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

TME Pharma AG47 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Itecra GmbH

Cologne, Germany

CTC North MediGate GmbH

Hamburg, Germany

Medizinische Hochschule Hannover

Hanover, Germany

ikfe GmbH

Mainz, Germany

Profil Institut fuer Stoffwechselforschung GmbH

Neuss, Germany

Outcomes

Primary Outcomes

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 Outcomes

Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus

Time frame: 4 weeks