C-Peptide Is the Appropriate Outcome Measure for Type 1 Diabetes Clinical Trials to Preserve β-Cell Function

Palmer, Jerry P.; Fleming, G. Alexander; Greenbaum, Carla J.; Herold, Kevan C.; Jansa, Lisa D.; Kolb, Hubert; Lachin, John M.; Polonsky, Kenneth S.; Pozzilli, Paolo; Skyler, Jay S.; Steffes, Michael W.

doi:10.2337/diabetes.53.1.250

Cited by 491Diabetes and associated disordersDiabetes Management and ResearchPancreatic function and diabetes

C-Peptide Is the Appropriate Outcome Measure for Type 1 Diabetes Clinical Trials to Preserve β-Cell Function

Palmer, Jerry P., Fleming, G. Alexander, Greenbaum, Carla J., Herold, Kevan C., Jansa, Lisa D., Kolb, Hubert, Lachin, John M., Polonsky, Kenneth S. +3 more·2004·Diabetes

DOI 10.2337/diabetes.53.1.250

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Abstract

The underlying cause of type 1 diabetes, loss of β-cell function, has become the therapeutic target for a number of interventions in patients with type 1 diabetes. Even though insulin therapies continue to improve, it remains difficult to achieve normal glycemic control in type 1 diabetes, especially long term. The associated risks of hypoglycemia and end-organ diabetic complications remain. Retention of β-cell function in patients with type 1 diabetes is known to result in improved glycemic control and reduced hypoglycemia, retinopathy, and nephropathy. To facilitate the development of therapies aimed at altering the type 1 diabetes disease process, an American Diabetes Association workshop was convened to identify appropriate efficacy outcome measures in type 1 diabetes clinical trials. The following consensus emerged: While measurements of immune responses to islet cells are important in elucidating pathogenesis, none of these measures have directly correlated with the decline in endogenous insulin secretion. HbA1c is a highly valuable clinical measure of glycemic control, but it is an insensitive measure of β-cell function, particularly with the currently accepted standard of near-normal glycemic control. Rates of severe hypoglycemia and diabetic complications ultimately will be improved by therapies that are effective at preserving β-cell function but as primary outcomes require inordinately large and protracted trials. Endogenous insulin secretion is assessed best by measurement of C-peptide, which is cosecreted with insulin in a one-to-one molar ratio but unlike insulin experiences little first pass clearance by the liver. Measurement of C-peptide under standardized conditions provides a sensitive, well accepted, and clinically validated assessment of β-cell function. C-peptide measurement is the most suitable primary outcome for clinical trials of therapies aimed at preserving or improving endogenous insulin secretion in type 1 diabetes patients. Available data demonstrate that even relatively modest treatment effects on C-peptide will result in clinically meaningful benefits. The development of therapies for addressing this important unmet clinical need will be facilitated by trials that are carefully designed with β-cell function as determined by C-peptide measurement as the primary efficacy outcome.

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In adults screened for DCCT who were more than 5 years post diagnosis, 8% had a stimulated serum C-peptide above 200 pmol/L.
“This is similar to the 8% of adults over 5 years post diagnosis who had a stimulated serum C-peptide >200 pmol/L when screened for DCCT(20).”
From Most people with long-duration type 1 diabetes in a large population-based study are insulin microsecretors (2015) · cites this paper as [20]

