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

June 17, 2014 updated by: Boehringer Ingelheim

An Open Label, Phase I Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Linagliptin (BI 1356) 5 mg After Single and Multiple Oral Administration in Patients With Type 2 Diabetes Mellitus of African American Origin for 7 Days

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Cypress, California, United States
        • 1218.55.0006 Boehringer Ingelheim Investigational Site
    • Florida
      • Deland, Florida, United States
        • 1218.55.0008 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1218.55.0004 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1218.55.0005 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, United States
        • 1218.55.0003 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1218.55.0001 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Glycosylated haemoglobin >=7 and <= 10%
  2. Age >=21 and <= 65
  3. Body Mass Index >=18.5 and <=38 kg/m2
  4. African American origin
  5. Signed and dated informed consent prior to admission to the study

Exclusion criteria:

  1. Any finding of the medical examination considered clinically relevant by the Investigator
  2. Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease including hypertension >160-100 mmHg (under current treatment), stroke and transient ischemic attack (TIA).
  3. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
  4. Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
  5. Diagnosis of sickle cell anemia or known chronic anemia
  6. History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)
  7. History of relevant allergy/hypersensitivity
  8. Intake of drugs with a long half life (>24hours) within at least one month or less than 10 half lives of the respective drug prior to administration except allowed co medication
  9. Alcohol abuse, drug abuse
  10. Any laboratory value of clinical relevance that is outside an acceptable range
  11. Change of drug dosing of allowed co medication
  12. Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.
  13. Fasted glucose >270 mg/dl or randomly determined blood glucose >400 mg/dl on two consecutive days during screening or wash out
  14. Serum creatinine above upper limit normal at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: linagliptin
Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

February 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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