- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00935220
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
Conditions
Intervention / Treatment
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
-
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California
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Cypress, California, United States
- 1218.55.0006 Boehringer Ingelheim Investigational Site
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Florida
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Deland, Florida, United States
- 1218.55.0008 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
- 1218.55.0004 Boehringer Ingelheim Investigational Site
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Maryland
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Baltimore, Maryland, United States
- 1218.55.0005 Boehringer Ingelheim Investigational Site
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New York
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New York, New York, United States
- 1218.55.0003 Boehringer Ingelheim Investigational Site
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Texas
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Dallas, Texas, United States
- 1218.55.0001 Boehringer Ingelheim Investigational Site
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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:
- Glycosylated haemoglobin >=7 and <= 10%
- Age >=21 and <= 65
- Body Mass Index >=18.5 and <=38 kg/m2
- African American origin
- Signed and dated informed consent prior to admission to the study
Exclusion criteria:
- Any finding of the medical examination considered clinically relevant by the Investigator
- 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).
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
- Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
- Diagnosis of sickle cell anemia or known chronic anemia
- History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)
- History of relevant allergy/hypersensitivity
- 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
- Alcohol abuse, drug abuse
- Any laboratory value of clinical relevance that is outside an acceptable range
- Change of drug dosing of allowed co medication
- Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.
- Fasted glucose >270 mg/dl or randomly determined blood glucose >400 mg/dl on two consecutive days during screening or wash out
- 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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Emergent Adverse Events
Time Frame: 21 days
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Frequency of patients with AEs
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21 days
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Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
Time Frame: 21 days
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12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities
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21 days
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Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
Time Frame: 21 days
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Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event
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21 days
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Linagliptin: AUC_0-24
Time Frame: 24 hours
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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
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Linagliptin: C_max
Time Frame: 24h
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maximum concentration of linagliptin in plasma on Day 1
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24h
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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.
Sponsor
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.
Helpful Links
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
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Linagliptin
Other Study ID Numbers
- 1218.55
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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