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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: linagliptin QD (once daily) for 7 days

• Registration Number: NCT00935220
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Primary Completion: 2010-08
• Results First Submitted: 2011-08-22
• Results First Submitted QC: 2011-10-05
• Results First Posted: 2011-11-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
linagliptin	linagliptin QD (once daily) for 7 days	Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation

Primary Outcome Measures

Name	Time	Method
Linagliptin: AUC_τ,ss	24 hours	area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval
Linagliptin: C_max,ss	24 hours	maximum concentration of linagliptin in plasma at steady state
DPP-4 Inhibition: E_24,ss	One single measurement 24 h after drug administration under steady state conditions	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events	21 days	Frequency of patients with AEs
Linagliptin: AUC_0-24	24 hours	area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose
Linagliptin: C_max	24h	maximum concentration of linagliptin in plasma on Day 1
Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event	21 days	Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event
DPP-4 Inhibition: E_24	One single measurement 24 h after drug administration	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.
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities	21 days	12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities

Trial Locations

Locations (6)

1218.55.0004 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1218.55.0008 Boehringer Ingelheim Investigational Site; 🇺🇸 Deland, Florida, United States

1218.55.0006 Boehringer Ingelheim Investigational Site; 🇺🇸 Cypress, California, United States

1218.55.0001 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1218.55.0005 Boehringer Ingelheim Investigational Site; 🇺🇸 Baltimore, Maryland, United States

1218.55.0003 Boehringer Ingelheim Investigational Site; 🇺🇸 New York, New York, United States