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NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085292
First Posted: March 11, 2010
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Profil Institut für Stoffwechselforschung GmbH
Information provided by (Responsible Party):
NOXXON Pharma AG
  Purpose
The primary objective of this trial is to evaluate the safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus. A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic response at the level of inflammation, metabolism as well as ongoing diabetes complications (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to provide sufficient safety and dose-response data for a planned Phase IIa proof of concept study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: NOX-E36 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NOXXON Pharma AG:

Primary Outcome Measures:
  • Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus [ Time Frame: 4 weeks ]

Enrollment: 47
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: NOX-E36
Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d
Experimental: Group B - D Drug: NOX-E36
Multiple dose of 0.0625 mg/kg, 0.125 mg/kg, 0.25 mg/kg or placebo i.v. to patients with type 2 diabetes mellitus (ratio 3:1); dosing frequency q2d

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01085292


Locations
Germany
CTC North MediGate GmbH
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Itecra GmbH
Köln, Germany, 50931
ikfe GmbH
Mainz, Germany, 55116
Profil Institut fuer Stoffwechselforschung GmbH
Neuss, Germany, D-41460
Sponsors and Collaborators
NOXXON Pharma AG
Profil Institut für Stoffwechselforschung GmbH
Investigators
Study Director: Grit Landgraf, PhD Noxxon AG
  More Information

Responsible Party: NOXXON Pharma AG
ClinicalTrials.gov Identifier: NCT01085292     History of Changes
Other Study ID Numbers: SNOXE36C101
2010-019148-38 ( EudraCT Number )
First Submitted: March 10, 2010
First Posted: March 11, 2010
Last Update Posted: February 13, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases