Originally published May 1, 2018 by
These papers published in the December 2017 issue of Diabetes Care summarize the recent progress in continuous glucose monitoring (CGM) measurements and interpretation, describe the properties and limitations of available CGM systems, propose minimum standards for these systems, address practical issues related to daily use and discuss proposed measures of glycemic control other than A1C, including categories of hypoglycemia and proportions of time in glucose target ranges during CGM.
Reading the editorial first and then the position statements in any order followed by reading the editorial again would be a reasonable strategy to tackle these valuable but complex issues.
Maturation of CGM and Glycemic Measurements Beyond HbA1c—A Turning Point in Research and Clinical Decisions. Matthew C. Riddle, Hertzel C. Gerstein and William T. Cefalu. Diabetes Care, 2017 Dec; 40 (12): 1611-1613. https://doi.org/10.2337/dci17-0049
I. Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations. A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. John R. Petrie, Anne L. Peters, Richard M. Bergenstal, Reinhard W. Holl, G. Alexander Fleming and Lutz Heinemann. Diabetes Care, 2017 Dec;40(12):1614-1621. https://doi.org/10.2337/dci17-0043
II. Standardizing Clinically Meaningful Outcome Measures beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. Gina Agiostratidou, Henry Anhalt, Dana Ball, Lawrence Blonde, Evgenia Gourgari, Karen N. Harriman, Aaron J. Kowalski, Paul Madden, Alicia H. McAuliffe-Fogarty, Molly McElwee-Malloy, Anne Peters, Sripriya Raman, Kent Reifschneider, Karen Rubin and Stuart A. Weinzimer. Diabetes Care, 2017 Dec;40(12):1622-1630. https://doi.org/10.2337/dc17-1624
III. International Consensus on Use of Continuous Glucose Monitoring. Thomas Danne, Revital Nimri, Tadej Battelino, Richard M. Bergenstal, Kelly L. Close, J. Hans DeVries, Satish Garg, Lutz Heinemann, Irl Hirsch, Stephanie A. Amiel, Roy Beck, Emanuele Bosi, Bruce Buckingham, Claudio Cobelli, Eyal Dassau, Francis J. Doyle III, Simon Heller, Roman Hovorka, Weiping Jia, Tim Jones, Olga Kordonouri, Boris Kovatchev, Aaron Kowalski, Lori Laffel, David Maahs, Helen R. Murphy, Kirsten Nørgaard, Christopher G. Parkin, Eric Renard, Banshi Saboo, Mauro Scharf, William V. Tamborlane, Stuart A. Weinzimer and Moshe Phillip. Diabetes Care, 2017 Dec;40(12):1631-1640. https://doi.org/10.2337/dc17-1600
Study Title Acronym: SUSTAIN 7
ClinicalTrials.gov Identifier: NCT02648204
Sponsor: Novo Nordisk A/S
Study Design: Randomized, parallel assignment, open label, enrolling 1201 participants
Intervention: Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once a week treatment with either semaglutide 0.5 mg, dulaglutide 0.75 mg, semaglutide 1.0 mg, or dulaglutide 1.5 mg subcutaneously.
Primary Outcome Measure: Change in A1C at week 40
Secondary Outcome Measures:
Results: 1201 patients were randomized, with 94% completing the trial. The mean A1C change was compared between the low doses and high doses.
Mean bodyweight change was compared between the low doses and the high doses.
Summary: This study demonstrates that when directly comparing low and high doses of semaglutide to dulaglutide, the improvements in A1C and body weight are statistically significantly better with semaglutide, with similar safety profiles.
Semaglutide is the newest GLP-1 to become available to the U.S. market. These data suggest that we may be able to get patients with A1Cs of 8.5-8.8% to goal by adding semaglutide with a concomitant weight loss of at least 10 lbs.
Study Title Acronym: SUSTAIN 3
ClinicalTrials.gov Identifier: NCT01885208
Sponsor: Novo Nordisk A/S
Study Design: Randomized, parallel assignment, open label
Intervention: 1.0 mg semaglutide or 2.0 mg exenatide ER once weekly
Primary Outcome Measure: Change from baseline in A1C at week 56
Secondary Outcome Measures:
Results: In all, 813 participants were randomized to 56 weekly treatments of semaglutide or exenatide ER.
Mean baseline A1C of 8.3% was reduced by 1.5% with semaglutide and 0.9% with exenatide ER. The estimated treatment difference for semaglutide versus exenatide ER was -0.62% [95% CI -0.80, -0.44] P < 0.0001 for noninferiority and superiority). In all, 67% of the subjects treated with semaglutide achieved A1C <7.0% versus 40% of those taking exenatide ER.
Mean body weight of 95.8 kg at baseline was reduced by 5.6 kg with semaglutide and 1.9 kg with exenatide ER for an estimated treatment difference of -3.78 kg [95% CI -4.58, -2.98]; P < 0.0001).
Summary: This study compared semaglutide directly with the once-weekly formulation of exenatide. It found that semaglutide at a dose of 1.0 mg weekly was superior to the current weekly exenatide ER dose (2.0 mg/week) at improving glycemic control and reducing body weight after 56 weeks of treatment. Safety profiles were similar between the two drugs.
This study provides more evidence of the efficacy of the newest GLP-1 and allows us to compare it to exenatide, which has been available in the U.S. since 2012. The 1.5% decrease in A1C shows that we could anticipate getting A1C to goal by adding semaglutide if a patient has an A1C of 8.5% or less on his or her current regimen.
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About our expert: Kathleen Wyne, MD, PhD, FACE, FNLA, Associate Professor, Division of Endocrinology, Diabetes and Metabolism, The Ohio State University, Wexner Medical Center, Columbus
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