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Insulin and Glucagon Secretion in Patients with Slowly Progressing Autoimmune Diabetes (LADA)
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Autoantibody Recognition of COOH-Terminal Epitopes of GAD65 Marks the Risk for Insulin Requirement in Adult-Onset Diabetes Mellitus
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Plasma C-Peptide Levels and Clinical Remissions in Recent-Onset Type I Diabetic Patients Treated With Cyclosporin A and Insulin
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Evidence of an accelerated B-cell destruction in HLA-Dw3/Dw4 heterozygous children with Type 1 (insulin-dependent) diabetes
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Ingestion of a Mixed Meal Does Not Affect the Metabolic Clearance Rate of Biosynthetic Human C-Peptide*
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Loss of insulin response to glucose but not arginine during the development of autoimmune diabetes in BB/W rats: relationships to islet volume and glucose transport rate.
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Exposure to exogenous insulin promotes IgG1 and the T-helper 2-associated IgG4 responses to insulin but not to other islet autoantigens.
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Correlation between minimal secretory capacity of pancreatic beta-cells and stability of diabetic control
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Residual β-Cell Function and HLA-A24 in IDDM: Markers of Glycemic Control and Subsequent Development of Diabetic Retinopathy
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Comparison of GAD and ICA512/IA-2 Antibodies at and After the Onset of IDDM
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Clinical Evaluation of Non-Insulin-Dependent Diabetes Mellitus Patients with Autoantibodies to Glutamic Acid Decarboxylase
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Maleness as Risk Factor for Slowly Progressive IDDM
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High-Dose Intravenous Insulin Infusion Versus Intensive Insulin Treatment in Newly Diagnosed IDDM
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Residual C-peptide excretion is associated with a better long-term glycemic control and slower progress of retinopathy in type I (insulin-dependent) diabetes mellitus
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Report From the 1st International NOD Mouse T-Cell Workshop and the Follow-Up Mini-Workshop
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Plasma C-peptide levels and clinical remissions in recent-onset type I diabetic patients treated with cyclosporin A and insulin
Assan, R., Feutren, G., Sirmai, J., et al. (1990) · Diabetes · doi:10.2337/diabetes.39.7.768 · Cited by 22 · see citing works
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Untitled work
Randle (1998) · doi:10.1002/(sici)1099-0895(199812)14:4
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Gold (1997) · doi:10.1002/(sici)1096-9136(199702)14:2
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(2000) · doi:10.1002/1520-7560(2000)9999:9999

