Safety and Tolerability of Insulin Degludec/Liraglutide (A3) in Healthy Subjects

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01319240

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the bioavailability of insulin degludec and liraglutide, when administered either combined or as separate administrations.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Healthy	Drug: insulin degludec Drug: insulin degludec/liraglutide 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 Trial to Investigate Pharmacokinetics, Safety and Tolerability of Insulin Degludec/Liraglutide (A3) Compared With Insulin Degludec and Liraglutide in Healthy Subjects

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDegLira	Drug: insulin degludec/liraglutide Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
Active Comparator: IDeg	Drug: insulin degludec Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
Active Comparator: Lira	Drug: liraglutide Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.

Arm

Intervention/Treatment

Experimental: IDegLira

Drug: insulin degludec/liraglutide

Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.

Active Comparator: IDeg

Drug: insulin degludec

Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.

Active Comparator: Lira

Drug: liraglutide

Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.

Outcome Measures

Primary Outcome Measures

The area under insulin degludec concentration-time curve [from 0-infinity hours after trial product administration]
The area under liraglutide concentration-time curve [from 0-infinity hours after trial product administration]

Secondary Outcome Measures

The area under insulin degludec concentration-time curve [from 0-120 hours after trial product administration]
The area under liraglutide concentration-time curve [from 0-72 hours after trial product administration]
Maximum concentration of insulin degludec [from 0-120 hours after trial product administration]
Maximum concentration of liraglutide [from 0-72 hours after trial product administration]
Number of hypoglycaemic episodes [From day 0 to 7-14 days after 3rd trial product administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Body Mass Index (BMI) between 20.0 and 27.0 kg/m^2 (both inclusive)
Body weight between 75 kg and 90 kg (both inclusive)
Fasting plasma glucose below 6.1 mmol/L (110 mg/dL)

Exclusion Criteria:

Known or suspected hypersensitivity to trial products or related products
Previous participation in this trial. Participation is defined as randomised
Previous participation in any other clinical trial involving other investigational products within the last 3 months before dosing in this trial
Donation of any blood or plasma in the past month or in excess of 500 mL within the 3 month preceding screening (trial start) or surgery or trauma with more than 500 mL blood loss within the 3 month preceding screening
History of or presence of cancer, or any clinically significant cardiovascular, respiratory,metabolic, renal, hepatic, gastrointestinal, endocrine, diabetes, haematological, dermatological,venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial, as judged by the Investigator (Trial Physician)
Clinically significant abnormal haematology, biochemistry, lipids, urinalysis or coagulation screening tests, as judged by the Investigator (Trial Physician)
Known hepatitis or known carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C antibodies, or a positive result to the test for HIV (human immunodeficiency virus) antibodies and antigen
Family or personal history of MEN2 (Multiple endocrine neoplasia syndrome type 2) or familial medullary thyroid carcinoma (FMTC)
History of chronic pancreatitis or idiopathic acute pancreatitis
Supine blood pressure at screening, after resting for 5 min, outside the range of 90-140 mmHg systolic or 50-90 mmHg diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the subject can be included in the trial) or resting heart rate outside the range of 40-90 bpm
Clinically significant abnormal ECG (Electrocardiogram) at screening (trial start)
Significant history of alcoholism or drug/chemical abuse, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits)
Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods
Mental incapacity or language barriers which preclude adequate understanding or cooperation,unwillingness to participate in the trial or subjects that in the opinion of Investigator (trial physician) should not participate in the trial
Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, and vitamins (but including mega-dose vitamin therapy, as judged by the Investigator (trial physician)) within 2 weeks before the trial
Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator (trial physician)
Subjects with a history of deep leg vein thrombosis or with frequent appearance of deep leg vein thrombosis in 1st degree relatives as judged by the Investigator (trial physician)
Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
Baseline (screening) calcitonin level above or equal to 50 ng/L
Suffer from a life threatening disease