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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085292
• Other study ID #: SNOXE36C101
• Secondary ID: 2010-019148-38
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 10, 2010
• Last updated: February 12, 2013
• Start date: July 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2013
• Source: NOXXON Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• NOX-E36
Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d
• 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

Locations

Country	Name	City	State
Germany	CTC North MediGate GmbH	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Itecra GmbH	Köln
Germany	ikfe GmbH	Mainz
Germany	Profil Institut fuer Stoffwechselforschung GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
NOXXON Pharma AG	Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus		4 weeks	Yes
Secondary	Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus		4 weeks	No