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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: NOX-E36

• Registration Number: NCT01085292
• Lead Sponsor: TME Pharma AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Study Start: 2010-07
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group B - D	NOX-E36	-
Group A	NOX-E36	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus	4 weeks

Secondary Outcome Measures

Name	Time	Method
Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus	4 weeks

Trial Locations

Locations (5)

ikfe GmbH; 🇩🇪 Mainz, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

CTC North MediGate GmbH; 🇩🇪 Hamburg, Germany

Itecra GmbH; 🇩🇪 Köln, Germany

Profil Institut fuer Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany