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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00935220
• Date of registration: 01/07/2009
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals
• Public title: Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
• Scientific 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
• Date of first enrolment: June 2009
• Target sample size: 41
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00935220
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: linagliptin QD (once daily) for 7 days

Primary Outcome(s)

DPP-4 Inhibition: E_24,ss [Time Frame: One single measurement 24 h after drug administration under steady state conditions]

Linagliptin: AUC_t,ss [Time Frame: 24 hours]

Linagliptin: C_max,ss [Time Frame: 24 hours]

Secondary Outcome(s)

DPP-4 Inhibition: E_24 [Time Frame: One single measurement 24 h after drug administration]

Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities [Time Frame: 21 days]

Linagliptin: AUC_0-24 [Time Frame: 24 hours]

Linagliptin: C_max [Time Frame: 24h]

Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event [Time Frame: 21 days]

Treatment Emergent Adverse Events [Time Frame: 21 days]

Secondary ID(s)

1218.55

Source(s) of Monetary Support

Please refer to primary and secondary sponsors