Phase 1
Completed N=41
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
Source: ClinicalTrials.gov NCT00935220 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Linagliptin: AUC_τ,ss — 194 nmol*h/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Linagliptin: AUC_τ,ss |
194 | — |
| PRIMARY Linagliptin: C_max,ss |
16.4 | — |
| PRIMARY DPP-4 Inhibition: E_24,ss |
84.7 | — |
| SECONDARY Treatment Emergent Adverse Events |
16; 0; 7; 0 | — |
| SECONDARY Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities |
0; 0; 0; 5 | — |
| SECONDARY Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event |
— | — |
| SECONDARY Linagliptin: AUC_0-24 |
137 | — |
| SECONDARY Linagliptin: C_max |
10.9 | — |
| SECONDARY DPP-4 Inhibition: E_24 |
75.2 | — |
Eligibility Criteria
Inclusion criteria
- Glycosylated haemoglobin >=7 and =21 and =18.5 and 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
Data sourced from ClinicalTrials.gov (NCT00935220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.