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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01319240
First received: March 18, 2011
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Diabetes
Healthy
Drug: insulin degludec
Drug: insulin degludec/liraglutide (A3)
Drug: liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • The area under insulin degludec concentration-time curve [ Time Frame: from 0-infinity hours after trial product administration ] [ Designated as safety issue: No ]
  • The area under liraglutide concentration-time curve [ Time Frame: from 0-infinity hours after trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The area under insulin degludec concentration-time curve [ Time Frame: from 0-120 hours after trial product administration ] [ Designated as safety issue: No ]
  • The area under liraglutide concentration-time curve [ Time Frame: from 0-72 hours after trial product administration ] [ Designated as safety issue: No ]
  • Maximum concentration of insulin degludec [ Time Frame: from 0-120 hours after trial product administration ] [ Designated as safety issue: No ]
  • Maximum concentration of liraglutide [ Time Frame: from 0-72 hours after trial product administration ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: From day 0 to 7-14 days after 3rd trial product administration ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Three-period cross-over 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.
Drug: insulin degludec/liraglutide (A3)
Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319240

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Birgitte Sloth Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01319240     History of Changes
Other Study ID Numbers: NN9068-3871, 2010-021190-36, U1111-1119-2417
Study First Received: March 18, 2011
Last Updated: November 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Insulin, Globin Zinc
Liraglutide
Insulin
Insulin, Long-Acting
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014