Trial Outcomes & Findings for Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study (NCT NCT01194830)
NCT ID: NCT01194830
Last Updated: 2014-01-29
Results Overview
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
234 participants
Primary outcome timeframe
baseline, 24 weeks
Results posted on
2014-01-29
Participant Flow
Participant milestones
| Measure |
Placebo Tablet
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
110
|
|
Overall Study
COMPLETED
|
88
|
83
|
|
Overall Study
NOT COMPLETED
|
36
|
27
|
Reasons for withdrawal
| Measure |
Placebo Tablet
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Protocol Violation
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Non-compliance issues
|
4
|
4
|
|
Overall Study
Other Reason
|
12
|
8
|
Baseline Characteristics
Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study
Baseline characteristics by cohort
| Measure |
Placebo Tablet
n=120 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=106 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Age, Customized
< 65 years
|
104 Number of participants
n=5 Participants
|
89 Number of participants
n=7 Participants
|
193 Number of participants
n=5 Participants
|
|
Age, Customized
65 to 74 years
|
12 Number of participants
n=5 Participants
|
14 Number of participants
n=7 Participants
|
26 Number of participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
4 Number of participants
n=5 Participants
|
3 Number of participants
n=7 Participants
|
7 Number of participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Weight
|
99.02 kilograms
STANDARD_DEVIATION 20.16 • n=5 Participants
|
95.83 kilograms
STANDARD_DEVIATION 20.96 • n=7 Participants
|
97.52 kilograms
STANDARD_DEVIATION 20.55 • n=5 Participants
|
|
Weight categories
<= 70 kilograms
|
2 Number of participants
n=5 Participants
|
8 Number of participants
n=7 Participants
|
10 Number of participants
n=5 Participants
|
|
Weight categories
> 70 to 80 kilograms
|
21 Number of participants
n=5 Participants
|
18 Number of participants
n=7 Participants
|
39 Number of participants
n=5 Participants
|
|
Weight categories
> 80 to 90 kilograms
|
25 Number of participants
n=5 Participants
|
26 Number of participants
n=7 Participants
|
51 Number of participants
n=5 Participants
|
|
Weight categories
> 90 kilograms
|
72 Number of participants
n=5 Participants
|
54 Number of participants
n=7 Participants
|
126 Number of participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
33.35 kilograms per square meter
STANDARD_DEVIATION 5.36 • n=5 Participants
|
32.04 kilograms per square meter
STANDARD_DEVIATION 6.10 • n=7 Participants
|
32.74 kilograms per square meter
STANDARD_DEVIATION 5.74 • n=5 Participants
|
|
Body Mass Index (BMI) categories
< 30 kilograms/square meter
|
33 Number of participants
n=5 Participants
|
45 Number of participants
n=7 Participants
|
78 Number of participants
n=5 Participants
|
|
Body Mass Index (BMI) categories
>= 30 kilograms/square meter
|
87 Number of participants
n=5 Participants
|
61 Number of participants
n=7 Participants
|
148 Number of participants
n=5 Participants
|
|
Height
|
172.1 centimeters
STANDARD_DEVIATION 10.9 • n=5 Participants
|
172.8 centimeters
STANDARD_DEVIATION 10.3 • n=7 Participants
|
172.4 centimeters
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Waist circumference
|
111.5 centimeters
STANDARD_DEVIATION 16.7 • n=5 Participants
|
103.5 centimeters
STANDARD_DEVIATION 20.2 • n=7 Participants
|
107.7 centimeters
STANDARD_DEVIATION 18.8 • n=5 Participants
|
|
Smoking status
Never smoked
|
82 Number of participants
n=5 Participants
|
56 Number of participants
n=7 Participants
|
138 Number of participants
n=5 Participants
|
|
Smoking status
Ex-smoker
|
22 Number of participants
n=5 Participants
|
21 Number of participants
n=7 Participants
|
43 Number of participants
n=5 Participants
|
|
Smoking status
Currently smokes
|
16 Number of participants
n=5 Participants
|
29 Number of participants
n=7 Participants
|
45 Number of participants
n=5 Participants
|
|
Alcohol status
Non drinker
|
70 Number of participants
n=5 Participants
|
61 Number of participants
n=7 Participants
|
131 Number of participants
n=5 Participants
|
|
Alcohol status
Drinks - no interference with study
|
50 Number of participants
n=5 Participants
|
45 Number of participants
n=7 Participants
|
95 Number of participants
n=5 Participants
|
|
Alcohol status
Drinks - possible interference with study
|
0 Number of participants
n=5 Participants
|
0 Number of participants
n=7 Participants
|
0 Number of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 24 weeksPopulation: Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Outcome measures
| Measure |
Placebo Tablet
n=105 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=93 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
|
-0.25 Percentage
Standard Error 0.16
|
-0.84 Percentage
Standard Error 0.15
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Outcome measures
| Measure |
Placebo Tablet
