Table 4

Tertiary prevention trials after diagnosis of diabetes: islet regeneration and β-cell rest

Study (ref.)Drug/phaseSponsor/contactAge (years)Time from diagnosis/eligibilityRouteDosingTreated: placeboFollow-up duration/primary end pointStatus/target size
Islet regeneration (103)Exenatide/phase IVNIH, Baylor College of Medicine/Rubina Heptulla, MD12–21≥1 years.c.Each patient to receive 3 different doses1:1AUC glucoseEnrollment closed/n = 17
SPIRIT1 (104)INGAP peptide/phase IIProcter & Gamble/kathleen.dungan@osumc.edu18–65Age of diagnosis <20 years/fasting C-peptide ≤0.1 pmol/mls.c.300 or 600 mg/day for 90 days1:16 months/Arg-stimulated C-peptideEnrollment closed/n = 63
Islet regeneration and metabolic control (105)Pioglitazone/phase IStony Brook University/thomas.a.wilson@sunysb.edu6–18≤12 weekp.o.1:1?4 months/adverse events, MMTT C-peptideEnrolling/n = ?
TrialNet metabolic control (74)Near normoglycemia/phase IINIH, NIDDK, TrialNet/diabetestrialnet.org3–201–7 daysNAInsulin pump therapy and CGMOpen label2 years/MMTT C-peptideNot yet enrolling/n = 108
β-Cell rest (106)Diazoxide/phase IVUniversity of Trondheim, Norway/valdemar.grill@ntnu.no18–40≤12 weeks/C-peptide* >0.2 pmol/mlp.o.Daily at bedtime for 6 months1:1At least 1 year/C-peptide, A1CEnrollment closed/n = 35
  • *Stimulated. AUC, area under the curve; CGM, continuous glucose monitoring; INGAP, islet neogenesis-associated protein; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NIH, National Institutes of Health; SPIRIT1, Stimulation of Pancreatic Islet Regeneration In Type 1 and Type 2 diabetes.