Evaluating sitagliptin in combination with pre-mixed insulin for poorly controlled Type 2 diabetes

This study evaluated the safety and effectiveness of adding sitagliptin (Januvia) to treatment with pre-mixed insulin in patients with poorly controlled Type 2 diabetes (T2D). This study concluded that sitagliptin was well-tolerated and significantly improved glycemic (blood sugar) control in these patients.

As T2D progresses, more intense treatment may be required. Many patients with T2D eventually need second-line anti-diabetic drugs for better glycemic (blood sugar) control. These can be added to insulin therapy to help reduce hypoglycemia (very low blood sugar) between meals.

Sitagliptin is a DPP-4 inhibitor. This type of treatment increases the production of a hormone called incretin. This hormone is made by the body during meals. Incretin raises insulin levels when blood glucose levels are high, which helps reduce blood glucose levels. Sitagliptin is approved for use in combination with insulin. The safety and efficacy of adding sitagliptin to patients with poorly controlled T2D who are using pre-mixed insulin remain under investigation.

This study involved the clinical trial data of 519 patients with poorly controlled T2D. These patients were already using pre-mixed insulin with or without metformin (Glucophage). Patients received either sitagliptin (50.5%) or placebo (a substance with no active effect; 49.5%). 

After 24 weeks of treatment, patients in the sitagliptin group who were taking pre-mixed insulin had a significant reduction of 0.43% in HbA1c (average blood glucose over 3 months) compared to placebo.

Fasting blood glucose (blood glucose levels after fasting) significantly decreased by 5.3 mg/dL in the sitagliptin group compared to placebo. Blood glucose levels 2 hours after eating a meal significantly decreased by 31.7 mg/dL in the sitagliptin group compared to placebo.

Overall, 55.3% of all patients reported side effects. Most side effects were mild. 27.5% (sitagliptin) and 21.0% (placebo) of patients reported hypoglycemia. Only 1.2% of patients experienced hypoglycemia that required medical attention. All of these were in the placebo group

This study concluded that sitagliptin was well-tolerated and significantly improved glycemic control in patients with poorly controlled Type 2 diabetes. The authors suggest that it can be safely used in combination with pre-mixed insulin.

This study was retrospective, meaning it looked back in time to analyze data. Data was collected from two different studies that were conducted at different times. 72% of the patients in this study were Asian, so these results may not be applicable to all patients.

This study received funding support from Merck & Co., Inc, the manufacturer of sitagliptin.

Talk to your doctor about the option of adding sitagliptin to your treatment regimen.