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

TME Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: NOX-E36

Study type

Interventional

Funder types

Industry

Identifiers

NCT01085292

SNOXE36C101

2010-019148-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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