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Long-term efficacy and safety of acarbose in the treatment of obese subjects with non-insulin-dependent diabetes mellitus.
Arch Intern Med. 1994 Nov 14; 154(21):2442-8.AI

Abstract

BACKGROUND

Acarbose delays the release of glucose from complex carbohydrates and disaccharides by inhibiting intestinal alpha-glucosidases, attenuating postprandial increments in blood glucose and insulin. This multicenter double-blind study compared the efficacy and safety of acarbose with placebo in the treatment of obese subjects with non-insulin-dependent diabetes mellitus (NIDDM) managed by diet.

METHODS

Two hundred twelve obese subjects with NIDDM who had not received any diabetic medication for at least 12 weeks were randomized to receive acarbose or placebo. The subjects were stratified by fasting glucose level above or below 11.1 mmol/L (200 mg/dL). Based on the subject's therapeutic response and tolerance, the acarbose dosage was titrated from 50 to 300 mg three times per day. This 36-week study consisted of a 6-week pretreatment period, a 24-week double-blind treatment period, and a 6-week posttreatment period.

RESULTS

Ninety-one subjects given acarbose and 98 subjects who received placebo were evaluable for efficacy. During a standard meal tolerance test at the double-blind end point, the differences between treatment groups in mean change from baseline were as follows: 0.9 mmol/L (16 mg/dL) for fasting plasma glucose level, approximately 2.8 mmol/L (50 mg/dL) for postprandial plasma glucose level, and 0.59% (P < .0001) for hemoglobin A1c concentration (for all three measurements, values decreased in the acarbose group and increased in the placebo group).

CONCLUSIONS

Acarbose improved both fasting and postprandial hyperglycemia and improved overall glycemic control as measured by the hemoglobin A1c level. These findings suggest a beneficial role for acarbose in combination with diet in the treatment of obese subjects with NIDDM.

Authors+Show Affiliations

Department of Metabolics, Miles Inc, West Haven, Conn.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

7979840

Citation

Coniff, R F., et al. "Long-term Efficacy and Safety of Acarbose in the Treatment of Obese Subjects With Non-insulin-dependent Diabetes Mellitus." Archives of Internal Medicine, vol. 154, no. 21, 1994, pp. 2442-8.
Coniff RF, Shapiro JA, Seaton TB. Long-term efficacy and safety of acarbose in the treatment of obese subjects with non-insulin-dependent diabetes mellitus. Arch Intern Med. 1994;154(21):2442-8.
Coniff, R. F., Shapiro, J. A., & Seaton, T. B. (1994). Long-term efficacy and safety of acarbose in the treatment of obese subjects with non-insulin-dependent diabetes mellitus. Archives of Internal Medicine, 154(21), 2442-8.
Coniff RF, Shapiro JA, Seaton TB. Long-term Efficacy and Safety of Acarbose in the Treatment of Obese Subjects With Non-insulin-dependent Diabetes Mellitus. Arch Intern Med. 1994 Nov 14;154(21):2442-8. PubMed PMID: 7979840.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term efficacy and safety of acarbose in the treatment of obese subjects with non-insulin-dependent diabetes mellitus. AU - Coniff,R F, AU - Shapiro,J A, AU - Seaton,T B, PY - 1994/11/14/pubmed PY - 1994/11/14/medline PY - 1994/11/14/entrez SP - 2442 EP - 8 JF - Archives of internal medicine JO - Arch Intern Med VL - 154 IS - 21 N2 - BACKGROUND: Acarbose delays the release of glucose from complex carbohydrates and disaccharides by inhibiting intestinal alpha-glucosidases, attenuating postprandial increments in blood glucose and insulin. This multicenter double-blind study compared the efficacy and safety of acarbose with placebo in the treatment of obese subjects with non-insulin-dependent diabetes mellitus (NIDDM) managed by diet. METHODS: Two hundred twelve obese subjects with NIDDM who had not received any diabetic medication for at least 12 weeks were randomized to receive acarbose or placebo. The subjects were stratified by fasting glucose level above or below 11.1 mmol/L (200 mg/dL). Based on the subject's therapeutic response and tolerance, the acarbose dosage was titrated from 50 to 300 mg three times per day. This 36-week study consisted of a 6-week pretreatment period, a 24-week double-blind treatment period, and a 6-week posttreatment period. RESULTS: Ninety-one subjects given acarbose and 98 subjects who received placebo were evaluable for efficacy. During a standard meal tolerance test at the double-blind end point, the differences between treatment groups in mean change from baseline were as follows: 0.9 mmol/L (16 mg/dL) for fasting plasma glucose level, approximately 2.8 mmol/L (50 mg/dL) for postprandial plasma glucose level, and 0.59% (P < .0001) for hemoglobin A1c concentration (for all three measurements, values decreased in the acarbose group and increased in the placebo group). CONCLUSIONS: Acarbose improved both fasting and postprandial hyperglycemia and improved overall glycemic control as measured by the hemoglobin A1c level. These findings suggest a beneficial role for acarbose in combination with diet in the treatment of obese subjects with NIDDM. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/7979840/Long_term_efficacy_and_safety_of_acarbose_in_the_treatment_of_obese_subjects_with_non_insulin_dependent_diabetes_mellitus_ DB - PRIME DP - Unbound Medicine ER -