The use of intermediate endpoints in the design of type 1 diabetes prevention trials

Diabetologia

Volumn 56, Issue 9, 2013, Pages 1919-1924

  Krischer, Jeffrey P ^a  

^a UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

C peptide; Clinical trial; Dysglycaemia; HbA1c; Intermediate endpoints; Prevention; Type 1 diabetes

Indexed keywords

AUTOANTIBODY; C PEPTIDE; HEMOGLOBIN A1C;

ADOLESCENT; ADULT; ARTICLE; CHILD; DISEASE ASSOCIATION; DISEASE COURSE; DISEASE MARKER; FEMALE; HEMOGLOBIN BLOOD LEVEL; HIGH RISK PATIENT; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; MAJOR CLINICAL STUDY; MALE; ORAL GLUCOSE TOLERANCE TEST; OUTCOME ASSESSMENT; PRESCHOOL CHILD; PREVENTION STUDY; PRIORITY JOURNAL; PROTEIN DEPLETION; RISK ASSESSMENT; SCHOOL CHILD; STUDY DESIGN;

ADOLESCENT; ADULT; AUTOANTIBODIES; BLOOD GLUCOSE; C-PEPTIDE; CHILD; CHILD, PRESCHOOL; DIABETES MELLITUS, TYPE 1; FEMALE; GLUCOSE TOLERANCE TEST; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; INFANT; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 84881614660     PISSN: 0012186X     EISSN: 14320428     Source Type: Journal    
DOI: 10.1007/s00125-013-2960-7     Document Type: Article

References (10)

1. Atkinson MA, Eisenbarth GS (2001) Type 1 diabetes: new perspectives on disease pathogenesis and treatment. Lancet 358:221-229
2. American Diabetes Association (2011) Diagnosis and classification of diabetes mellitus. Diabetes Care 34:62-69
3. Sosenko JM, Palmer JP, Greenbaum CJ et al (2006) Patterns of metabolic progression to type 1 diabetes in the Diabetes Prevention Trial-Type 1. Diabetes Care 29:643-649
4. Sosenko JM, Palmer JP, Rafkin-Mervis L et al (2008) Glucose and C-peptide changes in the perionset period of type 1 diabetes in the Diabetes Prevention Trial-Type 1. Diabetes Care 31:2188-2192
5. TRIGR Investigators (2007) Study design of the trial to reduce IDDM in the genetically at risk (TRIGR). Pediatr Diabetes 8:117-137
6. Skyler JS, Krischer JP, Wolfsdorf J et al (2005) Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial-Type 1. Diabetes Care 28:1068-1076
7. Mahon JL, Sosenko JM, Rafkin-Mervis L et al (2009) The TrialNet natural history study of the development of type 1 diabetes: objectives, design, and initial results. Pediatr Diabetes 10:97-104
8. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Amer Statist Assn 53:457-481
9. Greenwood M (1926) The natural duration of cancer. Reports on public health and medical subjects, vol. 33. Her Majesty's Stationery Office, London, pp 1-26
10. Fleming TR (2005) Surrogate endpoints and FDA's accelerated approval process. Health Aff (Millwood) 24:67-78