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Oral agents offer glycemic control, improved beta-cell function in severe hyperglycemia
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The combination DPP-IV inhibitor plus metformin Kombiglyze XR was as effective as glipizide XL in lowering blood glucose and improving beta-cell function in patients with newly diagnosed type 2 diabetes and severe hyperglycemia, according to study results.
Ambika Amblee, MD, attending physician in the department of endocrinology at Cook County Health and Hospitals System in Chicago, and colleagues evaluated data from 100 adults with type 2 diabetes duration less than 1 year who presented to an acute care site with severe hyperglycemia (300-450 mg/dL). Patients were randomly assigned 1:1 to treatment with daily Kombiglyze XR (saxagliptin 5 mg/metformin 2,000 mg, AstraZeneca) or to a control group with glipizide XL (10 mg) for 12 weeks to determine the effectiveness of each agent on glycemic and beta-cell outcomes.
Glucose declined from baseline 343 mg/dL to 250 mg/dL by the end of the first week and to 137 mg/dL by week 12 in the saxagliptin/metformin group and from baseline 341 mg/dL to 243 mg/dL by the end of the first week and to 129 mg/dL at week 12 in the glipizide group. At week 12, 54% of the saxagliptin/metformin group and 66% of the glipizide group reached blood glucose goals of 80 mg/dL to 130 mg/dL.
At week 12, researchers observed a 5.8-fold improvement in homeostasis model of assessment (HOMA) for beta-cell function in the saxagliptin/metformin group and a 5.9-fold improvement in the glipizide group. Early insulin response increased 9.5-fold in the saxagliptin group and 13.1-fold in the glipizide group. HOMA for insulin resistance declined from baseline in the saxagliptin/metformin group (P = .001) and in comparison with the glipizide group at week 12 (P = .03). Insulin area under the curve (AUC) during oral glucose tolerance testing improved from baseline 2.1-fold in the saxagliptin/metformin group and 2.5-fold in the glipizide group (P < .001 for both); glucose AUC decreased 47.3% in the saxagliptin/metformin group and 43.6% in the glipizide group (P < .0001 for both). Hypoglycemia rates with self-monitoring of blood glucose and continuous glucose monitoring were lower in the saxagliptin/metformin group compared with the glipizide group (8% vs. 24% and 20% vs. 46.5%, respectively). No participants reported severe hypoglycemia or hypoglycemia less than 50 mg/dL.
“This study suggests that in most patients with newly diagnosed [type 2 diabetes] who present to acute care sites with severe hyperglycemia, oral medications like glipizide XL and Kombiglyze XR offer an effective and simple regimen as an alternative to more cumbersome insulin therapy and can achieve early glycemic control,” the researchers wrote. “The results of this and previous studies suggest that future [American Diabetes Association] guidelines in relation to initiation therapy in patients with newly diagnosed [type 2 diabetes] with severe hyperglycemia could also include noninsulin alternatives.” – by Amber Cox
Disclosure: Amblee reports receiving grant support from AstraZeneca. Please see the full study for a list of all other authors’ relevant financial disclosures.
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