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

NCT00935220 | Completed Phase 1 Results

• 1 other identifier: 1218.55
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Linagliptin: AUC_τ,ss

  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

  maximum concentration of linagliptin in plasma at steady state

  24 hours

• 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.

  One single measurement 24 h after drug administration under steady state conditions

Secondary Outcomes (6)

• Treatment Emergent Adverse Events

  21 days

• Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities

  21 days

• Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event

  21 days

• Linagliptin: AUC_0-24

  24 hours

• Linagliptin: C_max

  24h

Study Arms (1)

linagliptin

EXPERIMENTAL

Pharmacokinetic (PK)/Pharmacodynamic (PD) investigation

Drug: linagliptin QD (once daily) for 7 days

Interventions

linagliptin QD (once daily) for 7 days DRUG

dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration

linagliptin

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (6)

1218.55.0006 Boehringer Ingelheim Investigational Site

Cypress, California, United States

Location

1218.55.0008 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1218.55.0004 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1218.55.0005 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1218.55.0003 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1218.55.0001 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 8, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: November 10, 2011

Record last verified: 2014-02

Locations

US (6)