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Rituximab, B-lymphocyte depletion, and preservation of beta-cell function
Pescovitz, M. D., Greenbaum, C. J., Krause-Steinrauf, H., Becker, D. J., Gitelman, S. E., Goland, R., Gottlieb, P. A., Marks, J. B., McGee, P. F., Moran, A. M., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0904452 · Cited by 1,093 · see citing works
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A practical review of C-peptide testing in diabetes
Leighton, E., Sainsbury, C. A., & Jones, G. C. (2017) · Diabetes Therapy · doi:10.1007/s13300-017-0265-4 · Cited by 773 · see citing works
Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled trial
Orban, T., Bundy, B., Becker, D. J., DiMeglio, L. A., Gitelman, S. E., Goland, R., Gottlieb, P. A., Greenbaum, C. J., Marks, J. B., Monzavi, R., et al. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60886-6 · Cited by 612 · see citing works
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Implementing a reference measurement system for C-peptide: successes and lessons learned
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Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial
Wherrett, D. K., Bundy, B., Becker, D. J., DiMeglio, L. A., Gitelman, S. E., Goland, R., Gottlieb, P. A., Greenbaum, C. J., Herold, K. C., Marks, J. B., et al. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60895-7 · Cited by 371 · see citing works
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Effects of interrupting prolonged sitting with physical activity breaks on blood glucose, insulin and triacylglycerol measures: A systematic review and meta-analysis
Loh, R., Stamatakis, E., Folkerts, D., Allgrove, J. E., & Moir, H. J. (2020) · Sports Medicine · doi:10.1007/s40279-019-01183-w · Cited by 326 · see citing works
The majority of patients with long-duration type 1 diabetes are insulin microsecretors and have functioning beta cells
Oram, R. A., Jones, A. G., Besser, R. E. J., Knight, B. A., Shields, B. M., Brown, R. J., Hattersley, A. T., & McDonald, T. J. (2014) · Diabetologia · doi:10.1007/s00125-013-3067-x · Cited by 298 · see citing works
Impact of C-peptide preservation on metabolic and clinical outcomes in the Diabetes Control and Complications Trial
Lachin, J. M., McGee, P., Palmer, J. P., & for the DCCT/EDIC Research Group (2014) · Diabetes · doi:10.2337/db13-0881 · Cited by 283 · see citing works
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Prevalence of detectable C-peptide according to age at diagnosis and duration of type 1 diabetes
Davis, A. K., DuBose, S. N., Haller, M. J., Miller, K. M., DiMeglio, L. A., Bethin, K. E., Goland, R. S., Greenberg, E. M., Liljenquist, D. R., Ahmann, A. J., et al. (2015) · Diabetes Care · doi:10.2337/dc14-1952 · Cited by 261 · see citing works
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Treatment of patients with new onset type 1 diabetes with a single course of anti-CD3 mAb teplizumab preserves insulin production for up to 5 years
Herold, K. C., Gitelman, S., Greenbaum, C., Puck, J., Hagopian, W., Gottlieb, P., Sayre, P., Bianchine, P., Wong, E., Seyfert-Margolis, V., et al. (2009) · Clinical Immunology · doi:10.1016/j.clim.2009.04.007 · Cited by 219 · see citing works
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Estimating the Cost of Type 1 Diabetes in the U.S.: A Propensity Score Matching Method
Tao, B., Pietropaolo, M., Atkinson, M., Schatz, D., & Taylor, D. (2010) · PLoS ONE · doi:10.1371/journal.pone.0011501 · Cited by 197 · see citing works
Most people with long-duration type 1 diabetes in a large population-based study are insulin microsecretors
Oram, R. A., McDonald, T. J., Shields, B. M., Hudson, M. M., Shepherd, M. H., Hammersley, S., Pearson, E. R., Hattersley, A. T., & on behalf of the UNITED Team (2015) · Diabetes Care · doi:10.2337/dc14-0871 · Cited by 133 · see citing works
Age-dependent decline of β-cell function in type 1 diabetes after diagnosis: a multi-centre longitudinal study
Barker, A., Lauria, A., Schloot, N., Hosszufalusi, N., Ludvigsson, J., Mathieu, C., Mauricio, D., Nordwall, M., Van der Schueren, B., Mandrup‐Poulsen, T., et al. (2014) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.12216 · Cited by 101 · see citing works
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Lessons From the Mixed-Meal Tolerance Test
Besser, R. E. J., Shields, B. M., Casas, R., Hattersley, A. T., & Ludvigsson, J. (2013) · Diabetes Care · doi:10.2337/dc12-0836 · Cited by 91 · see citing works
Preservation of β-cell function in autoantibody-positive youth with diabetes
Greenbaum, C. J., Anderson, A. M., Dolan, L. M., Mayer-Davis, E. J., Dabelea, D., Imperatore, G., Marcovina, S., Pihoker, C., & for the SEARCH Study Group (2009) · Diabetes Care · doi:10.2337/dc08-2326 · Cited by 90 · see citing works
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Practical classification guidelines for diabetes in patients treated with insulin: a cross-sectional study of the accuracy of diabetes diagnosis
Hope, S. V., Wienand-Barnett, S., Shepherd, M., King, S. M., Fox, C., Khunti, K., Oram, R. A., Knight, B. A., Hattersley, A. T., Jones, A. G., et al. (2016) · British Journal of General Practice · doi:10.3399/bjgp16x684961 · Cited by 87 · see citing works
Urine C-peptide creatinine ratio is a noninvasive alternative to the mixed-meal tolerance test in children and adults with type 1 diabetes
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Clinical evolution of beta cell function in youth with diabetes: the SEARCH for Diabetes in Youth study
Dabelea, D., Mayer-Davis, E. J., Andrews, J. S., Dolan, L. M., Pihoker, C., Hamman, R. F., Greenbaum, C., Marcovina, S., Fujimoto, W., Linder, B., et al. (2012) · Diabetologia · doi:10.1007/s00125-012-2719-6 · Cited by 76 · see citing works
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Osteocalcin effect on human β-cells mass and function
Sabek, O. M., Nishimoto, S. K., Fraga, D., Tejpal, N., Ricordi, C., & Gaber, A. O. (2015) · Endocrinology · doi:10.1210/en.2015-1143 · Cited by 74 · see citing works
Randomized 52-week phase 2 trial of albiglutide versus placebo in adult patients with newly diagnosed type 1 diabetes
Pozzilli, P., Bosi, E., Cirkel, D., Harris, J., Leech, N., Tinahones, F. J., Vantyghem, M.-C., Vlasakakis, G., Ziegler, A.-G., & Janmohamed, S. (2020) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgaa149 · Cited by 45 · see citing works
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Liraglutide enhances insulin secretion and prolongs the remission period in adults with newly diagnosed type 1 diabetes (the <scp>NewLira</scp> study): A randomized, double‐blind, placebo‐controlled trial
Dejgaard, T. F., Frandsen, C. S., Kielgast, U., Størling, J., Overgaard, A. J., Svane, M. S., Olsen, M. H., Thorsteinsson, B., Andersen, H. U., Krarup, T., et al. (2024) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.15889 · Cited by 29 · see citing works
Diagnostic criteria for acute-onset type 1 diabetes mellitus (2012): Report of the Committee of Japan Diabetes Society on the Research of Fulminant and Acute-onset Type 1 Diabetes Mellitus
Kawasaki, E., Maruyama, T., Imagawa, A., Awata, T., Ikegami, H., Uchigata, Y., Osawa, H., Kawabata, Y., Kobayashi, T., Shimada, A., et al. (2013) · Diabetology International · doi:10.1007/s13340-013-0122-2 · Cited by 19 · see citing works
A Golden Hour and Golden Opportunity for β-Cell Preservation
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A Randomized Controlled Trial of an Internet-Based Mentoring Program for Type 1 Diabetes Patients with Inadequate Glycemic Control
Suh, S., Park, S., Cho, Y., Joung, J. Y., Jin, S., Kim, S., Kim, H. J., Bae, J. C., Chung, J. H., Min, Y. S., et al. (2012) · 15th International & 14th European Congress of Endocrinology
A Randomized Controlled Trial of an Internet-Based Mentoring Program for Type 1 Diabetes Patients with Inadequate Glycemic Control
Suh, S., Jean, C., Koo, M., Lee, S., Cho, M. J., Sim, K. H., Jin, S., Bae, J. C., & Kim, J. H. (2014) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2014.38.2.134 · Cited by 26 · see citing works
Endothelial Progenitor Cells Are Related to Glycemic Control in Children With Type 1 Diabetes Over Time
Hörtenhuber, T., Rami-Merhar, B. M., Satler, M., Nagl, K., Höbaus, C., Höllerl, F., Koppensteiner, R., Schernthaner, G., Schober, E., & Schernthaner, G.-H. (2013) · Diabetes Care · doi:10.2337/dc12-1206 · Cited by 55 · see citing works
Real-World Glycemic Outcomes with Early Omnipod 5 Use in Youth with Type 1 Diabetes
Marks, B. E., Meighan, S. S., Zehra, A., Douvas, J. L., Rearson, A., Suresh, R., Brown, E. A., & Wolf, R. M. (2023) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2023.0337 · Cited by 39 · see citing works
Hypoglycemic episodes are associated with inflammatory status in patients with type 1 diabetes mellitus
Kieć‐Wilk, B., Matejko, B., Raźny, U., Stankiewicz, M. A., SKUPIEN, J. K., Klupa, T., & Malecki, M. T. (2016) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2016.05.002 · Cited by 22 · see citing works

