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

NCT01507285 | Completed Phase 1

• 1 other identifier: NN2211-1189
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the Curve

Secondary Outcomes (4)

• Cmax, maximum concentration

• tmax, time to maximum concentration

• t½, terminal half-life

• Adverse events

Study Arms (2)

NNC 90-1170

EXPERIMENTAL

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutide DRUG

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

Also known as: NNC 90-1170

NNC 90-1170

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Manchester, M15 6SH, United Kingdom

Location

Related Publications (1)

• Agerso H, Jensen LB, Elbrond B, Rolan P, Zdravkovic M. The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men. Diabetologia. 2002 Feb;45(2):195-202. doi: 10.1007/s00125-001-0719-z.

  PMID: 11935150 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 10, 2012
• Study Start: August 1, 1999
• Primary Completion: November 1, 1999
• Study Completion: November 1, 1999
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

GB (1)