Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients (NCT NCT00935220)

NCT ID: NCT00935220

Last Updated: 2014-06-27

Results Overview

area under the concentration time curve (AUC\_τ) of linagliptin in plasma at steady state over a uniform dosing interval

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 41 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2014-06-27

Participant Flow

Participant milestones

Measure	Linagliptin 5mg Linagliptin 5mg once daily
Overall Study STARTED	41
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Linagliptin 5mg Linagliptin 5mg once daily
Overall Study Adverse Event	1
Overall Study Other reason (not specified)	1

Baseline Characteristics

Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients

Baseline characteristics by cohort

Measure	Linagliptin 5mg n=41 Participants Linagliptin 5mg once daily
Age, Continuous	50.5 Years STANDARD_DEVIATION 9.8 • n=113 Participants
Sex: Female, Male Female	19 Participants n=113 Participants
Sex: Female, Male Male	22 Participants n=113 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=113 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=113 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Race/Ethnicity, Customized Black / African American	41 Participants n=113 Participants
Body mass index (BMI) continuous	30.93 kg/m^2 STANDARD_DEVIATION 3.90 • n=113 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Treated set

area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval

Outcome measures

Measure	Linagliptin 5mg n=39 Participants Linagliptin 5mg once daily
Linagliptin: AUC_τ,ss	194 nmol*h/L Geometric Coefficient of Variation 25.8

PRIMARY outcome

Timeframe: 24 hours

Population: Treated set

maximum concentration of linagliptin in plasma at steady state

Outcome measures

Measure	Linagliptin 5mg n=39 Participants Linagliptin 5mg once daily
Linagliptin: C_max,ss	16.4 nmol/L Geometric Coefficient of Variation 40.9

PRIMARY outcome

Timeframe: One single measurement 24 h after drug administration under steady state conditions

Population: Treated set

Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.

Outcome measures

Measure	Linagliptin 5mg n=37 Participants Linagliptin 5mg once daily
DPP-4 Inhibition: E_24,ss	84.7 Percent (of inhibition) Interval 72.2 to 91.9

SECONDARY outcome

Timeframe: 21 days

Population: All treated patients

Frequency of patients with AEs

Outcome measures

Measure	Linagliptin 5mg n=41 Participants Linagliptin 5mg once daily
Treatment Emergent Adverse Events Patients with any adverse events (AEs)	16 Participants
Treatment Emergent Adverse Events Patients with severe AEs	0 Participants
Treatment Emergent Adverse Events Patients with drug-related AEs	7 Participants
Treatment Emergent Adverse Events Discontinuation due to AEs	0 Participants

SECONDARY outcome

Timeframe: 21 days

Population: All treated patients

12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities

Outcome measures

Measure	Linagliptin 5mg n=41 Participants Linagliptin 5mg once daily
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities ECG abnormalities	0 Participants
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Vital signs abnormalities	0 Participants
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Physical finding abnormalities	0 Participants
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Laboratory finding abnormalities	5 Participants

SECONDARY outcome

Timeframe: 21 days

Population: All treated patients

Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event

Outcome measures

Measure	Linagliptin 5mg n=41 Participants Linagliptin 5mg once daily
Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event	0 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: Treated set- All patients with values for the area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose (AUC\_0-24) for Linagliptin

area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose

Outcome measures

Measure	Linagliptin 5mg n=41 Participants Linagliptin 5mg once daily
Linagliptin: AUC_0-24	137 nmol*h/L Geometric Coefficient of Variation 32.4

SECONDARY outcome

Timeframe: 24h

Population: Treated set - All patients with values for the maximum measured concentration of linagliptin in plasma (C\_max)

maximum concentration of linagliptin in plasma on Day 1

Outcome measures

Measure	Linagliptin 5mg n=41 Participants Linagliptin 5mg once daily
Linagliptin: C_max	10.9 nmol/L Geometric Coefficient of Variation 57.6

SECONDARY outcome

Timeframe: One single measurement 24 h after drug administration

Population: Treated set

Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.

Outcome measures

Measure	Linagliptin 5mg n=39 Participants Linagliptin 5mg once daily
DPP-4 Inhibition: E_24	75.2 Percent (of inhibition) Interval 52.0 to 89.8

Adverse Events

Linagliptin 5mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Linagliptin 5mg n=41 participants at risk Linagliptin 5mg once daily
Nervous system disorders Headache	12.2% 5/41 • 7 days

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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