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Combined Insulin Glargine and Metformin Therapy Treats Obese Type 2 Diabetics: Presented at ADA

By Jill Stein
Special to DG News

SAN FRANCISCO, CA -- June 18, 2002 -- Treatment of obese patients with type 2 diabetes with a combination of insulin glargine (Lantus) and metformin improves glycemic control without causing hypoglycemia, a German group reported here Monday.

Speaking at the 62^nd Scientific Sessions of the American Diabetes Association (ADA), the researchers said that this combination also has beneficial effects on lipid profiles, which has positive implications when considering the long-term health of these patients. The combination also had a minimal effect on body weight.

"The introduction of insulin analogs is a major clinical breakthrough in the management of diabetes," said Dr. Danuta Stryjek-Kaminska, with the German Diagnostic Clinic in Wiesbaden. Insulin glargine, a long-acting, once-daily human insulin analog, has been shown to have a unique, smooth action profile with no pronounced peaks.

Improved metabolic control without weight gain poses a major challenge in the management of patients with type 2 diabetes.

Prior studies have shown that insulin glargine improves metabolic control, has a favorable weight profile, and reduces the risk of nocturnal hypoglycemia in patients with type 2 diabetes.

Metformin, an oral antihyperglycemic agent, is a biguanide agent that increases peripheral insulin sensitivity, inhibits hepatic gluconeogenesis, reduces hepatic glucose production, and generally allows weight loss.

Since the pathogenesis of type 2 diabetes involves both impaired insulin secretion and increased insulin resistance, the German researchers theorized that a synergistic combination of insulin glargine and metformin might improve glycemic control, and yield a more favorable metabolic profile than when either drug is used alone. The purpose of their study was to determine the efficacy and safety of the combination for the treatment of obese patients with type 2 diabetes in whom dietary measures, weight control, and oral anti-diabetic agents had failed.

Forty- two obese patients with type 2 diabetes, with a mean age of 53 years, were observed over a 12-week period during which they were treated with insulin glargine/metformin therapy. They were all treated with subcutaneous insulin glargine, taken once daily at bedtime, and individually titrated, and metformin 850 mg twice daily.

After 12 weeks, there was a statistically significant decrease in mean hemoglobin A1c level from 9.8 percent at baseline to 8.2 percent at end point (p<0.001). A significant reduction in mean total cholesterol level was also seen, from 217 mg/dL to 191 mg/dL (p<0.05). Mean triglyceride levels were also reduced significantly (238 mg/dL to 207 mg/dL, p<0.03). No hypoglycemic episodes were reported.

Following 12 weeks of treatment with insulin glargine plus metformin, there was a mean change in body weight of 0.2 +/- 1.6 kg. However, this difference was not significant.

Adverse effects documented during the study were generally mild or moderate. In the first week of therapy, six patients developed adverse events associated with metformin use (diarrhea, metallic taste, abdominal discomfort); however, none of the patients withdrew from the study.

Dr. Stryjek-Kaminska concluded these results suggest that co-administration of insulin glargine with metformin could be beneficial for obese patients with type 2 diabetes who cannot be controlled with oral agents alone and who can tolerate metformin.

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