n=105 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=93 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks
|
-0.22 Percentage
Standard Error 0.10
|
-0.64 Percentage
Standard Error 0.09
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Outcome measures
| Measure |
Placebo Tablet
n=105 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=93 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks
|
-0.17 Percentage
Standard Error 0.14
|
-0.72 Percentage
Standard Error 0.13
|
SECONDARY outcome
Timeframe: baseline, 18 weeksPopulation: Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Outcome measures
| Measure |
Placebo Tablet
n=105 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=93 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks
|
-0.26 Percentage
Standard Error 0.14
|
-0.81 Percentage
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set (FAS) includes all randomized patients who received study medication.
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Outcome measures
| Measure |
Placebo Tablet
n=110 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=98 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
Responder (HbA1c < 7.0%)
|
10 Participants
|
26 Participants
|
|
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
Non-responder (HbA1c >= 7.0%)
|
100 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set (FAS) includes all randomized patients who received study medication.
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Outcome measures
| Measure |
Placebo Tablet
n=110 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=98 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
Responder (HbA1c < 6.5%)
|
2 Participants
|
9 Participants
|
|
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
Non-responder (HbA1c >= 6.5%)
|
108 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Full Analysis Set (FAS) includes all randomized patients who received study medication.
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Outcome measures
| Measure |
Placebo Tablet
n=110 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=98 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
Responder (reduction in HbA1c >= 0.5%)
|
33 Participants
|
53 Participants
|
|
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
Non-responder (reduction in HbA1c < 0.5%)
|
77 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value.
Outcome measures
| Measure |
Placebo Tablet
n=106 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=95 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks
|
-11.0 mg/dL (milligrams per deciliter)
Standard Error 6.6
|
-22.9 mg/dL (milligrams per deciliter)
Standard Error 6.4
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Meal Tolerance Test, observed cases data set (MTT-OC) includes all randomized patients who participated in the MTT sub-study. Patients required to have both baseline and on-treatment results.
Outcome measures
| Measure |
Placebo Tablet
n=11 Participants
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=10 Participants
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks
|
-36.77 mg/dL (milligrams per deciliter)
Standard Error 23.76
|
-38.74 mg/dL (milligrams per deciliter)
Standard Error 22.77
|
Adverse Events
Placebo Tablet
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Linagliptin 5 mg Tablet
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Tablet
n=120 participants at risk
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=106 participants at risk
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/120 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
0.94%
1/106 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
|
Immune system disorders
Food allergy
|
0.83%
1/120 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
0.00%
0/106 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/120 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
0.94%
1/106 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
0.00%
0/106 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.83%
1/120 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
0.00%
0/106 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.83%
1/120 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
0.00%
0/106 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
Other adverse events
| Measure |
Placebo Tablet
n=120 participants at risk
Placebo matching linagliptin 5 mg tablet
|
Linagliptin 5 mg Tablet
n=106 participants at risk
Linagliptin 5 mg (milligrams) tablet given by mouth once daily
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
3.3%
4/120 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
6.6%
7/106 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.2%
11/120 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
2.8%
3/106 • 24 weeks (from day of first dose until 7 days after last dose)
Four subjects in each treatment arm were excluded due to site non-compliance issues.
|
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