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Pediatric Type 2 Diabetes Mellitus Medication

  • Author: Alba Morales Pozzo, MD; Chief Editor: Stephen Kemp, MD, PhD  more...
 
Updated: May 12, 2014
 

Medication Summary

In general, the treatment of type 2 diabetes in children follows the same rationale as does treatment for the disease in adults. The safety and efficacy of oral hypoglycemic therapy in children and adolescents with type 2 diabetes have not been established; however, physicians have prescribed drugs typically used in adults to treat children and adolescents. Among all of the drugs currently in use to treat type 2 diabetes in adults, the US Food and Drug Administration (FDA) has approved only metformin and insulin for use in children.

The FDA has issued an early communication to health care practitioners regarding 4 published observational studies that describe the possible association of insulin glargine (Lantus) with an increased risk of cancer.[49] Insulin glargine is a long-acting human insulin analogue approved for once-daily dosing.

The observational studies evaluated large patient databases, and all reported some association between insulin glargine and other insulin products with various types of cancer. The duration of the observational studies was shorter than that which is considered necessary to evaluate for drug-related cancers. Additionally, findings were inconsistent within and across the studies, and patient characteristics differed across treatment groups. These issues raise further questions about the actual risk of using insulin glargine and, therefore, concerns about the drug warrant further evaluation.

The FDA states that patients should not stop taking insulin without consulting their physician. An ongoing review by the FDA will continue to update the medical community and consumers with additional information as it emerges. Statements from the American Diabetes Association and the European Association for the Study of Diabetes called the findings conflicting and inconclusive and cautioned against overreaction.

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Biguanides

Class Summary

These agents reduce hepatic glucose production; they also increase peripheral insulin sensitivity. Metformin rarely induces hypoglycemia. Because of its anorexigenic effects, many treated children maintain or lose weight. Since metformin can lead to ovulatory cycles and resumption of regular menses in patients with PCOS, appropriate counseling should be provided to sexually active adolescents.

Kooy et al found improved body weight, glycemic control, and insulin requirements when metformin was added to insulin in type 2 diabetes mellitus. No improvement of an aggregate of microvascular and macrovascular morbidity and mortality was observed; however, risk reduction of macrovascular disease was evident after a follow-up period of 4.3 years. Because of these sustained beneficial effects, the policy to continue metformin treatment after the introduction of insulin in type 2 diabetes mellitus should be followed unless contraindicated.[50]

Metformin (Glucophage, Glumetza, Riomet, Fortamet)

 

Metformin use frequently results in weight loss and mild improvement of all aspects of the lipid profile. It cannot be used in renal or hepatic insufficiency or decompensated congestive heart failure requiring pharmacologic therapy (due to an increased risk for lactic acidosis).

Metformin can be used as monotherapy or with sulfonylureas, glitazones, or insulin. It reduces hepatic glucose output, may decrease intestinal absorption of glucose, and may increase glucose uptake in peripheral tissues. It is a major drug used in obese patients with type 2 diabetes.

Because of adverse gastrointestinal (GI) effects from metformin, titrate the drug slowly and have patients take the medication during (rather than before) meals. Many patients tolerate metformin best if it is administered in the middle or at the end of the meal. The drug is available in immediate-release (IR) or extended-release (ER) form. Only the IR form has been approved for children.

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Sulfonylureas

Class Summary

These agents promote insulin release from the pancreas.

Chlorpropamide

 

Chlorpropamide may increase insulin secretion from pancreatic beta cells.

Glipizide (Glucotrol, Glucotrol XL)

 

Glipizide is a second-generation sulfonylurea that stimulates the release of insulin from pancreatic beta cells.

Glyburide (DiaBeta, Glynase, PresTab)

 

Glyburide is a second-generation sulfonylurea. It may be started at a high dose in patients with severe hyperglycemia and in those with symptoms, if home glucose monitoring and close follow-up can be arranged.

Tolbutamide

 

Tolbutamide increases insulin secretion from pancreatic beta cells.

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Meglitinides

Class Summary

These agents promote short-term insulin secretion from the pancreas and are designed to be taken immediately before meals.

Repaglinide (Prandin)

 

Stimulates insulin release from pancreatic beta cells.

Nateglinide (Starlix)

 

Nateglinide is an amino acid derivative that stimulates insulin secretion from the pancreas (within 20 minutes of oral administration), which, in turn, reduces blood glucose levels. The drug's action depends on functional beta cells in pancreatic islets. Nateglinide interacts with the adenosine triphosphate (ATP) ̶ sensitive potassium channel on pancreatic beta cells.

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Alpha-glucosidase inhibitors

Class Summary

These agents lower postprandial glucose by slowing glucose absorption and delaying the hydrolysis of ingested complex carbohydrates and disaccharide. They must be taken immediately before meals.

Acarbose (Precose)

 

Acarbose delays the hydrolysis of ingested complex carbohydrates and disaccharides and the absorption of glucose. It inhibits the metabolism of sucrose to glucose and fructose.

