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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935220
• Other study ID #: 1218.55
• Status: Completed
• Phase: Phase 1
• First received: July 1, 2009
• Last updated: June 17, 2014
• Start date: June 2009

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• linagliptin QD (once daily) for 7 days
dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration

Locations

Country	Name	City	State
United States	1218.55.0005 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	1218.55.0006 Boehringer Ingelheim Investigational Site	Cypress	California
United States	1218.55.0001 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1218.55.0008 Boehringer Ingelheim Investigational Site	Deland	Florida
United States	1218.55.0004 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1218.55.0003 Boehringer Ingelheim Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linagliptin: AUC_t,ss	area under the concentration time curve (AUC_t) of linagliptin in plasma at steady state over a uniform dosing interval	24 hours	No
Primary	Linagliptin: C_max,ss	maximum concentration of linagliptin in plasma at steady state	24 hours	No
Primary	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	No
Secondary	Treatment Emergent Adverse Events	Frequency of patients with AEs	21 days	No
Secondary	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	21 days	No
Secondary	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	21 days	No
Secondary	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	24 hours	No
Secondary	Linagliptin: C_max	maximum concentration of linagliptin in plasma on Day 1	24h	No
Secondary	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.	One single measurement 24 h after drug administration	No

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