Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes
October 31, 2023 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manchester, United Kingdom, M15 6SH
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Initial single dose followed by subsequent multiple s.c.
(under the skin) doses
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Experimental: NNC 90-1170
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Area under the Curve
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
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Cmax, maximum concentration
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t½, terminal half-life
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tmax, time to maximum concentration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1999
Primary Completion (Actual)
November 1, 1999
Study Completion (Actual)
November 1, 1999
Study Registration Dates
First Submitted
January 5, 2012
First Submitted That Met QC Criteria
January 6, 2012
First Posted (Estimated)
January 10, 2012
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN2211-1189
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