Miglitol (Glyset)

 

Miglitol delays glucose absorption in the small intestine and lowers postprandial hyperglycemia.

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Thiazolinediones (glitazones)

Class Summary

The first of this class, troglitazone, was removed from the US market due to fatal hepatic necrosis. Rosiglitazone is an antidiabetic agent (thiazolidinedione derivative) that improves glycemic control by enhancing insulin sensitivity. The drug is a potent, highly selective agonist for the peroxisome proliferator-activated receptor-gamma (PPAR-gamma). Activation of PPAR-gamma receptors regulates insulin-responsive gene transcription involved in glucose production, transport, and use, thereby reducing blood glucose concentrations and reducing hyperinsulinemia. Potent PPAR-gamma agonists have been shown to increase the incidence of edema.[51, 52]

A meta-analysis reported an increased risk of myocardial infarction and heart-related death in patients treated with rosiglitazone. The report prompted the FDA to issue an alert on May 21, 2007, to patients and healthcare professionals, enjoining patients to discuss the issue with their physician in order to make individualized decisions regarding their care. A large-scale phase IV trial specifically designed to study cardiovascular outcomes of rosiglitazone is under way. Whether this warning also applies to the other thiazolidinediones (eg, pioglitazone) is unknown.

As of September 2010, the FDA was requiring a restricted access program to be developed for rosiglitazone under a risk evaluation and mitigation strategy (REMS). Patients currently taking rosiglitazone and benefiting from the drug will be able to continue if they choose to do so. Rosiglitazone will only be available to new patients if they are unable to achieve glucose control on other medications and are unable to take pioglitazone, the only other thiazolidinedione.

Results from the RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes) trial indicated that the use of rosiglitazone for type 2 diabetes mellitus increases the risk of heart failure. In the study, cardiovascular outcomes were assessed after adding rosiglitazone to metformin or sulfonylurea regimens for type 2 diabetes mellitus.[53] The study was a multicenter, open-label trial that included 4447 patients with mean HbA1c of 7.9%. Follow-up of the 2 combinations took place over 5-7 years.

No difference was observed between the 2 groups for cardiovascular death, myocardial infarction, and stroke; 61 patients who received rosiglitazone experienced heart failure that caused either hospital admission or death compared with 29 patients in the active control group.

Noncardiovascular adverse effects in the study included increased upper and distal lower limb fracture rates, particularly in women. At 5 years, mean HbA1c was lower in the rosiglitazone group compared with the active control group. In addition to finding that the use of rosiglitazone for type 2 diabetes mellitus increases the risk of heart failure, the study found that the drug increases the risk for select fractures, particularly in women.

For more information, see the FDA’s Safety Alert on Avandia. The online meta-analysis is titled " Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. " Additionally, responses to the controversy can be viewed at the Heartwire news (theheart.org from WebMD) including the following articles:

- " Rosiglitazone increases MI and CV death in meta-analysis. "

- " The rosiglitazone aftermath: Legitimate concerns or hype? "

- " RECORD interim analysis of rosiglitazone safety: No clear-cut answers. "

Rosiglitazone (Avandia)

 

Rosiglitazone is available only via a restricted access program. It is an insulin sensitizer with a major effect in the stimulation of glucose uptake in skeletal muscle and adipose tissue. It lowers plasma insulin levels and is used to treat type 2 diabetes associated with insulin resistance.

Pioglitazone (Actos)

 

Pioglitazone improves target cell response to insulin without increasing insulin secretion from the pancreas. It decreases hepatic glucose output and increases insulin-dependent glucose use in skeletal muscle and, possibly, in liver and adipose tissue.

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Glucagon-like Peptide-1 (GlP-1) Receptor Agonists

Class Summary

Exenatide enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.

Exenatide (Byetta)

 

Exenatide is an incretin mimetic agent that mimics glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins. It improves glycemic control in patients with type 2 diabetes mellitus by enhancing glucose-dependent insulin secretion by pancreatic beta cells. It also suppresses inappropriately elevated glucagon secretion and slows gastric emptying. The drug's 39–amino acid sequence partially overlaps that of the human incretin, glucagonlike peptide-1. Exenatide is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes who are taking metformin or a sulfonylurea but who have not achieved glycemic control.

Liraglutide (Victoza)

 

Liraglutide is an incretin mimetic agent that elicits glucagonlike peptide-1 (GLP-1) receptor agonist activity. It activates the GLP-1 receptor by stimulating G-protein in pancreatic beta cells. Liraglutide increases intracellular cyclic adenosine monophosphate (AMP), leading to insulin release in the presence of elevated glucose concentrations. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The drug has not been studied in combination with insulin.

