A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects
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ClinicalTrials.gov Identifier: NCT00813020 |
Recruitment Status :
Completed
First Posted : December 22, 2008
Last Update Posted : February 23, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 2 | Drug: semaglutide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |
Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- Cmax of the plasma NN9535 curve [ Time Frame: a 28 day time period ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813020
Germany | |
Berlin, Germany, 14050 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00813020 |
Other Study ID Numbers: |
NN9535-3679 2008-004990-17 ( EudraCT Number ) |
First Posted: | December 22, 2008 Key Record Dates |
Last Update Posted: | February 23, 2015 |
Last Verified: | February 2015 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |