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

This study has been completed.
Sponsor:
Collaborator:
Profil Institut für Stoffwechselforschung GmbH
Information provided by (Responsible Party):
NOXXON Pharma AG
ClinicalTrials.gov Identifier:
NCT01085292
First received: March 10, 2010
Last updated: February 12, 2013
Last verified: February 2013

March 10, 2010
February 12, 2013
July 2010
February 2012   (final data collection date for primary outcome measure)
Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability of multiple subcutaneous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus
Complete list of historical versions of study NCT01085292 on ClinicalTrials.gov Archive Site
Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: NOX-E36
    Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d
  • 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
  • Experimental: Group A
    Intervention: Drug: NOX-E36
  • Experimental: Group B - D
    Intervention: Drug: NOX-E36
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01085292
SNOXE36C101, 2010-019148-38
Yes
NOXXON Pharma AG
NOXXON Pharma AG
Profil Institut für Stoffwechselforschung GmbH
Study Director: Grit Landgraf, PhD Noxxon AG
NOXXON Pharma AG
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP