To Investigate the Blood Concentration of Liraglutide as Well as the Effects on Glucose and Insulin After 21 Days of Daily Subcutaneous Injections of Liraglutide or Placebo

Study Overview
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Brief Summary
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This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. In addition, the safety and tolerability of liraglutide will be observed.

Official Title
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A Dose Escalation Study to Investigate the Pharmacokinetics, Tolerability and Safety of Liraglutide After Multiple s.c. Doses in Healthy Chinese Male Subjects

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo
* Drug: liraglutide
* Drug: placebo
* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any trial related activities Healthy Chinese male subjects Body mass index (BMI) between 19.0 and 27.0 kg/m2 (both inclusive) Fasting plasma glucose less than 6.0 mmol/L Non-smoker Exclusion Criteria: Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor) Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90- 140 mmHg systolic and/or 40 - 90 mmHg diastolic Pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min Hepatitis B surface antigen, Hepatitis C antibodies or HIV antibodies positive.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: liraglutide<br>* Liraglutide for s.c. injection once daily: dose step 1 (9 subjects)<br>|
| Placebo Comparator: A2<br> | Drug: placebo<br>* Liraglutide placebo for s.c. injection once daily: dose step 1 (3 subjects)<br>|
| Experimental: B1<br> | Drug: liraglutide<br>* Liraglutide for s.c. injection once daily: dose step 1, followed by dose step 2 (9 subjects)<br>|
| Placebo Comparator: B2<br> | Drug: placebo<br>* Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose step 2 (3 subjects)<br>|
| Experimental: C1<br> | Drug: liraglutide<br>* Liraglutide for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (9 subjects)<br>|
| Placebo Comparator: C2<br> | Drug: placebo<br>* Liraglutide placebo for s.c. injection once daily: dose step 1, followed by dose steps 2 and 3 (3 subjects)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-24h (last dosing day): Area under the plasma liraglutide curve from 0 to 24 hours after last dosing. |  | After 21 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-24h: Area under the plasma liraglutide curve from 0 to 24 hours after first dosing, AUC0-24h (Day 1) |  | After 1 day of treatment | 
| Adverse events |  | After 21 days of treatment | 
| Hypoglycaemic events |  | After 21 days of treatment |