Table 4.
Tertiary prevention trials after diagnosis of diabetes: islet regeneration and β-cell rest
| Study (ref.) | Drug/phase | Sponsor/contact | Age (years) | Time from diagnosis/eligibility | Route | Dosing | Treated: placebo | Follow-up duration/primary end point | Status/target size |
|---|---|---|---|---|---|---|---|---|---|
| Islet regeneration (103) | Exenatide/phase IV | NIH, Baylor College of Medicine/Rubina Heptulla, MD | 12–21 | ≥1 year | s.c. | Each patient to receive 3 different doses | 1:1 | AUC glucose | Enrollment closed/n = 17 |
| SPIRIT1 (104) | INGAP peptide/phase II | Procter & Gamble/kathleen.dungan@osumc.edu | 18–65 | Age of diagnosis <20 years/fasting C-peptide ≤0.1 pmol/ml | s.c. | 300 or 600 mg/day for 90 days | 1:1 | 6 months/Arg-stimulated C-peptide | Enrollment closed/n = 63 |
| Islet regeneration and metabolic control (105) | Pioglitazone/phase I | Stony Brook University/thomas.a.wilson@sunysb.edu | 6–18 | ≤12 week | p.o. | 1:1? | 4 months/adverse events, MMTT C-peptide | Enrolling/n = ? | |
| TrialNet metabolic control (74) | Near normoglycemia/phase II | NIH, NIDDK, TrialNet/diabetestrialnet.org | 3–20 | 1–7 days | NA | Insulin pump therapy and CGM | Open label | 2 years/MMTT C-peptide | Not yet enrolling/n = 108 |
| β-Cell rest (106) | Diazoxide/phase IV | University of Trondheim, Norway/valdemar.grill@ntnu.no | 18–40 | ≤12 weeks/C-peptide* >0.2 pmol/ml | p.o. | Daily at bedtime for 6 months | 1:1 | At least 1 year/C-peptide, A1C | Enrollment 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.