HOUSTON – Off-label use of sitagliptin to treat patients with postprandial hypoglycemia significantly reduced the symptoms of reactive hypoglycemia in a preliminary randomized, controlled, double-blind trial of 28 adults.
The 13 patients who took 100 mg/day of sitagliptin (Januvia) for 2 weeks and the 15 control patients on an identical placebo did not differ in baseline characteristics or in prerandomization measures of insulin and blood sugar levels from 5-hour meal tolerance tests. The 440-calorie meal contained 100 g of carbohydrates, which usually would trigger reactive hypoglycemia symptoms in these patients.
After treatment, the sitagliptin group rated the intensity of reactive hypoglycemia symptoms significantly lower than did the control group – 2 vs. 5 – on a visual analog scale of 1-10, in which 0 represented no symptoms and 10 was greatest symptom intensity, Dr. Paloma Almeda-Valdés and her associates reported in a poster presentation at the annual meeting of the Endocrine Society.
Patients in the sitagliptin group reported significant reductions in the symptoms of anxiety, palpitations, shakiness (tremor), diaphoresis, dizziness, tingling, difficulty concentrating, and weakness, said Dr. Almeda-Valdés of Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City.
Sitagliptin is approved to lower glucose levels in adults with type 2 diabetes. It increases glucagon-like peptide1 circulating levels, which improves the early-phase secretion of insulin.
Meal tolerance tests after 2 weeks of treatment showed that the sitagliptin group had significantly higher levels of insulin within 30 minutes of the test, with areas under the curve of 2,278 mcU/mL per minute compared with 2,106 mcU/mL per minute in the control group.
The increased insulin concentration in this early phase after the meal was associated with significantly higher glucose concentrations later on, 1-5 hours after the meal. The glucose areas under the curve in the late phase of the meal tolerance test were 90,030 mg/dL per minute in the sitagliptin group and 84,165 mg/dL per minute in the control group.
These biochemical changes were associated with the reductions in symptom severity in the sitagliptin group, Dr. Almeda-Valdés said.
"The hypothesis is that sitagliptin restores insulin secretion in these patients, and this was associated with higher glucose levels in the late phase" and thus less hypoglycemia, she said in an interview.
The study defined symptomatic reactive hypoglycemia as the presence of symptoms associated with a 2- to 4-hour postprandial capillary glucose less than 65 mg/dL that disappeared with carbohydrate ingestion.
Merck, which markets sitagliptin, provided funding, the drug, and the placebo for the study. Dr. Almeda-Valdés reported having no other disclosures.