Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01547897
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2012-02-27
Brief Title:
NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
Sponsor:
TME Pharma AG
Organization:
TME Pharma AG
Study Overview
Official Title:
A Phase IIa Study to Characterize the Effects of CCL2 Inhibition With the Spiegelmer NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective
- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio ACR in patients with type 2 diabetes and albuminuria
Secondary objectives
To characterize the effect of study drug on glycosylated hemoglobin fraction HbA1c
To evaluate the effect of study drug on markers of glycemic disorders systemic inflammation renal and liver disease and cardiovascular function
To assess the safety and tolerability of study drug
To determine the population pharmacokinetics PK of study drug
- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio ACR in patients with type 2 diabetes and albuminuria
Secondary objectives
To characterize the effect of study drug on glycosylated hemoglobin fraction HbA1c
To evaluate the effect of study drug on markers of glycemic disorders systemic inflammation renal and liver disease and cardiovascular function
To assess the safety and tolerability of study drug
To determine the population pharmacokinetics PK of study drug
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-005710-11 | EUDRACT_NUMBER | None | None |