Diabetes Mellitus, Type 2
Conditions
Brief summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo
Interventions
DRUGBI 1356
BI 1356 dosed once daily
DRUGplacebo
placebo matching BI 1356 taken once daily
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) \<30 ml/min, who are not on chronic dialysis. * Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%) * Age 18 or over and not older than 80 years
Exclusion criteria
* Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent * Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent * Unstable or acute congestive heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Change From Baseline at Week 12 | Baseline and Week 12 | HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Change From Baseline at Week 18 | Baseline and Week 18 | HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication. |
| HbA1c Change From Baseline at Week 24 | Baseline and Week 24 | HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication. |
| HbA1c Change From Baseline at Week 30 | Baseline and Week 30 | HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication. |
| HbA1c Change From Baseline at Week 36 | Baseline and Week 36 | HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication. |
| HbA1c Change From Baseline at Week 42 | Baseline and Week 42 | HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication. |
| HbA1c Change From Baseline at Week 48 | Baseline and Week 48 | HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication. |
| The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment | Baseline and Week 52 | The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=6.5% |
| The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment | Baseline and Week 52 | The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=7%. |
| Percentage of Patients With HbA1c Lowering by 0.5% at Week 52 | Baseline and Week 52 | The percentage of patients with an HbA1c reduction from baseline \>=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). |
| HbA1c Change From Baseline at Week 52 | Baseline and Week 52 | HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication. |
| FPG Change From Baseline at Week 18 | Baseline and Week 18 | Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs |
| FPG Change From Baseline at Week 24 | Baseline and Week 24 | This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs |
| FPG Change From Baseline at Week 30 | Baseline and Week 30 | This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs |
| FPG Change From Baseline at Week 36 | Baseline and Week 36 | This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs |
| FPG Change From Baseline at Week 42 | Baseline and Week 42 | This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs |
| FPG Change From Baseline at Week 48 | Baseline and Week 48 | This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs |
| FPG Change From Baseline at week52 | Baseline and Week 52 | This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs |
| Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Baseline and Week 52 | Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin. |
| Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | first administration of randomised treatment to .... | Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events. |
| FPG Change From Baseline at Week 12 | Baseline and Week 12 | This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs |
Countries
Australia, Hong Kong, Israel, New Zealand, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients randomized to receive treatment with matching placebo | 65 |
| Linagliptin (BI 1356) Patients randomized to receive treatment with Linagliptin 5mg | 68 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 8 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 7 |
Baseline characteristics
| Characteristic | Placebo | Linagliptin (BI 1356) | Total |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 9.6 | 64.0 years STANDARD_DEVIATION 10.9 | 64.4 years STANDARD_DEVIATION 10.3 |
| Body Mass Index (BMI) Continuous | 31.7 kg/m² STANDARD_DEVIATION 5.9 | 32.3 kg/m² STANDARD_DEVIATION 5.9 | 32.0 kg/m² STANDARD_DEVIATION 5.8 |
| Fasting plasma glucose (FPG) at baseline | 160.1 mg/dL STANDARD_DEVIATION 65.4 | 149.5 mg/dL STANDARD_DEVIATION 79.5 | 154.6 mg/dL STANDARD_DEVIATION 72.9 |
| Glycosylated haemoglobin (HbA1c) at baseline | 8.2 percentage STANDARD_DEVIATION 0.9 | 8.2 percentage STANDARD_DEVIATION 1.1 | 8.2 percentage STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 30 Participants | 23 Participants | 53 Participants |
| Sex: Female, Male Male | 35 Participants | 45 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 50 / 65 | 61 / 68 |
| serious Total, serious adverse events | 27 / 65 | 25 / 68 |
Outcome results
Primary
HbA1c Change From Baseline at Week 12
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time frame: Baseline and Week 12
Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline at Week 12 | -0.15 Percent | Standard Error 0.15 |
| Linagliptin (BI 1356) | HbA1c Change From Baseline at Week 12 | -0.76 Percent | Standard Error 0.14 |
Comparison: For patients who received rescue medication during the course of the trial, the Oracle Clinical (OC) technique was utilised for all efficacy endpoints and the values were set to missing after the rescue medication was administered.p-value: <0.000195% CI: [-0.89, -0.31]ANCOVA
Secondary
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Time frame: Baseline and Week 52
Population: Treated Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Week 1- Week12 | 11 Participants |
| Placebo | Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Week 12 - Week 52 | 29 Participants |
| Placebo | Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Overall (Baseline -Week 52) | 33 Participants |
| Linagliptin (BI 1356) | Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Week 1- Week12 | 17 Participants |
| Linagliptin (BI 1356) | Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Week 12 - Week 52 | 24 Participants |
| Linagliptin (BI 1356) | Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time | Overall (Baseline -Week 52) | 32 Participants |
Secondary
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Time frame: first administration of randomised treatment to ....
