Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
linagliptin QD (once daily) for 7 days
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
- 1218.55.0006 Boehringer Ingelheim Investigational Site
- 1218.55.0008 Boehringer Ingelheim Investigational Site
- 1218.55.0004 Boehringer Ingelheim Investigational Site
- 1218.55.0005 Boehringer Ingelheim Investigational Site
- 1218.55.0003 Boehringer Ingelheim Investigational Site
- 1218.55.0001 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
linagliptin
Arm Description
Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
Outcomes
Primary Outcome Measures
Linagliptin: AUC_τ,ss
area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval
Linagliptin: C_max,ss
maximum concentration of linagliptin in plasma at steady state
DPP-4 Inhibition: E_24,ss
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
Treatment Emergent Adverse Events
Frequency of patients with AEs
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities
Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event
Linagliptin: AUC_0-24
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
maximum concentration of linagliptin in plasma on Day 1
DPP-4 Inhibition: E_24
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00935220
Brief Title
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
linagliptin
Arm Type
Experimental
Arm Description
Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
Intervention Type
Drug
Intervention Name(s)
linagliptin QD (once daily) for 7 days
Intervention Description
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration
Primary Outcome Measure Information:
Title
Linagliptin: AUC_τ,ss
Description
area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval
Time Frame
24 hours
Title
Linagliptin: C_max,ss
Description
maximum concentration of linagliptin in plasma at steady state
Time Frame
24 hours
Title
DPP-4 Inhibition: E_24,ss
Description
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.
Time Frame
One single measurement 24 h after drug administration under steady state conditions
Secondary Outcome Measure Information:
Title
Treatment Emergent Adverse Events
Description
Frequency of patients with AEs
Time Frame
21 days
Title
Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities
Description
12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities
Time Frame
21 days
Title
Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event
Description
Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event
Time Frame
21 days
Title
Linagliptin: AUC_0-24
Description
area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose
Time Frame
24 hours
Title
Linagliptin: C_max
Description
maximum concentration of linagliptin in plasma on Day 1
Time Frame
24h
Title
DPP-4 Inhibition: E_24
Description
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.
Time Frame
One single measurement 24 h after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1218.55.0006 Boehringer Ingelheim Investigational Site
City
Cypress
State/Province
California
Country
United States
Facility Name
1218.55.0008 Boehringer Ingelheim Investigational Site
City
Deland
State/Province
Florida
Country
United States
Facility Name
1218.55.0004 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1218.55.0005 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1218.55.0003 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1218.55.0001 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.55_U11-3076-01_DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.55_Literature.pdf
Description
Related Info
Learn more about this trial
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
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