Comparison of Three Liraglutide Formulations in Healthy Volunteers

NCT01514487 | Completed Phase 1

• 1 other identifier: NN2211-1636
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the Curve (0-t)

• Cmax, maximum concentration

Secondary Outcomes (5)

• Area under the curve (0-infinity)

• tmax, time to reach Cmax

• t½, terminal half-life

• Terminal elimination rate constant

• Adverse events

Study Arms (3)

pH 7.7

EXPERIMENTAL

Drug: liraglutide

pH 7.9

EXPERIMENTAL

Drug: liraglutide

pH 8.15

EXPERIMENTAL

Drug: liraglutide

Interventions

liraglutide DRUG

One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously

pH 7.7; pH 7.9; pH 8.15

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects
• Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments.
• Body Mass Index (BMI) of 18-27 kg/m\^2, both inclusive

You may not qualify if:

• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal,
• metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders
• that may interfere with the objectives of the study, as judged by the investigator
• Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
• Impaired renal function
• Uncontrolled treated/untreated hypertension
• Any clinically significant abnormal ECG
• Active hepatitis B and/or active hepatitis C
• Positive HIV (human immunideficiency virus) antibodies
• Known or suspected allergy to trial product(s) or related products
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
• Prescription or non-prescription medication, except for paracetamol and vitamins
• History of alcoholism or drug abuse during the last 12 months
• Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
• Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Adelaide, 5000, Australia

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 23, 2012
• Study Start: January 13, 2005
• Primary Completion: March 30, 2005
• Study Completion: March 30, 2005
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

AU (1)