Population: Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Blood amylase increased | 1 participants |
| Placebo | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Blood creatine phosphokinase increased | 1 participants |
| Placebo | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Blood creatine phosphokinase MB increased | 1 participants |
| Placebo | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Glycosylated haemoglobin increased | 0 participants |
| Placebo | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Cardiac disorders - Tachycardia | 1 participants |
| Linagliptin (BI 1356) | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Glycosylated haemoglobin increased | 1 participants |
| Linagliptin (BI 1356) | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Cardiac disorders - Tachycardia | 0 participants |
| Linagliptin (BI 1356) | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Blood amylase increased | 0 participants |
| Linagliptin (BI 1356) | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Blood creatine phosphokinase MB increased | 1 participants |
| Linagliptin (BI 1356) | Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | Blood creatine phosphokinase increased | 2 participants |
Secondary
FPG Change From Baseline at Week 12
This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Time frame: Baseline and Week 12
Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FPG Change From Baseline at Week 12 | -7.08 mg/dL | Standard Error 11.08 |
| Linagliptin (BI 1356) | FPG Change From Baseline at Week 12 | -8.81 mg/dL | Standard Error 10.66 |
p-value: 0.880295% CI: [-24.36, 20.91]ANCOVA
Secondary
FPG Change From Baseline at Week 18
Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Time frame: Baseline and Week 18
Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FPG Change From Baseline at Week 18 | -12.72 mg/dL | Standard Error 7.94 |
| Linagliptin (BI 1356) | FPG Change From Baseline at Week 18 | -14.97 mg/dL | Standard Error 7.64 |
p-value: 0.784895% CI: [-18.47, 13.98]ANCOVA
Secondary
FPG Change From Baseline at Week 24
This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time frame: Baseline and Week 24
Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FPG Change From Baseline at Week 24 | -6.22 mg/dL | Standard Error 7.84 |
| Linagliptin (BI 1356) | FPG Change From Baseline at Week 24 | -16.93 mg/dL | Standard Error 7.54 |
p-value: 0.187895% CI: [-26.74, 5.31]ANCOVA
Secondary
FPG Change From Baseline at Week 30
This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time frame: Baseline and Week 30
Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FPG Change From Baseline at Week 30 | -14.54 mg/dL | Standard Error 7.68 |
| Linagliptin (BI 1356) | FPG Change From Baseline at Week 30 | -10.12 mg/dL | Standard Error 7.39 |
p-value: 0.578195% CI: [-11.28, 20.12]ANCOVA
Secondary
FPG Change From Baseline at Week 36
This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time frame: Baseline and Week 36
Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FPG Change From Baseline at Week 36 | -11.29 mg/dL | Standard Error 8.53 |
| Linagliptin (BI 1356) | FPG Change From Baseline at Week 36 | -20.53 mg/dL | Standard Error 8.2 |
p-value: 0.295495% CI: [-26.67, 8.18]ANCOVA
Secondary
FPG Change From Baseline at Week 42
This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time frame: Baseline and Week 42
Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FPG Change From Baseline at Week 42 | -13.25 mg/dL | Standard Error 8.02 |
| Linagliptin (BI 1356) | FPG Change From Baseline at Week 42 | -8.88 mg/dL | Standard Error 7.71 |
p-value: 0.598495% CI: [-12.02, 20.75]ANCOVA
Secondary
FPG Change From Baseline at Week 48
This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time frame: Baseline and Week 48
Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FPG Change From Baseline at Week 48 | -10.52 mg/dL | Standard Error 8.26 |
| Linagliptin (BI 1356) | FPG Change From Baseline at Week 48 | -3.45 mg/dL | Standard Error 7.95 |
p-value: 0.408595% CI: [-9.82, 23.96]ANCOVA
Secondary
FPG Change From Baseline at week52
This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Time frame: Baseline and Week 52
Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FPG Change From Baseline at week52 | -6.81 mg/dL | Standard Error 7.92 |
| Linagliptin (BI 1356) | FPG Change From Baseline at week52 | -5.47 mg/dL | Standard Error 7.62 |
