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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01507285
First received: January 5, 2012
Last updated: August 30, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Healthy
Drug: NNC 90-1170
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the Curve [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax, maximum concentration [ Designated as safety issue: No ]
  • tmax, time to maximum concentration [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 1999
Study Completion Date: December 1999
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170 Drug: NNC 90-1170
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
Placebo Comparator: Placebo Drug: placebo
Initial single dose followed by subsequent multiple s.c. (under the skin) doses

  Eligibility

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507285

Locations
United Kingdom
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michael S. Thomsen, MD, PhD 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: NCT01507285     History of Changes
Other Study ID Numbers: NN2211-1189
Study First Received: January 5, 2012
Last Updated: August 30, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014