Table 2

Reversal trials in type 1 diabetes

Study nameTreatment(s)C-peptide at 1 year (nmol/L)Preservation of C-peptideReference
Cyclosporin Treatment in Children with Recent-Onset Type 1 Diabetes°Cyclosporin A0.3Yes*72
Continuous Insulin Infusion Throughout the First Two Weeks Following Type 1 Diabetes Onset°Intensive insulin therapy0.5Yes73
IMDIAB IVVitamin E0.2Yes74
IMDIAB VINicotinamide0.2Yes75
Diabète Insuline OraleOral insulin0.1No76
Diazoxide Treatment in Children with New-Onset Type 1 Diabetes°Diazoxide0.2Yes79
The Use of Polyclonal Anti–T-Lymphocyte Globulin to Prevent Progression of Autoimmune β-Cell Destruction in Recent Type 1 DiabetesATG0.2Yes80
IMDIAB IXNicotinamide + vitamin E0.2Yes**81
IMDIAB (retrospective analysis)Nicotinamide + intensive insulin therapy0.1Yes**82
TTEDDChAglyCD3 (otelixizumab)0.5Yes83
Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 DiabeteshOKT3gamma1(Ala-Ala)0.2Yes84
IMDIAB XICalcitriol + nicotinamide0.1No85
Autologous Hematopoietic Stem Cell Transplantation in Type 1 Diabetes MellitusAHSCT0.3Yes87
Phase II Trial of DiaPep277 in Children with New-Onset Type 1 Diabetes°DiaPep2770.2No88
DIA-AID2DiaPep2770.4Yes (trend)#89
A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes MellitusGAD-alum0.1No90
Phase II Multiple Dose Treatment of Type 1 Diabetes Mellitus With hOKT3gamma1(Ala-Ala)Teplizumab0.8Yes (trend)91
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel, Dose-Ranging Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of NBI-6024 In Adult and Adolescent Patients With New Onset Type 1 Diabetes MellitusNBI-60240.1No92
Autologous Hematopoietic Stem Cell Transplantation in Type 1 Diabetes MellitusAHSCTAUC = 30Yes53
Effects of Rituximab on the Progression of Type 1 Diabetes in New Onset SubjectsRituximab0.1Yes¥93
ENBREL (Etanercept) Administration to Patients Newly Diagnosed With Type 1 Diabetes Mellitus: Feasibility-Safety StudyEtanercept0.4Yes94
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic PatientsChAgly CD3AUC = 0.9Yes#95
Efficacy of 6 Months Treatment With Diazoxide at Bedtime in Preventing β-Cell Demise in Newly Diagnosed Type 1 DiabetesDiazoxide0.1No96
Immunointervention With 1,25-dihydroxy-vitamin D3 in New-Onset Type 1 Diabetes1,25(OH)2D30.1No97
Protégé studyTeplizumab0.5Yes#98
TrialNet GADGAD-alum0.3No99
TrialNet AbataceptAbatacept0.3No100
Efficacy of ATG + Autologous CD34+ Stem Cells + GCSF in New-Onset Type 1 Diabetes°Mobilized hematopoietic CD34+ stem cells0.4Yes102
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 (EU)GAD-alum0.3No103
Prospective Study of Autologous Hematopoietic Stem Cell Transplantation to Treat New Onset Type 1 DiabetesAHSCT0.6Yes105
Safety and Efficacy Study of Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation for Early Onset Type 1 Diabetes—A Phase II StudyAHSCTYes106
A Phase I Trial of Proleukin and Rapamune in Recent-Onset Type 1 Diabetes Mellitus (ITN018AI)Rapamycin/interleukin (IL)-2AUC = 6.3No107
Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes (anti–IL-1)/ Anti–Interleukin-1 in Diabetes ActionCanakinumab/Anakinra0.1No108
Reversing Type 1 Diabetes After it is Established: A Pilot Safety and Feasibility Study of Anti-Thymocyte Globulin (Thymoglobulin) and Pegylated GCSF (Neulasta) in Established Type 1 DiabetesATG + GCSF0.74Yes54
  • Adapted with permission from Ben Nasr et al. (10). AbATE, Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes; AHSCT, autologous hematopoietic stem cell transplantation; ATG, anti–T-lymphocyte globulin; AUC, area under the curve; DIA-AID, Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults; DIATOR, Diabetes Intervention With Atorvastatin; GCSF, granulocyte-colony stimulating factor; IMDIAB, IMmunotherapy of DIABetes; TTED, TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM).

  • ◆Defined as author-reported interpretation.

  • °Official study name could not be determined.

  • *Effect lost on withdrawal of treatment.

  • **No synergistic benefit with combination.

  • §Differential outcomes depending on dose.

  • #Differential effects depending on age-group.

  • ¥Reported partial preservation of β-cell function.

  • †Differential effects depending on baseline C-reactive protein concentrations.