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

February 12, 2013 updated by: TME Pharma AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • CTC North MediGate GmbH
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Köln, Germany, 50931
        • Itecra GmbH
      • Mainz, Germany, 55116
        • IKFE GmbH
      • Neuss, Germany, D-41460
        • Profil Institut fuer Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Drug: NOX-E36
Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d
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
Experimental: Group B - D
Drug: NOX-E36
Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TME Pharma AG

Collaborators

Profil Institut für Stoffwechselforschung GmbH

Investigators

  • Study Director: Grit Landgraf, PhD, Noxxon AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNOXE36C101
  • 2010-019148-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on NOX-E36

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe