NCT00751842

A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (USA)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Diamyd Therapeutics AB · Industry
• Sex: All
• Age: 10 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes. Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	rhGAD65	Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.
DRUG	rhGAD65	Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.
DRUG	Placebo	Placebo injected subcutaneously at days 1, 30, 90 and 270.

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2008-09-12
• Last updated: 2012-10-10

Locations

43 sites across 1 country: United States