Reduction of glycosylated hemoglobin and postprandial hyperglycemia by acarbose in patients with NIDDM. A placebo-controlled dose-comparison study

• Published in: Diabetes care Vol. 18; no. 6; pp. 817 - 824
• Main Authors: CONIFF, R. F, SHAPIRO, J. A, ROBBINS, D, KLEINFIELD, R, SEATON, T. B, BEISSWENGER, P, CMGILL, J. B
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Alexandria, VA American Diabetes Association 01-06-1995
• Subjects: Acarbose; Adult; Analysis of Variance; Biological and medical sciences; Blood Glucose - drug effects; Blood Glucose - metabolism; Cholesterol - blood; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - diet therapy; Diabetes Mellitus, Type 2 - drug therapy; Diet, Diabetic; Dose-Response Relationship, Drug; Double-Blind Method; Eating; Energy Intake; Female; General and cellular metabolism. Vitamins; Glycated Hemoglobin A - analysis; Glycated Hemoglobin A - metabolism; Humans; Hyperglycemia - prevention & control; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Insulin - blood; Lipoprotein(a) - blood; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Placebos; Time Factors; Triglycerides - blood; Trisaccharides - adverse effects; Trisaccharides - therapeutic use; Uric Acid - blood; Endocrinopathy; Human; Chemotherapy; Hyperglycemia; Treatment; Postprandial; Treatment efficiency; Hemoglobin A1; Non insulin dependent diabetes
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/diacare.18.6.817

Reduction of glycosylated hemoglobin and postprandial hyperglycemia by acarbose in patients with NIDDM. A placebo-controlled
dose-comparison study.
R F Coniff ,
J A Shapiro ,
D Robbins ,
R Kleinfield ,
T B Seaton ,
P Beisswenger and
J B McGill
Department of Medical Affairs, Bayer Corporation, West Haven, Connecticut, USA.
Abstract
OBJECTIVE--To compare the safety and efficacy of three doses of acarbose (100, 200, and 300 mg three times daily) with placebo
for the treatment of non-insulin-dependent diabetes mellitus (NIDDM) in patients maintained on dietary therapy alone. RESEARCH
DESIGN AND METHODS--This multicenter double-blind placebo-controlled trial was 22 weeks in duration. The trial consisted of
a 2-week screening period, a 4-week placebo run-in period, and a 16-week double-blind treatment period. The primary measure
of drug efficacy was the mean change from baseline in HbA1c levels. Additional efficacy variables included the mean change
from baseline in fasting and postprandial plasma glucose and serum insulin levels. RESULTS--After 16 weeks of treatment, acarbose-treated
patients had statistically significant reductions in mean HbA1c levels of 0.78, 0.73, and 1.10% (relative to placebo) in the
100-, 200-, and 300-mg t.i.d. groups, respectively. Significant reductions in fasting and postprandial plasma glucose levels,
glucose area under the time-concentration curve, and maximum glucose concentration were also observed in acarbose-treated
patients. Although there were no statistically significant differences among the 100-, 200-, and 300-mg treatment groups,
there was a trend toward a dose-response relationship for most plasma glucose variables that were measured. Gastrointestinal
side effects (e.g., abdominal pain, flatulence, and diarrhea) and serum transaminase elevations (e.g., aspartate aminotransferase
[AST] and alanine aminotransferase [ALT] were more frequently reported in the acarbose-treated patients than in the placebo-treated
control patients. Transaminase elevations occurred only at the 200-, and 300-mg dosages and were readily reversible on discontinuation
of treatment. CONCLUSIONS--Acarbose at doses of 100, 200, and 300 mg administered three times daily for 16 weeks significantly
reduced HbA1c levels and postprandial hyperglycemia. Treatment with acarbose is a safe and effective adjunct to dietary therapy
for the treatment of NIDDM.