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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00935220
First received: July 1, 2009
Last updated: June 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: linagliptin QD (once daily) for 7 days
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Linagliptin: AUC_τ,ss [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval

  • Linagliptin: C_max,ss [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    maximum concentration of linagliptin in plasma at steady state

  • DPP-4 Inhibition: E_24,ss [ Time Frame: One single measurement 24 h after drug administration under steady state conditions ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Frequency of patients with AEs

  • Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event

  • Linagliptin: AUC_0-24 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24h ] [ Designated as safety issue: No ]
    maximum concentration of linagliptin in plasma on Day 1

  • DPP-4 Inhibition: E_24 [ Time Frame: One single measurement 24 h after drug administration ] [ Designated as safety issue: No ]
    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.


Enrollment: 41
Study Start Date: June 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: linagliptin
Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation
Drug: linagliptin QD (once daily) for 7 days
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935220

Locations
United States, California
1218.55.0006 Boehringer Ingelheim Investigational Site
Cypress, California, United States
United States, Florida
1218.55.0008 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
1218.55.0004 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
United States, Maryland
1218.55.0005 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, New York
1218.55.0003 Boehringer Ingelheim Investigational Site
New York, New York, United States
United States, Texas
1218.55.0001 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00935220     History of Changes
Other Study ID Numbers: 1218.55
Study First Received: July 1, 2009
Results First Received: August 22, 2011
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
BI 1356
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014