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Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01507285
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
3
Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after single and multiple doses of NNC 90-1170 (liraglutide) in healthy volunteers and in subjects with type 2 diabetes.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Placebo-controlled, Dose-escalation, Parallel-group, Single and Multiple Dosing Trial of NN90-1170 in Healthy Volunteers and Patients With Type 2 Diabetes to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
Study Start Date :
Aug 1, 1999
Actual Primary Completion Date :
Nov 1, 1999
Actual Study Completion Date :
Nov 1, 1999

Arms and Interventions

Arm Intervention/Treatment
Experimental: NNC 90-1170

Drug: liraglutide
Initial single dose followed by subsequent multiple s.c. (under the skin) doses on several dose levels (1.25, 5, 7.5, 10 and 12.5 mcg/kg). Each subject will be allocated to one dose level only
Other Names:
  • NNC 90-1170

    		•
    Placebo Comparator: Placebo

    Drug: placebo
    Initial single dose followed by subsequent multiple s.c. (under the skin) doses

    Outcome Measures

    Primary Outcome Measures

    1. Area under the Curve []

    Secondary Outcome Measures

    1. Cmax, maximum concentration []

    2. tmax, time to maximum concentration []

    3. t½, terminal half-life []

    4. Adverse events []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • HEALTHY VOLUNTEERS

    • Healthy subjects aged 18-45 years inclusive

    • Healthy subjects are defined as individuals free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and clinical laboratory test results

    • Women who are not of childbearing potential

    • Signed and dated written informed consent obtained

    • Body mass index (BMI) within the range 19-30 kg/m^2, inclusive

    • SUBJECTS WITH DIABETES

    • Subjects aged 40-70 years inclusive

    • Subjects diagnosed with type-2 diabetes and a duration of diabetes of more than 12 months

    • Women who are not of childbearing potential

    • Signed and dated written informed consent obtained

    • Fasting C-peptide at least 0.3 nmol/l and blood glucose at least 7 mmol/l

    • Subjects currently on diet and/or OHA (oral hypoglycemic agents) for at least six months

    • Body mass index (BMI) below 35 kg/m^2

    • HbA1c (glycosylated haemoglobin) below 11%

    • Stable on current medication for at least 3 weeks prior to dosing in this study

    Exclusion Criteria:

    • HEALTHY VOLUNTEERS

    • Clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation

    • Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation

    • Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous

    • Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-150 mmHg systolic, 40-90 mmHg diastolic: heart rate 40-100 beats/min

    • History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women)

    • Alcohol intake within 48 hours prior to visit

    • Evidence of drug abuse on urine testing at study entry

    • The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period

    • Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies

    • History of significant drug allergy or drug hypersensitivity

    • SUBJECTS WITH DIABETES

    • Use of any drug (except for oral hypoglycaemic agents (OHAs)) which in the Investigator's opinion could interfere with the blood glucose level (e.g. insulin, systemic corticosteroids, thiazides)

    • Recurrent severe hypoglycaemia as judged by the Investigator

    • Clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation

    • Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation

    • Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous

    • Blood pressure and heart rate in seated position at the screening examination outside the ranges 110-160 mmHg systolic, 60-90 mmHg diastolic: heart rate 40-100 beats/min

    • History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women)

    • Alcohol intake within 48 hours of visit

    • Evidence of drug abuse on urine testing at study entry

    • The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period

    • Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies

    • History of significant drug allergy or drug hypersensitivity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Manchester United Kingdom M15 6SH

    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:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT01507285
    Other Study ID Numbers:
    • NN2211-1189
    First Posted:
    Jan 10, 2012
    Last Update Posted:
    Jan 24, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Liraglutide

    Study Results

    No Results Posted as of Jan 24, 2017