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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: liraglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761540

NN2211-3533

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 6 patient groups, including a placebo group

A1

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: liraglutide

A2

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

B1

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: liraglutide

B2

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

C1

Experimental group

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: liraglutide

C2

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo