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Beginning Insulin Treatment of Obese Patients With Evening 70/30 Insulin Plus Glimepiride Versus Insulin Alone

  1. Matthew C Riddle, MD,
  2. Jill Schneider, MD and
  3. The Glimepiride Combination Group
  1. Oregon Health Sciences University Portland, Oregon
  2. Hoechst Marion Roussel Pharmaceuticals Somerville, New Jersey
  1. Address correspondence and reprint requests to Matthew C. Riddle, MD, Section of Diabetes L-345, Oregon Health Sciences University, Portland, OR 97201.

Abstract

OBJECTIVE This study tested a simple algorithm for beginning insulin for obese patients with type 2 diabetes after sulfonylurea failure, comparing suppertime 70/30 insulin plus continued glimepiride with insulin alone.

RESEARCH DESIGN AND METHODS This was a multicenter ambulatory randomized double-masked parallel comparison. There were 208 subjects with secondary failure to sulfonylureas who took glimepiride titrated to 8 mg b.i.d. for 8 weeks; 145 subjects with fasting plasma glucose (FPG) 180–300 mg/dl (10–16.7 mmol/1) on this treatment were randomized to placebo plus insulin (PI) or glimepiride plus insulin (GI) for 24 weeks. A dosage of 70/30 insulin before supper was titrated, seeking fasting capillary blood glucose (FBG) 120 mg/dl (6.7 mmol/1), equivalent to FPG 140 mg/dl (7.8 mmol/1). Outcome measures included FPG, HbA1c, insulin dosage, weight, serum insulin and lipids, and adverse events.

RESULTS FPG and HbA1c were equivalent at baseline: 261 vs. 250 mg/dl (14.5 vs. 13.9 mmol/1), and 9.9 vs. 9.7%. At 24 weeks, the FPG target was achieved in both groups (136 vs. 138 mg/dl, 7.6 vs. 7.6 mmol/1), and HbA1c values were equal (7.7 vs. 7.6%). However, with GI, control improved faster and fewer subjects dropped out (3 vs. 15%, P < 0.01), and less insulin was needed (49 vs. 78 U/d, P < 0.001). The outcomes were alike in other respects. No subject had severe hypoglycemia.

CONCLUSIONS Injection of 70/30 insulin before supper safely restored glycemic control of type 2 diabetes not controlled by glimepiride alone. Control was restored more rapidly and with less injected insulin when glimepiride was continued.

  • Received September 15, 1997.
  • Revision received March 18, 1998.
  • Accepted March 18, 1998.
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