Oral medications may control symptoms of Type II diabetes in children just as well as insulin injections, a new study reports.
According to the medical records of 26 children diagnosed with the disease, oral medications reduced levels of a compound in the blood called hemoglobin A1C by an average of 2 percentage points.
A 2-percentage-point reduction is enough to decrease serious health risks and symptoms associated with Type II diabetes, said Milap Nahata, the study's principal investigator and a professor of pharmacy and pediatrics at Ohio State University.
High blood sugar levels leave a diabetic vulnerable to developing heart and kidney disease and vision problems; symptoms include frequent urination and excessive thirst. Diabetics normally show high levels of hemoglobin A1C, which is a marker for blood sugar levels.
"This is the first study to show that oral medications may decrease these levels in children," Nahata said.
The researchers wanted to compare the effectiveness of injected insulin to oral medications in lowering levels of this hemoglobin marker in children. Clear guidelines on the best treatments for children with Type II, or insulin-resistant, diabetes, have yet to be established, said Nahata.
"It's only been within the last 20 years that we've seen large numbers of children developing this disease," he said. "And most oral medications typically prescribed to children with the illness have never been compared to one another or to insulin."
A common side effect of insulin is weight gain, which often discourages medication compliance among teenagers, Nahata said.
The results appear in a recent issue of the journal Pharmacotherapy.
In Type II diabetes the body's cells don't respond to insulin, the hormone that helps the body regulate blood sugar levels.
The researchers gathered five years' worth of hemoglobin A1C values, medication and symptom data from the children's medical records. All of the children lived in central Ohio . The average age was 15 for boys and 14 for girls.
Medications prescribed included insulin for some children and the oral drugs metformin and sulfonylurea. Some children took a combination of the drugs. While insulin and metformin are the only two drugs approved by the Food and Drug Administration for treating children with Type II diabetes, pediatricians have the authority to prescribe a different drug if they think it can do a better job of controlling a patient's disease. It's fairly common practice for doctors to do this, too.
"Fully 80 percent of the drugs on the market have never been studied adequately for use in children," Nahata said.
In the study, the 14 children who were treated with insulin achieved the greatest reduction of the hemoglobin compound – from an average of 11.1 percent to 8.1 percent. Some of these children were also prescribed an oral drug.
"But the children treated with insulin also had the highest values to begin with," Nahata said.
While normal hemoglobin A1C values range from 4 to 6 percent, reaching a value of 7 percent is considered a success for diabetics. But even reducing that value to 8 percent can cause a notable reduction in symptoms and risks associated with Type II diabetes.
According to the American Diabetes Association, the average diabetic has a hemoglobin A1C value of about 9 percent. Untreated, these levels can leave a person at serious risk for developing other health problems.
Values of the compound decreased from an average of 10.6 to 8 percent in the other 12 children who were prescribed the oral drugs only – a reduction comparable to those getting injections.
Half (13) of the children included in the study were able to lower the values of the hemoglobin compound to 7 percent or less. Another three children reduced their values to between 7 and 8 percent.
Type II diabetes is a disease that traditionally strikes overweight and obese adults. But more and more children have developed this disease due to childhood obesity rates nearly doubling in the past 20 years.
"Type II diabetes in children was almost unheard of when I started in pharmacy 30 years ago," Nahata said. "It was supposed to be a disease that adults developed."
Children are usually much more prone to developing Type I, or insulin-dependent, diabetes, a disease in which the pancreas does not produce enough insulin.
While Nahata says the results of this small study are interesting and may apply to the larger population, additional studies that include more patients are needed to compare the effectiveness of the drugs to each other for controlling the illness and its complications.
"We don't yet know what the ideal drug or drug combination is for treating children with Type II diabetes," Nahata said.
Children are at risk of developing Type II diabetes if
- their body mass index (BMI, a measurement that relates weight to height) is above the 85th percentile for their age and sex;
- they weigh 120 percent of their ideal weight;
- have a parent or grandparent who also has the disease;
- are African-American, Native American, Mexican American and Asian or Pacific Islander; and
- show signs of insulin resistance.
Nahata conducted the study with Ohio State colleagues Jeffrey Striet and John Germak and with Sandra Benavides, who is with the University of Texas' Pan American Cooperative Pharmacy Program.