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Impact of Insulin and Metformin Versus Metformin Alone on Β-Cell

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Impact of Insulin and Metformin Versus Metformin Alone on Β-Cell Diabetes Care Volume 41, August 2018 1717 Impact of Insulin and Metformin The RISE Consortium* Versus Metformin Alone on b-Cell Function in Youth With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes Diabetes Care 2018;41:1717–1725 | https://doi.org/10.2337/dc18-0787 OBJECTIVE Pediatric type 2 diabetes prevalence is increasing, with b-cell dysfunction key in its pathogenesis. The RISE Pediatric Medication Study compared two approachesd glargine followed by metformin and metformin alonedin preserving or improving b-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%) PATHOPHYSIOLOGY/COMPLICATIONS 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. b-Cell function (insulin sensitivity paired with b-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, RISE Coordinating Center, Rockville, MD 12 months, or 15 months in b-cell function, BMI percentile, HbA1c, fasting glucose, Corresponding author: Sharon L. Edelstein, rise@ or oral glucose tolerance test 2-h glucose results. In both treatment groups, clamp- bsc.gwu.edu. measured b-cell function was significantly lower at 12 and 15 months versus Received 10 April 2018 and accepted 13 May 2018. baseline. HbA1c fell transiently at 6 months within both groups. BMI was higher in the glargine followed by metformin versus metformin alone group between Clinical trial reg. no. NCT01779375, clinicaltrials 3 and 9 months. Only 5% of participants discontinued the interventions, and .gov. both treatments were well tolerated. This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/ CONCLUSIONS doi:10.2337/dc18-0787/-/DC1. *A complete list of the RISE Consortium Inves- In youth with IGT or recently diagnosed type 2 diabetes, neither 3 months of glargine tigators can be found in the Supplementary Data followed by 9 months of metformin nor 12 months of metformin alone halted online. the progressive deterioration of b-cell function. Alternate approaches to preserve © 2018 by the American Diabetes Association. b-cell function in youth are needed. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More infor- The SEARCH for Diabetes in Youth (SEARCH) epidemiological study has highlighted a mation is available at http://www.diabetesjournals continued increase in the incidence of type 2 diabetes in adolescents aged 10–19 .org/content/license. years, particularly among ethnic minority groups. The Treatment Options for See accompanying articles, pp. 1560, Type 2 Diabetes in Adolescents and Youth (TODAY) study demonstrated that in 1696, and 1707. 1718 b-Cell Function in Youth With Dysglycemia Diabetes Care Volume 41, August 2018 50% of youth with type 2 diabetes, Participants was withdrawn, and follow-up continued initial assigned treatment failed, re- A summary of study visits is shown in while off study medication for an additional quiring the initiation of insulin ther- Supplementary Fig. 1, and a summary of 3 months to determine the 15-month apy after an average follow-up of 3.9 participants enrolled and their rates of primary outcome of treatment durability. years, which is in keeping with faster dis- completion of study visits is shown in a Anthropometrics, HbA1c,andsafetyeval- ease progression than reported in adults CONSORT (Consolidated Standards of Re- uations were performed every 3 months, (1–3). In TODAY, lower b-cell function porting Trials) diagram (Supplementary and hyperglycemic clamps and OGTTs atbaselineaswellasagreaterdeclinein Fig. 2). Enrollment occurred between were repeated at 12 and 15 months b-cell function over time predicted worse July 2013 and April 2016. Youth aged (8–10) (Supplementary Fig. 1). Labora- glycemic control and treatment failure 10–19 years with a BMI $85th percen- tory assessments were performed in a (4). Thus, interventions to preserve or tile for age and sex but ,50 kg/m2,IGT central laboratory at the University of improve b-cell function in youth are or recently diagnosed (,6 months dura- Washington as summarized below and critically needed. tion) type 2 diabetes, and Tanner stage described in greater detail elsewhere (9). Metformin and insulin each has been $II (females, Tanner stage $II breast Medication adverse effects, symptoms showntoimproveb-cell function in development; and males, testicular vol- of hypoglycemia and hyperglycemia, and adults with impaired glucose tolerance ume .3mL) were eligible. Screening in- adherence (returned medication bottle (IGT) or recent-onset type 2 diabetes. The cluded a history and physical examination, pill count, returned insulin pen residual Diabetes Prevention Program (DPP) dem- laboratory tests, and a 75-g oral glucose volume) were assessed at all study visits. A onstrated that metformin improves b-cell tolerance test (OGTT). Eligibility criteria detailed algorithm was used for address- function and reduces diabetes progres- included the simultaneous presence of ing hypoglycemia, hyperglycemia, and sion by 31% over 3 years in adults with all the following: negative GAD and IA2 acute metabolic decompensation at each IGT (5,6). Weng et al. (7) showed in adults autoantibodies, fasting glucose $5 mmol/L, visit (Supplementary Study Methods). If $ with newly diagnosed type 2 diabetes OGTT 2-h glucose 7.8 mmol/L, and protocol-specified HbA1c safety thresh- that ,2 weeks of intensive insulin ther- HbA1c #8.0% (64 mmol/mol) if drug olds were exceeded at any visit, outcome apy improves and maintains b-cell func- na¨ıve. In youth with type 2 diabetes al- assessments were performed whenever tion, resulting in prolonged remission ready taking metformin, eligibility was possible. The participant was then with- from requiring diabetes medication. modified to HbA1c #7.5% (58 mmol/mol) drawn from the study and referred for Whether such interventions have similar if on metformin for ,3 months and additional diabetes treatment as appropri- benefits in youth is unclear. The Re- #7.0% (53 mmol/mol) if on metformin ate. Safety was monitored by an indepen- storing Insulin Secretion (RISE) Pediatric for 3–6 months. dent data and safety monitoring board. Medication Study was designed as a Final eligibility required $80% com- proof-of-principle trial to test in youth pliance with 3 weeks of placebo medi- Procedures and Calculations across a continuum of b-cell dysfunction cation (or study-provided metformin if A two-step hyperglycemic clamp (11.1 from IGT to mild, recently diagnosed already taking metformin) and atten- mmol/L, .25 mmol/L) paired with the type 2 diabetes the hypothesis that initial dance at scheduled run-in visits. Eligi- insulin secretagogue arginine at the short-term treatment with insulin glargine ble participants underwent a baseline second step was performed at baseline, for 3 months followed by metformin for hyperglycemic clamp and OGTT followed 12 months, and 15 months as previously 9 months would preserve or improve b-cell by random 1:1 treatment assignment by described (8–10). If the participant was function compared with metformin alone, study site, stratified by glycemic status. on metformin, the last dose of metformin with a sustained effect after withdrawal was taken the evening before the hy- of therapy. Interventions perglycemic clamp. The hyperglycemic The glargine followed by metformin clamp was used to quantify simulta- RESEARCH DESIGN AND METHODS groupreceived3monthsofinsulinglar- neouslyinsulinsensitivity(M/I)andthree Study Protocol gine titrated at least twice weekly by a b-cell response measures: 1)steady- The RISE Pediatric Medication Study preset algorithm (Supplementary Study state (second-phase) C-peptide, 2)acute was a four-center, randomized, open- Methods) to achieve a fasting glucose C-peptide response to arginine at maximal label clinical trial funded by the National of 4.4–5.0 mmol/L on the basis of daily glycemic potentiation (ACPRmax), and 3) Institute of Diabetes and Digestive and self-monitored blood glucose (SMBG) acute (first-phase) C-peptide response Kidney Diseases. The rationale and meth- (Freestyle Lite, Abbott Laboratories, Lake to glucose (ACPRg). M/I was calculated ods have been described in detail else- Bluff, IL), which was followed immediately as the mean glucose infusion rate (M) at where (8–10); additional specifics are by 9 months of metformin (titrated to 100, 110, and 120 min of the clamp provided in the Supplementary Data. 1,000 mg twice daily). Youth already divided by the corresponding mean steady- Each center’s institutional review board taking metformin and randomized to state plasma insulin concentration (I) approved the protocol. Written parental glargine therapy discontinued active (11–13). Mean steady-state (second- consent and child assent were obtained metformin at the time of initiation of phase) C-peptide and insulin concentra- consistent with the Declaration of Helsinki glargine treatment. The metformin group tions were calculated at 100, 110, and and each center’s institutional review received metformin alone (titrated to
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