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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 February 2013 |
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Main ID: |
NCT01085292 |
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Date of registration:
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10/03/2010 |
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Primary sponsor: |
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Public title:
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NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
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Scientific title:
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NOX-E36 - A Phase Ib, Multiple Intravenous Dose Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties in Healthy Subjects and Then in Three Groups of Patients With Type 2 Diabetes Mellitus to Compare Three Ascending Dose Regimens in a Double-blind and Placebo-controlled Manner |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01085292 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Grit Landgraf, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Noxxon AG |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Group A: Healthy male and female subjects
- Group B-D: Patients with type 2 diabetes mellitus according to ADA definition; GFR >
60 mL/min; HbA1c = 6.0 and =9.0 %; normoalbuminuria, microalbuminuria or
macroalbuminuria
Exclusion Criteria:
- History of or presence of clinically significant diseases with the exception of
diabetes (Groups B-D)
- Concurrent illness that may affect blood glucose other than diabetes
- Supine blood pressure at screening, after resting for 5 min, of >140 mmHg systolic or
> 90 mmHg diastolic (Group A) or > 160 mmHg systolic or > 95 mmHg in diabetes
mellitus patients (Groups B-D)
- Clinically significant abnormal ECG at screening
- Any kidney disease not caused by diabetes or hypertension
- Type 1 diabetes mellitus
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: NOX-E36
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Primary Outcome(s)
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Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus
[Time Frame: 4 weeks]
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Secondary ID(s)
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2010-019148-38
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SNOXE36C101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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