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

NCT01319240 | Completed Phase 1

• 3 other identifiers: NN9068-38712010-021190-36U1111-1119-2417
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (3)

IDegLira

EXPERIMENTAL

Drug: insulin degludec/liraglutide

IDeg

ACTIVE COMPARATOR

Drug: insulin degludec

Lira

ACTIVE COMPARATOR

Drug: liraglutide

Interventions

insulin degludec DRUG

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

IDeg

insulin degludec/liraglutide DRUG

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

IDegLira

liraglutide DRUG

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

Lira

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec; IDegLira; 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: March 18, 2011
• First Posted: March 21, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

DE (1)