Trial Outcomes & Findings for The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients (NCT NCT00716092)
NCT ID: NCT00716092
Last Updated: 2014-06-27
Results Overview
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.
COMPLETED
PHASE2
121 participants
Baseline and day 28
2014-06-27
Participant Flow
Participant milestones
| Measure |
Placebo
Patients randomized to receive treatment with matching placebo
|
BI1356
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
41
|
|
Overall Study
COMPLETED
|
38
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Patients randomized to receive treatment with matching placebo
|
BI1356
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Overall Study
Other incl. Lack of Efficacy
|
2
|
1
|
0
|
Baseline Characteristics
The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=40 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=41 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
60.7 Years
STANDARD_DEVIATION 10.11 • n=7 Participants
|
62.0 Years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
61.1 Years
STANDARD_DEVIATION 9.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Body Mass Index (BMI) continuous
|
30.3 kg/m^2
STANDARD_DEVIATION 3.83 • n=5 Participants
|
31.4 kg/m^2
STANDARD_DEVIATION 4.48 • n=7 Participants
|
30.7 kg/m^2
STANDARD_DEVIATION 4.56 • n=5 Participants
|
30.8 kg/m^2
STANDARD_DEVIATION 4.29 • n=4 Participants
|
|
Glycosylated Hemoglobin A1 (HbA1C) continuous
|
7.47 Percent
STANDARD_DEVIATION 0.53 • n=5 Participants
|
7.32 Percent
STANDARD_DEVIATION 0.59 • n=7 Participants
|
7.17 Percent
STANDARD_DEVIATION 0.44 • n=5 Participants
|
7.32 Percent
STANDARD_DEVIATION 0.53 • n=4 Participants
|
|
Fasting plasma glucose (FPG) continuous
|
172.8 mg/dL
STANDARD_DEVIATION 28.81 • n=5 Participants
|
166.9 mg/dL
STANDARD_DEVIATION 27.65 • n=7 Participants
|
160.3 mg/dL
STANDARD_DEVIATION 25.35 • n=5 Participants
|
166.6 mg/dL
STANDARD_DEVIATION 27.55 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 28Population: 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
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=39 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=40 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Weighted Mean Glucose (WMG) Change From Baseline at Day 28
|
0.1 mg/dL
Standard Error 3.0
|
-19.8 mg/dL
Standard Error 2.9
|
-26.1 mg/dL
Standard Error 2.8
|
PRIMARY outcome
Timeframe: Baseline and day 28Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=39 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=41 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28
|
0.4 pmol*h/L
Standard Error 2.1
|
18.5 pmol*h/L
Standard Error 2.1
|
15.3 pmol*h/L
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline and day 28Population: 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
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=39 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=41 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline at Day 28
|
-0.1 mg/dL
Standard Error 3.6
|
-10.9 mg/dL
Standard Error 3.5
|
-15.6 mg/dL
Standard Error 3.1
|
SECONDARY outcome
Timeframe: Baseline and day 28Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=38 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=39 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=41 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28
|
8.1 mg*h/dL
Standard Error 15.1
|
-98.4 mg*h/dL
Standard Error 14.7
|
-119.1 mg*h/dL
Standard Error 13.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and day 28Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=39 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=40 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28
|
-0.2 mg/dL
Standard Error 2.9
|
-20.1 mg/dL
Standard Error 2.8
|
-26.1 mg/dL
Standard Error 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and day 28Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=39 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=41 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28
|
-0.1 pmol*h/L
Standard Error 2.0
|
18.1 pmol*h/L
Standard Error 2.0
|
15.3 pmol*h/L
Standard Error 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and day 28Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=39 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=41 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28
|
0.4 mg/dL
Standard Error 3.2
|
-10.3 mg/dL
Standard Error 3.1
|
-15.6 mg/dL
Standard Error 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and day 28Population: 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).
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.
Outcome measures
| Measure |
Placebo
n=38 Participants
Patients randomized to receive treatment with matching placebo
|
BI1356
n=39 Participants
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=41 Participants
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28
|
9.8 mg*h/dL
Standard Error 14.0
|
-96.4 mg*h/dL
Standard Error 13.5
|
-119.1 mg*h/dL
Standard Error 13.3
|
Adverse Events
Placebo
BI1356
Sitagliptin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=40 participants at risk
Patients randomized to receive treatment with matching placebo
|
BI1356
n=40 participants at risk
Patients randomized to receive treatment with BI1356 5 mg
|
Sitagliptin
n=41 participants at risk
Patients randomized to receive treatment with Sitagliptin 100 mg
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • From day of first dose until 7 days after last dose, up to 35 days
|
7.5%
3/40 • From day of first dose until 7 days after last dose, up to 35 days
|
2.4%
1/41 • From day of first dose until 7 days after last dose, up to 35 days
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • From day of first dose until 7 days after last dose, up to 35 days
|
10.0%
4/40 • From day of first dose until 7 days after last dose, up to 35 days
|
12.2%
5/41 • From day of first dose until 7 days after last dose, up to 35 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER