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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Group Type EXPERIMENTAL

NOX-E36

Intervention Type DRUG

Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d

Group B - D

Group Type EXPERIMENTAL

NOX-E36

Intervention Type DRUG

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

Interventions

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NOX-E36

Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d

Intervention Type 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

Intervention Type DRUG

Eligibility 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes