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG. | This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for FPG. | Posted | | Mean | Standard Error | mg/dL | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | BI1356 | Patients randomized to receive treatment with BI1356 5 mg | | OG002 | Sitagliptin | Patients randomized to receive treatment with Sitagliptin 100 mg |
| |
| Other Pre-specified | Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28 | The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG. | This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for Plasma Glucose AUEC (0-3h). | Posted | | Mean | Standard Error | mg*h/dL | | Baseline and day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Patients randomized to receive treatment with matching placebo | | OG001 | BI1356 | Patients randomized to receive treatment with BI1356 5 mg | | OG002 | Sitagliptin | Patients randomized to receive treatment with Sitagliptin 100 mg |
| |