NCT01513369

Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency

Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: GWT-TUD GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the correlation between HbA1c and iron status in Type 2 Diabetes mellitus patients with iron deficiency by intravenous substitution of iron.

Conditions

• Type 2 Diabetes Mellitus
• Iron Deficiency

Interventions

Type	Name	Description
DRUG	ferric carboxymaltose	Dose:according to SmPC Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
DRUG	NaCl (0,9%)	Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous

Timeline

• Start date: 2012-08-01
• Primary completion: 2018-10-01
• Completion: 2019-04-01
• First posted: 2012-01-20
• Last updated: 2021-02-04

Locations

6 sites across 1 country: Germany