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Amylin analogue

Class Summary

This agent is a synthetic analogue of human amylin, a naturally occurring hormone made in pancreatic beta cells. It slows gastric emptying, suppresses postprandial glucagon secretion, and regulates food intake through centrally mediated appetite modulation. It is indicated to treat type 1 and type 2 diabetes in combination with insulin. This agent is administered before mealtime for patients who have not achieved desired glucose control despite optimal insulin therapy. It helps to achieve lower blood glucose levels after meals, less fluctuation of blood glucose levels during the day, and improvement of long-term control of glucose levels (ie, HbA1C levels), compared with insulin alone. Less insulin use and a reduction in body weight are also observed.

Pramlintide (Symlin)

 

Pramlintide is a synthetic analogue of human amylin, a naturally occurring hormone made in pancreatic beta cells. It slows gastric emptying, suppresses postprandial glucagon secretion, and regulates food intake through centrally mediated appetite modulation. The drug is indicated to treat type 1 and type 2 diabetes in combination with insulin. It is administered before mealtime for patients who have not achieved desired glucose control despite optimal insulin therapy. Pramlintide helps to achieve lower blood glucose levels after meals, less fluctuation of blood glucose levels during the day, and improvement of long-term control of glucose levels (ie, HbA1C levels), compared with insulin alone. Less insulin use and a reduction in body weight are also observed.

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Dipeptidyl peptidase IV (DPP-4) inhibitors

Class Summary

These agents block the action of DDP-4, which is known to degrade incretin. DDP-4 inhibitors have not yet gained FDA approval for use in children.

Linagliptin (Tradjenta)

 

Linagliptin increases and prolongs incretin hormone activity, which is inactivated by the DPP-4 enzyme. It is indicated, along with diet and exercise, for adults with type 2 diabetes mellitus, to lower blood sugar. Linagliptin may be used as monotherapy or in combination with other common antidiabetic medications, including metformin, sulfonylurea, and pioglitazone. It has not been studied in combination with insulin.

Sitagliptin (Januvia)

 

Sitagliptin blocks the enzyme DPP-4, which is known to degrade incretin hormones. It increases concentrations of active intact incretin hormones (GLP-1, GIP). The hormones stimulate insulin release in response to increased blood glucose levels following meals. This action enhances glycemic control. Sitagliptin is indicated for type 2 diabetes as monotherapy or is combined with metformin or with a PPAR-gamma agonist (eg, thiazolidinediones).

Saxagliptin (Onglyza)

 

Saxagliptin blocks DPP-4, which is known to degrade incretin hormones, increasing concentrations of active intact incretin hormones (GLP-1 and GIP). The hormones stimulate insulin release in response to increased blood glucose levels following meals. This action enhances glycemic control. Saxagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

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Contributor Information and Disclosures
Author

Alba Morales Pozzo, MD Associate Professor, Department of Pediatrics, Division of Endocrinology and Diabetes, University of Arkansas for Medical Sciences

Alba Morales Pozzo, MD is a member of the following medical societies: American Academy of Pediatrics, American Medical Association, Arkansas Medical Society, Endocrine Society, Pediatric Endocrine Society

Disclosure: Nothing to disclose.

Specialty Editor Board

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

George P Chrousos, MD, FAAP, MACP, MACE, FRCP(London) Professor and Chair, First Department of Pediatrics, Athens University Medical School, Aghia Sophia Children's Hospital, Greece; UNESCO Chair on Adolescent Health Care, University of Athens, Greece

George P Chrousos, MD, FAAP, MACP, MACE, FRCP(London) is a member of the following medical societies: American Academy of Pediatrics, American College of Physicians, American Pediatric Society, American Society for Clinical Investigation, Association of American Physicians, Endocrine Society, Pediatric Endocrine Society, Society for Pediatric Research, American College of Endocrinology

Disclosure: Nothing to disclose.

Chief Editor

Stephen Kemp, MD, PhD Former Professor, Department of Pediatrics, Section of Pediatric Endocrinology, University of Arkansas for Medical Sciences College of Medicine, Arkansas Children's Hospital

Stephen Kemp, MD, PhD is a member of the following medical societies: American Academy of Pediatrics, American Association of Clinical Endocrinologists, American Pediatric Society, Endocrine Society, Phi Beta Kappa, Southern Medical Association, Southern Society for Pediatric Research

Disclosure: Nothing to disclose.

Additional Contributors

Arlan L Rosenbloom, MD Adjunct Distinguished Service Professor Emeritus of Pediatrics, University of Florida College of Medicine; Fellow of the American Academy of Pediatrics; Fellow of the American College of Epidemiology

Arlan L Rosenbloom, MD is a member of the following medical societies: American Academy of Pediatrics, American College of Epidemiology, American Pediatric Society, Endocrine Society, Pediatric Endocrine Society, Society for Pediatric Research, Florida Chapter of The American Academy of Pediatrics, Florida Pediatric Society, International Society for Pediatric and Adolescent Diabetes

Disclosure: Nothing to disclose.

Acknowledgements

The authors and editors of Medscape Reference gratefully acknowledge the contributions of previous author Jean-Claude DesMangles, MD,to the development and writing of the source article.

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Simplified scheme for the pathophysiology of type 2 diabetes mellitus.
 
 
 
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