A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects

Novo Nordisk A/S1 site in 1 country58 target enrollmentJune 11, 2007

ConditionsDiabetes Diabetes Mellitus, Type 2 Healthy

Interventionssemaglutide Placebo

Drugssemaglutide Placebo

Overview

Phase: Phase 1
Intervention: semaglutide
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 58
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability of ascending single s.c. doses of NNC 0113-0217 in healthy male subjects, aiming at establishing the Maximum Tolerated Dose (MTD)

Registry

clinicaltrials.gov

Start Date

June 11, 2007

End Date

October 8, 2007

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
•Subject is male
•Age 18-65 years, both included
•Body Mass Index (BMI) below 35.0 kg/m\^2 (Body weight between 50 kg -150 kg, both inclusive)
•Good general health based on medical history, physical examination including ECG (Electrocardiogram) and laboratory analysis, as judged by the investigator

Exclusion Criteria

•Previous participation, defined as randomised, in any other clinical trial involving this or other investigational products within the last 3 months before dosing
•Patients with MI (Myocardia-Infarction) during the last 12 month
•Patients receiving ACE (Angiotensin-Converting Enzyme) inhibitors, beta-blockers, thiazide diuretics, thyroid hormones, and/or lipid lowering medication who are not on a stable dose for more than 6 weeks prior to start of the study
•Use of weight lowering medications (orlistat, sibutramine, rimonabant, phentermine)
•Clinically significant GI (Gastro-Intestinal) disease including inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia, apparent diabetic gastro paresis, diabetic diarrhoea, or surgery of the gastro-intestinal tract (except appendectomy and cholecystectomy)
•Subjects who are sexually active and have not been surgically sterilised must be informed that they and their partner use a highly effective method of contraception (Pearl Index below 1%) such as implants, injectables, combined oral contraceptives, or hormonal IUDs (intrauterine devices), or refrain from sexual intercourse during the study and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by study medication
•Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers, and MAO (Mono-Amino-Oxidase) inhibitors
•Subjects who drink more than 8 cups of tea/coffee per day
•History of drug or alcohol abuse (defined as intake of more than 28 units weekly - 1 unit = 12 oz or 360 ml of beer; 5 oz ir 150 ml of wine; 1.5 oz or 45 ml of distilled spirits)
•Alcohol intake within 48 hours prior to dosing

Arms & Interventions

NNC 0113-0217

Dose-escalation trial

Intervention: semaglutide

Placebo

Dose-escalation trial

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: After 24-33 days

Secondary Outcomes

Area under the curve of NNC 0113-0217(From 0-168 hours after dosing)
Morning fasting plasma glucose(At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19))
Morning fasting insulin(At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19))
Morning fasting glucagon(At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19))