A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00813020
First received: December 19, 2008
Last updated: February 20, 2015
Last verified: February 2015
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Purpose
This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: semaglutide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Single Centre, Double-blind, Incomplete Block Trial to Test for Equivalence Between Subcutaneous Injections of the GLP-1 Analogue NN9535 in 1 mg/ml, 3 mg/ml and 10 mg/ml Concentrations in Healthy Male Subject |
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration [ Time Frame: a 28 day time period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cmax of the plasma NN9535 curve [ Time Frame: a 28 day time period ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | January 2009 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 1 administered in equimolar doses
|
| Experimental: B |
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 2 administered in equimolar doses
|
| Experimental: C |
Drug: semaglutide
Comparison of different formulations of the drug, semaglutide: Formulation 3 administered in equimolar doses
Other Name: NN9535
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator
- Body weight between 80 kg and 110 kg (both inclusive)
- Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive
- Fasting plasma glucose max 108 mg/dl (6.0 mmol/l)
Exclusion Criteria:
- Known or suspected allergy to trial product(s) or related products
- Previous participation in this trial (randomisation)
- The receipt of any investigational medicinal product within 3 months prior to this trial
- Subjects who have had a clinically relevant illness within 4 weeks of dosing
- History of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
- Regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813020
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813020
Locations
| Germany | |
| Berlin, Germany, 14050 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00813020 History of Changes |
| Other Study ID Numbers: | NN9535-3679, 2008-004990-17 |
| Study First Received: | December 19, 2008 |
| Last Updated: | February 20, 2015 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015