Comparison of Three Liraglutide Formulations in Healthy Volunteers

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01514487
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 9.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Healthy	Drug: liraglutide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the 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
• Actual Study Start Date: Jan 13, 2005
• Actual Primary Completion Date: Mar 30, 2005
• Actual Study Completion Date: Mar 30, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pH 7.7	Drug: liraglutide; 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
Experimental: pH 7.9	Drug: liraglutide; 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
Experimental: pH 8.15	Drug: liraglutide; 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

Outcome Measures

Primary Outcome Measures

1. Area under the Curve (0-t) []

2. Cmax, maximum concentration []

Secondary Outcome Measures

1. Area under the curve (0-infinity) []

2. tmax, time to reach Cmax []

3. t½, terminal half-life []

4. Terminal elimination rate constant []

5. Adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Adelaide		Australia	5000

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01514487
• Other Study ID Numbers: NN2211-1636
• First Posted: Jan 23, 2012
• Last Update Posted: Mar 1, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Liraglutide

Study Results

No Results Posted as of Mar 1, 2017