Phase 1
Completed N=31
Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
Diabetes · Type 2 Diabetes Mellitus · Healthy
Source: ClinicalTrials.gov NCT01473953 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: Number of Treatment Emergent Adverse Events (TEAEs) — 3; 3; 4; 21 events
Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events (TEAEs) |
3; 3; 4; 21; 13; 0 | — |
| SECONDARY Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot |
690; 2141; 6977; 40041 | — |
| SECONDARY Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot |
15.13; 8.09; 13.74; 10.46 | — |
| SECONDARY Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity |
43840; 116935; 360000; 1443038 | — |
| SECONDARY Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment |
37298; 114101; 316642; 1363187 | — |
| SECONDARY Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment |
— | — |
| SECONDARY Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up |
0; 0; 0; 0; 0; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) between 20 and 35 kg/m^2 (both inclusive) with a body weight of at least 60 kg
- Apart from being obese (BMI above 30 kg/m^2) the subject has to be considered generally healthy
Exclusion Criteria
- Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
- Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy
- Prescription medicine and non-prescription medicine with few exceptions
- Current and prior history of alcohol or drug abuse
- Current smoking of more than 5 cigarettes per day
- Mental incapacity, language barriers, or unwillingness to comply with the protocol
Data sourced from ClinicalTrials.gov (NCT01473953). 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.