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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United Kingdom

Start
Aug 1999
Primary completion
Nov 1999
Completion
Nov 1999
First posted
10 Jan 2012 (estimated)
Last update posted
2 Nov 2023
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
19992000
  1. Ph 1

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

    NCT01507285

    Aug 1999 to Nov 1999

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    NNC 90-1170

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the Curve

Secondary outcomes(4)
  1. Cmax, maximum concentration

  2. tmax, time to maximum concentration

  3. t½, terminal half-life

  4. Adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2002

17 results

The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men.

Agersø et al. 2002Diabetologiacited by 391

PMID 11935150DOI 10.1007/s00125-001-0719-zPUB-11935150

Rights unknown17 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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