Trial Outcomes & Findings for Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes (NCT NCT00309608)
NCT ID: NCT00309608
Last Updated: 2014-07-08
Results Overview
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
333 participants
Primary outcome timeframe
Baseline and week 12
Results posted on
2014-07-08
Participant Flow
Participant milestones
| Measure |
Placebo
Patients randomized to receive treatment with matching placebo
|
Linagliptin 1 mg
Patients randomized to receive treatment with Linagliptin 1 mg
|
Linagliptin 5 mg
Patients randomized to receive treatment with Linagliptin 5 mg
|
Linagliptin 10 mg
Patients randomized to receive treatment with Linagliptin 10 mg
|
Glimepiride
Patients randomized to receive treatment with Glimepiride
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
65
|
66
|
66
|
65
|
|
Overall Study
COMPLETED
|
57
|
52
|
56
|
60
|
61
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
10
|
6
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Patients randomized to receive treatment with matching placebo
|
Linagliptin 1 mg
Patients randomized to receive treatment with Linagliptin 1 mg
|
Linagliptin 5 mg
Patients randomized to receive treatment with Linagliptin 5 mg
|
Linagliptin 10 mg
Patients randomized to receive treatment with Linagliptin 10 mg
|
Glimepiride
Patients randomized to receive treatment with Glimepiride
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
3
|
2
|
3
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
2
|
0
|
0
|
|
Overall Study
Other incl. Lack of efficacy
|
10
|
4
|
3
|
4
|
0
|
Baseline Characteristics
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=71 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin 1 mg
n=65 Participants
Patients randomized to receive treatment with Linagliptin 1 mg
|
Linagliptin 5 mg
n=66 Participants
Patients randomized to receive treatment with Linagliptin 5 mg
|
Linagliptin 10 mg
n=66 Participants
Patients randomized to receive treatment with Linagliptin 10 mg
|
Glimepiride
n=65 Participants
Patients randomized to receive treatment with Glimepiride
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
59.2 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
59.6 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
59.4 Years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
60.0 Years
STANDARD_DEVIATION 9.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
140 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
193 Participants
n=8 Participants
|
|
Body Mass Index (BMI) continuous
|
32.2 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 4.3 • n=7 Participants
|
31.7 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
31.7 kg/m^2
STANDARD_DEVIATION 4.5 • n=4 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 4.2 • n=21 Participants
|
31.9 kg/m^2
STANDARD_DEVIATION 4.3 • n=8 Participants
|
|
Glycosylated Hemoglobin A1 (HbA1C) continuous
|
8.37 Percent
STANDARD_DEVIATION 0.74 • n=5 Participants
|
8.24 Percent
STANDARD_DEVIATION 0.74 • n=7 Participants
|
8.46 Percent
STANDARD_DEVIATION 0.85 • n=5 Participants
|
8.35 Percent
STANDARD_DEVIATION 0.73 • n=4 Participants
|
8.22 Percent
STANDARD_DEVIATION 0.70 • n=21 Participants
|
8.33 Percent
STANDARD_DEVIATION 0.75 • n=8 Participants
|
|
Fasting plasma glucose (FPG) continuous
|
185.5 mg/dL
STANDARD_DEVIATION 38.8 • n=5 Participants
|
182.3 mg/dL
STANDARD_DEVIATION 42.0 • n=7 Participants
|
189.3 mg/dL
STANDARD_DEVIATION 42.4 • n=5 Participants
|
188.7 mg/dL
STANDARD_DEVIATION 42.4 • n=4 Participants
|
179.9 mg/dL
STANDARD_DEVIATION 40.4 • n=21 Participants
|
185.1 mg/dL
STANDARD_DEVIATION 41.0 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 12Population: The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.
