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Cited by 176Diabetes Treatment and ManagementDiabetes Management and ResearchPancreatic function and diabetes

Impact of insulin and metformin versus metformin alone on β-cell function in youth with impaired glucose tolerance or recently diagnosed type 2 diabetes

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The RISE Consortium, Nadeau, Kristen J., Hannon, Tamara S., Edelstein, Sharon L., Arslanian, Silva A., Caprio, Sonia, Leschek, Ellen W., Zeitler, Philip S. +52 more·2018·Diabetes Care
DOI 10.2337/dc18-0787PMC PMC6054504
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Abstract

OBJECTIVE: Pediatric type 2 diabetes prevalence is increasing, with β-cell dysfunction key in its pathogenesis. The RISE Pediatric Medication Study compared two approaches—glargine followed by metformin and metformin alone—in preserving or improving β-cell function in youth with impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes during and after therapy withdrawal. RESEARCH DESIGN AND METHODS: Ninety-one pubertal, overweight/obese 10–19-year-old youth with IGT (60%) or type 2 diabetes of <6 months duration (40%) were randomized to either 3 months of insulin glargine with a target glucose of 4.4–5.0 mmol/L followed by 9 months of metformin or to 12 months of metformin alone. β-Cell function (insulin sensitivity paired with β-cell responses) was assessed by hyperglycemic clamp at baseline, 12 months (on treatment), and 15 months (3 months off treatment). RESULTS: No significant differences were observed between treatment groups at baseline, 12 months, or 15 months in β-cell function, BMI percentile, HbA1c, fasting glucose, or oral glucose tolerance test 2-h glucose results. In both treatment groups, clamp-measured β-cell function was significantly lower at 12 and 15 months versus baseline. HbA1c fell transiently at 6 months within both groups. BMI was higher in the glargine followed by metformin versus metformin alone group between 3 and 9 months. Only 5% of participants discontinued the interventions, and both treatments were well tolerated. CONCLUSIONS: In youth with IGT or recently diagnosed type 2 diabetes, neither 3 months of glargine followed by 9 months of metformin nor 12 months of metformin alone halted the progressive deterioration of β-cell function. Alternate approaches to preserve β-cell function in youth are needed.

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  • Affected young people have a more rapid deterioration in blood glucose levels, an attenuated response to diabetes medication, and more rapid development of diabetes complications.

    “Affected young people have a more rapid deterioration in blood glucose levels, an attenuated response to diabetes medication, and more rapid development of diabetes complications (269 -273).”

    From Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022) · cites this paper as [269]

    The Abstract reports faster disease progression in youth than in adults, and the Conclusions describe a poor response to the RISE interventions and no durable benefit for glycemia or β-cell function. These passages support the progression and medication-response portions of the claim, but our copy does not report that diabetes complications develop more rapidly in young people (searched: complications). (LLM, conf=0.86)

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Research works printed but not linked: 2

  1. Hannon TS, Kahn SE, Utzschneider KM, et al.; The RISE Consortium. Review of methods for measuring b-cell function: Design considerations from the Restoring Insulin Secretion (RISE) Con- sortium. Diabetes Obes Metab 2018;20:14-24
  2. metformin was given from baseline through 12 months. Treatment was discontinued in both groups at 12 months. Data are mean 6 SEM. *P , 0.05 for the difference between treatment groups at the specified time point; §P , 0.05 for the difference within treatment group between the specified time point and baseline. insulin resistance. Diabetes Care 1996;19:278- 286

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Authors
The RISE Consortium, Nadeau, K. J., Hannon, T. S., Edelstein, S. L., Arslanian, S. A., Caprio, S., Leschek, E. W., Zeitler, P. S., Buchanan, T. A., Ehrmann, D. A., Mather, K. J., Kahn, S. E., Gross, S., Williams, J., Cree-Green, M., Reyes, Y. G., Vissat, K., Brown, K., Guerra, N., Porter, K., Savoye, M., Pierpont, B., Garrett, T., Lteif, A., Patel, A., Chisholm, R., Moore, K., Pirics, V., Pratt, L., Temple, K. A., Rue, A., Barengolts, E., Mokhlesi, B., Van Cauter, E., Sam, S., Miller, M. A., Atkinson, K. M., Palmer, J. P., Utzschneider, K. M., Gebremedhin, T., Kernan-Schloss, A., Kozedub, A., Montgomery, B. K., Morse, E. J., Xiang, A. H., Trigo, E., Beale, E., Hendee, F. N., Katkhouda, N., Nayak, K., Martinez, M., Montgomery, C., Wang, X., Lachin, J. M., Hogan, A. N., Marcovina, S., Harting, J., Albers, J., Hill, D., & Savage, P. J.
Affiliations
RISE Coordinating Center, Rockville, MD
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2018-06-25
Volume
41
Issue
8
Pages
1717-1725
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc18-0787
PMC
PMC6054504
OpenAlex
W2912120894
Cited by
176
References
24
Citations by year
2026: 14 · 2025: 24 · 2024: 22 · 2023: 23 · 2022: 22 · 2021: 25 · 2020: 20 · 2019: 17 · 2018: 9
FWCI
14.11
Type
journal article
Language
en
Open access
Licence
www.diabetesjournals.org/content/license (vor, 25 d)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institute of Diabetes and Digestive and Kidney Diseases (U01-DK-094406, U01-DK-094430, U01-DK-094431, U01-DK-094438, U01-DK-094467, P30-DK-017047, P30-DK-020595, P30-DK-045735, P30-DK-097512)
  • National Center for Advancing Translational Sciences (UL1-TR-000430, UL1-TR-001082, UL1-TR-001108, UL1-TR-001855, UL1-TR-001857, UL1-TR-001858, UL1-TR-001863)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Surgery › Pancreatic function and diabetes
Keywords
insulin glargine, metformin, beta-cell function, impaired glucose tolerance, pediatric type 2 diabetes, youth, hyperglycemic clamp, treatment withdrawal, insulin sensitivity, obesity, HbA1c, treatment tolerability
MeSH terms
Insulin Glargine, Adolescent, Age Factors, Blood Glucose, Child, Diabetes Mellitus, Type 2, Drug Therapy, Combination, Female, Glucose Tolerance Test, Humans, Insulin, Insulin Resistance, Male, Metformin, Glucose Intolerance, Insulin-Secreting Cells, Young Adult

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