Authors: Palmer, J. P., Fleming, G. A., Greenbaum, C. J., Herold, K. C., Jansa, L. D., Kolb, H., Lachin, J. M., Polonsky, K. S., Pozzilli, P., Skyler, J. S., & Steffes, M. W.
Affiliations: University of Washington (US)
West Virginia Department of Agriculture (US)
Benaroya Research Institute (US)
Columbia University (US)
Heinrich Heine University Düsseldorf (DE)
George Washington University (US)
Washington University in St. Louis (US)
Università Campus Bio-Medico (IT)
University of Miami (US)
University of Minnesota (US)
ORCID: Fleming, G. Alexander
Greenbaum, Carla J.
Herold, Kevan C.
Kolb, Hubert
Lachin, John M.
Pozzilli, Paolo
Skyler, Jay S.
Venue: Diabetes
Publisher: American Diabetes Association
Published: 2004-01-01
Volume: 53
Issue: 1
Pages: 250-264
ISSN: 0012-1797 (ISSN-L)
1939-327X
DOI: 10.2337/diabetes.53.1.250
OpenAlex: W2184500611
Cited by: 491
References: 133
Citations by year: 2026: 24 · 2025: 20 · 2024: 19 · 2023: 21 · 2022: 22 · 2021: 19 · 2020: 16 · 2019: 21 · 2018: 17 · 2017: 16 · 2016: 30 · 2015: 26 · 2014: 28 · 2013: 36 · 2012: 24
FWCI: 9.89
Type: journal article
Language: en
Update notices: correction (2004-07-01)
Open access: closed
Locations: Diabetes (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Surgery › Pancreatic function and diabetes
Keywords: type 1 diabetes, C-peptide, beta-cell function, endogenous insulin secretion, clinical trial outcome measures, HbA1c, glycemic control, hypoglycemia, diabetes complications, islet autoimmunity
MeSH terms: C-Peptide, Diabetes Mellitus, Type 1, Humans, Islets of Langerhans, Predictive Value of Tests, Prognosis, Reproducibility of Results, Treatment Outcome

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C-Peptide Is the Appropriate Outcome Measure for Type 1 Diabetes Clinical Trials to Preserve β-Cell Function

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