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CompletedNCT01319240Updated Oct 2, 2015

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

A Phase 1 interventional study of insulin degludec and insulin degludec/liraglutide in Diabetes and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Diabetes
  • Healthy
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    IDegLira

    Drug: insulin degludec/liraglutide

  • Active comparator
    IDeg

    Drug: insulin degludec

  • Active comparator
    Lira

    Drug: liraglutide

Interventions

  • Druginsulin 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.

  • Druginsulin 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.

  • Drugliraglutide

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

06

What researchers measure

Primary outcomes

  1. The area under insulin degludec concentration-time curve

    Time frame: from 0-infinity hours after trial product administration

  2. The area under liraglutide concentration-time curve

    Time frame: from 0-infinity hours after trial product administration

Secondary outcomes

  1. The area under insulin degludec concentration-time curve

    Time frame: from 0-120 hours after trial product administration

  2. The area under liraglutide concentration-time curve

    Time frame: from 0-72 hours after trial product administration

  3. Maximum concentration of insulin degludec

    Time frame: from 0-120 hours after trial product administration

  4. Maximum concentration of liraglutide

    Time frame: from 0-72 hours after trial product administration

  5. Number of hypoglycaemic episodes

    Time frame: From day 0 to 7-14 days after 3rd trial product administration

07

Study locations

1 site
  • Neuss, 41460, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01319240
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Mar 21, 2011
Start date
Mar 2011
Primary completion
May 2011
Completion
May 2011
Last update
Oct 2, 2015

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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