Joining Forces: A Call for Greater Collaboration to Study New Medicines in Children and Adolescents With Type 2 Diabetes

Karres, Janina; Pratt, Valerie; Guettier, Jean‐Marc; Temeck, Jean; Tamborlane, William V.; Bejnariu, Cristina; Beaufort, Carine de; Tomasi, Paolo

doi:10.2337/dc14-0494

Cited by 25 publications

(28 citation statements)

References 20 publications

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“…Clinical trials were hampered by the multiple challenges of sufficient sample size, cost of travel to study centres from remote communities, elevated liver enzymes due to steatosis, psychosocial co-morbidities, and complex ethics of informed consent in children (Karres et al 2014). There was anecdotal evidence of the effectiveness of lifestyle monotherapy in a supportive environment such as summer camp (Anderson and Dean 1990) or progressive communities (Wittmeier et al 2012).…”

Section: -2005: the Decade Of Growing International Interestmentioning

confidence: 99%

Children have type 2 diabetes too: an historical perspective

Dean

Sellers

2015

Biochem. Cell Biol.

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Prior to 1985, type 2 diabetes was a disease of adults. Simultaneously with the global epidemic of childhood obesity, type 2 diabetes has increased in children. Initially, the presentation of small case series of type 2 diabetes in children was met with skepticism. As the number and size of the case series grew and the first long-term outcomes of end-stage complications in young adults appeared in the literature, the international community took notice with guarded interest. Type 2 diabetes disproportionately affects the children of specific ethnic groups and from disadvantaged socioeconomic environments, especially Indigenous populations. The past decade has seen unprecedented intense global interest in the etiology, treatment, and prevention of type 2 diabetes in children.

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Section: -2005: the Decade Of Growing International Interestmentioning

confidence: 99%

Children have type 2 diabetes too: an historical perspective

Dean

Sellers

2015

Biochem. Cell Biol.

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“…In 2014, it was estimated that conducting all of the individual pediatric T2D studies that companies have agreed to with the regulatory agencies will require up to 3,800 pediatric patients (5), and this number continues to increase with every new study proposal. Having been first recognized in the 1990s, pediatric T2D is an epidemic in relative rather than absolute terms, and the number of pediatric patients with T2D remains small compared with the number of patients with T1D.…”

Section: Part 1: the Challengesmentioning

confidence: 99%

“…Leaders at the EMA and FDA have recognized that innovative approaches to the design of regulatory studies that address feasibility and recruitment issues in pediatric T2D are needed (5). An innovative approach presented by James Wason, MRC Biostatistics Unit Hub for Trials Methodology Research, Cambridge, U.K., at the EMA Workshop in 2013 would use simultaneous multi-agent/multicompany pivotal trials carried out by independent networks of leading academic pediatric diabetes treatment centers in the U.S., Europe, Australia, and elsewhere (11).…”

Section: Part 2: Innovative Approaches and Novel Study Designsmentioning

confidence: 99%

Expanding Treatment Options for Youth With Type 2 Diabetes: Current Problems and Proposed Solutions

Tamborlane¹,

Haymond

Shankar³

et al. 2016

Diabetes Care

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“…The need for quick action to address the lack of therapeutic options that target the various pathophysiological mechanisms for T2D in youth has led to the formation of collaborative efforts. Involved parties include the U.S. Food and Drug Administration, the European Network of Pediatric Research at the European Medicines Agency, the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Diabetes Working Group, and pharmaceutical companies working to collect efficacy and safety clinical trial data to inform treatment algorithms …”

Section: Treatment Of T2d In Youthmentioning

confidence: 99%

The changing face of diabetes in youth: lessons learned from studies of type 2 diabetes

Hannon

Arslanian

2015

Annals of the New York Academy of Sciences

115

104

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The incidence of youth type 2 diabetes (T2D), linked with obesity and declining physical activity in high-risk populations, is increasing. Recent multicenter studies have led to a number of advances in our understanding of the epidemiology, pathophysiology, diagnosis, treatment, and complications of this disease. As in adult T2D, youth T2D is associated with insulin resistance, together with progressive deterioration in ␤ cell function and relative insulin deficiency in the absence of diabetes-related immune markers. In contrast to adult T2D, the decline in ␤ cell function in youth T2D is three-to fourfold faster, and therapeutic failure rates are significantly higher in youth than in adults. Whether the more aggressive nature of youth T2D is driven by genetic heterogeneity or physiology/metabolic maladaptation is yet unknown. Besides metformin, the lack of approved pharmacotherapeutic agents for youth T2D that target the pathophysiological mechanisms is a major barrier to optimal diabetes management. There is a significant need for effective therapeutic options, in addition to increased prevention, to halt the projected fourfold increase in youth T2D by 2050 and the consequences of heightened diabetes-related morbidity and mortality at younger ages.

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Joining Forces: A Call for Greater Collaboration to Study New Medicines in Children and Adolescents With Type 2 Diabetes

Cited by 25 publications

References 20 publications

Children have type 2 diabetes too: an historical perspective

Children have type 2 diabetes too: an historical perspective

Expanding Treatment Options for Youth With Type 2 Diabetes: Current Problems and Proposed Solutions

The changing face of diabetes in youth: lessons learned from studies of type 2 diabetes

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