DIATOR-Diabetes Intervention With Atorvastatin

Summary

Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated C-peptide levels.

Timeline

Start

2004-03

Primary completion

2008-01

Completion

2009-03

Outcome

Missed primary endpoint

Stopped (Enrollment): “for lack of recruitment”

paper Atorvastatin treatment did not significantly preserve beta cell function although there may have been a slower decline of beta-cell function which merits further study. PMID 21412424 ↗

Publications

• Kolb H, Luckemeyer K, Heise T, Herder C, Schloot NC, Koenig W, Heinemann L, Martin S; DIATOR Study Group. The systemic immune network in recent onset type 1 diabetes: central role of interleukin-1 receptor antagonist (DIATOR Trial). PLoS One. 2013 Aug 26;8(8):e72440. doi: 10.1371/journal.pone.0072440. eCollection 2013.
• Strom A, Kolb H, Martin S, Herder C, Simon MC, Koenig W, Heise T, Heinemann L, Roden M, Schloot NC; DIATOR Study Group. Improved preservation of residual beta cell function by atorvastatin in patients with recent onset type 1 diabetes and high CRP levels (DIATOR trial). PLoS One. 2012;7(3):e33108. doi: 10.1371/journal.pone.0033108. Epub 2012 Mar 20.
• Martin S, Herder C, Schloot NC, Koenig W, Heise T, Heinemann L, Kolb H; DIATOR Study Group. Residual beta cell function in newly diagnosed type 1 diabetes after treatment with atorvastatin: the Randomized DIATOR Trial. PLoS One. 2011 Mar 11;6(3):e17554. doi: 10.1371/journal.pone.0017554.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	80 mg	Oral

Indications