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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:
Collaborator:
Profil Institut für Stoffwechselforschung GmbH
Information provided by (Responsible Party):
Noxxon Pharma AG
ClinicalTrials.gov Identifier:
NCT01085292
First received: March 10, 2010
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Noxxon Pharma AG
ClinicalTrials.gov Identifier: NCT01085292     History of Changes
Other Study ID Numbers: SNOXE36C101, 2010-019148-38
Study First Received: March 10, 2010
Last Updated: February 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013