Outcome measures
| Measure |
Placebo
n=70 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin 1 mg
n=64 Participants
Patients randomized to receive treatment with Linagliptin 1 mg
|
Linagliptin 5 mg
n=62 Participants
Patients randomized to receive treatment with Linagliptin 5 mg
|
Linagliptin 10 mg
n=66 Participants
Patients randomized to receive treatment with Linagliptin 10 mg
|
Glimepiride
n=64 Participants
Patients randomized to receive treatment with Glimepiride
|
|---|---|---|---|---|---|
|
HbA1c Change From Baseline at Week 12
|
0.25 Percent
Standard Error 0.10
|
-0.15 Percent
Standard Error 0.10
|
-0.48 Percent
Standard Error 0.11
|
-0.42 Percent
Standard Error 0.10
|
-0.59 Percent
Standard Error 0.10
|
SECONDARY outcome
Timeframe: week 12Population: This population includes the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used as the imputation rule.
Descriptive calculation of Patients with HbA1c \<= 7.0% at Week 12.
Outcome measures
| Measure |
Placebo
n=70 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin 1 mg
n=64 Participants
Patients randomized to receive treatment with Linagliptin 1 mg
|
Linagliptin 5 mg
n=62 Participants
Patients randomized to receive treatment with Linagliptin 5 mg
|
Linagliptin 10 mg
n=66 Participants
Patients randomized to receive treatment with Linagliptin 10 mg
|
Glimepiride
n=64 Participants
Patients randomized to receive treatment with Glimepiride
|
|---|---|---|---|---|---|
|
Percentage of Patients With HbA1c<=7.0% at Week 12
|
1.4 Percentage of Patients
|
15.6 Percentage of Patients
|
14.5 Percentage of Patients
|
21.2 Percentage of Patients
|
31.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Outcome measures
| Measure |
Placebo
n=68 Participants
Patients randomized to receive treatment with matching placebo
|
Linagliptin 1 mg
n=63 Participants
Patients randomized to receive treatment with Linagliptin 1 mg
|
Linagliptin 5 mg
n=62 Participants
Patients randomized to receive treatment with Linagliptin 5 mg
|
Linagliptin 10 mg
n=66 Participants
Patients randomized to receive treatment with Linagliptin 10 mg
|
Glimepiride
Patients randomized to receive treatment with Glimepiride
|
|---|---|---|---|---|---|
|
Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12
|
13.63 mg/dL
Standard Error 4.30
|
-5.32 mg/dL
Standard Error 4.51
|
-21.29 mg/dL
Standard Error 4.48
|
-15.87 mg/dL
Standard Error 4.33
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Linagliptin 1 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Linagliptin 5 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Linagliptin 10 mg
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Glimepiride
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=71 participants at risk
Patients randomized to receive treatment with matching placebo
|
Linagliptin 1 mg
n=65 participants at risk
Patients randomized to receive treatment with Linagliptin 1 mg
|
Linagliptin 5 mg
n=66 participants at risk
Patients randomized to receive treatment with Linagliptin 5 mg
|
Linagliptin 10 mg
n=66 participants at risk
Patients randomized to receive treatment with Linagliptin 10 mg
|
Glimepiride
n=65 participants at risk
Patients randomized to receive treatment with Glimepiride
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Endocrine disorders
Goitre
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
General disorders
Chest pain
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
1/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
1.5%
1/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
Other adverse events
| Measure |
Placebo
n=71 participants at risk
Patients randomized to receive treatment with matching placebo
|
Linagliptin 1 mg
n=65 participants at risk
Patients randomized to receive treatment with Linagliptin 1 mg
|
Linagliptin 5 mg
n=66 participants at risk
Patients randomized to receive treatment with Linagliptin 5 mg
|
Linagliptin 10 mg
n=66 participants at risk
Patients randomized to receive treatment with Linagliptin 10 mg
|
Glimepiride
n=65 participants at risk
Patients randomized to receive treatment with Glimepiride
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.2%
3/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
6.1%
4/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
4.5%
3/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
0.00%
0/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
|
Infections and infestations
Nasopharyngitis
|
9.9%
7/71 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
6.2%
4/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
7.6%
5/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
7.6%
5/66 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
6.2%
4/65 • 12 Weeks + 30 Days
MedDRA version 10.0 was used for reporting.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
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