p-value: 0.869895% CI: [-14.84, 17.52]ANCOVA
Secondary
HbA1c Change From Baseline at Week 18
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time frame: Baseline and Week 18
Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline at Week 18 | 0.04 Percent | Standard Error 0.14 |
| Linagliptin (BI 1356) | HbA1c Change From Baseline at Week 18 | -0.57 Percent | Standard Error 0.14 |
p-value: <0.000195% CI: [-0.9, -0.33]ANCOVA
Secondary
HbA1c Change From Baseline at Week 24
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time frame: Baseline and Week 24
Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline at Week 24 | 0.04 Percent | Standard Error 0.14 |
| Linagliptin (BI 1356) | HbA1c Change From Baseline at Week 24 | -0.64 Percent | Standard Error 0.13 |
p-value: <0.000195% CI: [-0.96, -0.41]ANCOVA
Secondary
HbA1c Change From Baseline at Week 30
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time frame: Baseline and Week 30
Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline at Week 30 | 0.04 Percent | Standard Error 0.16 |
| Linagliptin (BI 1356) | HbA1c Change From Baseline at Week 30 | -0.67 Percent | Standard Error 0.16 |
p-value: <0.000195% CI: [-1.05, -0.39]ANCOVA
Secondary
HbA1c Change From Baseline at Week 36
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time frame: Baseline and Week 36
Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline at Week 36 | 0.03 Percent | Standard Error 0.16 |
| Linagliptin (BI 1356) | HbA1c Change From Baseline at Week 36 | -0.72 Percent | Standard Error 0.15 |
p-value: <0.000195% CI: [-1.06, -0.44]ANCOVA
Secondary
HbA1c Change From Baseline at Week 42
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time frame: Baseline and Week 42
Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline at Week 42 | -0.08 Percent | Standard Error 0.16 |
| Linagliptin (BI 1356) | HbA1c Change From Baseline at Week 42 | -0.73 Percent | Standard Error 0.15 |
p-value: <0.000195% CI: [-0.96, -0.33]ANCOVA
Secondary
HbA1c Change From Baseline at Week 48
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time frame: Baseline and Week 48
Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline at Week 48 | -0.04 Percent | Standard Error 0.15 |
| Linagliptin (BI 1356) | HbA1c Change From Baseline at Week 48 | -0.77 Percent | Standard Error 0.14 |
p-value: <0.000195% CI: [-1.02, -0.44]ANCOVA
Secondary
HbA1c Change From Baseline at Week 52
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Time frame: Baseline and Week 52
Population: The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline at Week 52 | 0.01 Percent | Standard Error 0.16 |
| Linagliptin (BI 1356) | HbA1c Change From Baseline at Week 52 | -0.71 Percent | Standard Error 0.15 |
p-value: <0.000195% CI: [-1.03, -0.41]ANCOVA
Secondary
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
The percentage of patients with an HbA1c reduction from baseline \>=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
Time frame: Baseline and Week 52
Population: The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Patients With HbA1c Lowering by 0.5% at Week 52 | 11.3 Percentage of patients |
| Linagliptin (BI 1356) | Percentage of Patients With HbA1c Lowering by 0.5% at Week 52 | 27.3 Percentage of patients |
Comparison: Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearancep-value: 0.892795% CI: [0.042, 15.756]Regression, Logistic
Secondary
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=7%.
Time frame: Baseline and Week 52
Population: This population includes the FAS with baseline HbA1c\>=7.0%. Non-completers were considered as failure imputation (NCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment | 9.8 Percentage of patients |
| Linagliptin (BI 1356) | The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment | 18.0 Percentage of patients |
Comparison: Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearancep-value: 0.222595% CI: [0.003, 3.978]Regression, Logistic
Secondary
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c\>=6.5%
Time frame: Baseline and Week 52
Population: This population includes the FAS with baseline HbA1c\>=6.5%. Non-completers were considered as failure imputation (NCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment | 0 Percentage of patients |
| Linagliptin (BI 1356) | The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment | 6.1 Percentage of patients |
p-value: 0.1199Fisher Exact