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Treating Postprandial Hyperglycemia Does Not Appear to Delay Progression of Early Type 2 Diabetes

The Early Diabetes Intervention Program

¹ Indiana University School of Medicine, Indianapolis, Indiana
² Roudebush VA Medical Center, Indianapolis Indiana
³ Amylin Pharmaceuticals, San Diego California
⁴ Washington University School of Medicine, St. Louis, Missouri

Address correspondence and reprint requests to M. Sue Kirkman, MD, 545 Barnhill Dr., EH 421, Indianapolis, IN 46202. E-mail: mkirkman{at}iupui.edu

OBJECTIVE—Postprandial hyperglycemia characterizes early type 2 diabetes. We investigated whether ameliorating postprandial hyperglycemia with acarbose would prevent or delay progression of diabetes, defined as progression to frank fasting hyperglycemia, in subjects with early diabetes (fasting plasma glucose [FPG] <140 mg/dl and 2-h plasma glucose 200 mg/dl).

RESEARCH DESIGN AND METHODS—Two hundred nineteen subjects with early diabetes were randomly assigned to 100 mg acarbose t.i.d. or identical placebo and followed for 5 years or until they reached the primary outcome (two consecutive quarterly FPG measurements of 140 mg/dl). Secondary outcomes included measures of glycemia (meal tolerance tests, HbA_1c, annual oral glucose tolerance tests [OGTTs]), measures of insulin resistance (homeostasis model assessment [HOMA] of insulin resistance and insulin sensitivity index from hyperglycemic clamps), and secondary measures of ß-cell function (HOMA-ß, early- and late-phase insulin secretion, and proinsulin-to-insulin ratio).

RESULTS—Acarbose significantly reduced postprandial hyperglycemia. However, there was no difference in the cumulative rate of frank fasting hyperglycemia (29% with acarbose and 34% with placebo; P = 0.65 for survival analysis). There were no significant differences between groups in OGTT values, measures of insulin resistance, or secondary measures of ß-cell function. In a post hoc analysis of subjects with initial FPG <126 mg/dl, acarbose reduced the rate of development of FPG 126 mg/dl (27 vs. 50%; P = 0.04).

CONCLUSIONS—Ameliorating postprandial hyperglycemia did not appear to delay progression of early type 2 diabetes. Factors other than postprandial hyperglycemia may be greater determinants of progression of diabetes. Alternatively, once FPG exceeds 126 mg/dl, ß-cell failure may no longer be remediable.

Abbreviations: AUC, area under the curve • DPP, Diabetes Prevention Program • EDIP, Early Diabetes Intervention Program • FPG, fasting plasma glucose • HOMA-ß, homeostasis model assessment of ß-cell function • HOMA-IR, homeostasis model assessment of of insulin resistance • IGT, impaired glucose tolerance • MPS, meal profile study • OGTT, oral glucose tolerance test • STOP-NIDDM, Study to Prevent NIDDM • UKPDS, U.K. Prospective Diabetes Study Group

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