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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01085292

Enrollment

Registered

2010-03-11

Start date

2010-07-31

Completion date

2012-02-29

Last updated

2013-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

DRUGNOX-E36

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026