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Therapeutic effect of benfluorex in type II diabetic patients on diet regimen alone
- Source :
- Journal of diabetes and its complications. 10(5)
- Publication Year :
- 1996
-
Abstract
- A randomized double-blind study of benfluorex (150 mg x 3 daily) versus placebo was conducted over 3 months in 32 type II diabetic patients (24 men and 8 women, aged 52 +/- 8.4 years) with mild stable obesity [body-mass index (BMI) 27 +/- 1.6 kg/ m2], moderate fasting hyperglycemia (fasting blood glucose 9 +/- 0.5 mmol/L, HbA1c 6.7 +/- 0.9%) and moderate hyperinsulinemia (18.6 +/- 3.0 microU/mL) when on treatment with diet alone. After a 1-month placebo run-in period, subjects were randomized to benfluorex or placebo three tablets daily. Inclusion parameters and end-of-study measures were body weight, BMI, fasting blood glucose, glycemic profile, HbA1c, fasting insulinemia, basal and stimulated C-peptide, and an insulin tolerance test (0.1 U/kg). The groups were homogeneous at baseline, except for glycemic profile (higher postprandial glycemia in the group randomized to benfluorex). At the end of the study, the groups did not differ in body weight or BMI; however, HbA1c decreased more with benfluorex (6.0 +/- 1.0% versus 6.8 +/- 0.9%, p = 0.024), as did the mean glycemic profile (7.8 +/- 1.4 versus 8.5 +/- 1.7 mmol/L, p0.001), including a particular decrease in postprandial glycemia. The decreases in fasting blood glucose and insulinemia appeared larger with benfluorex (7.7 +/- 1.3 versus 8.4 +/- 1.6 mmol/L and 13.5 +/- 4.5 versus 16.1 +/- 5.1 microU/mL, respectively), but were not statistically significant. The increase in the insulin sensitivity index (Kitt) was greater with benfluorex (+0.54 +/- 1.4 versus +0.25 +/- 1.3%/mn), but the difference was not statistically significant. The same was observed for the stimulated C-peptide. In type II diabetics with mild obesity and hyperglycemia previously managed with diet alone, benfluorex has significant long-term effect on HbA1c and mean daily blood glucose, and tends to lower insulinemia.
- Subjects :
- Adult
Blood Glucose
Male
medicine.medical_specialty
Time Factors
Endocrinology, Diabetes and Metabolism
Placebo
chemistry.chemical_compound
Endocrinology
Double-Blind Method
Diabetes mellitus
Internal medicine
Fenfluramine
Internal Medicine
Hyperinsulinemia
Medicine
Humans
Single-Blind Method
Glycemic
Hypolipidemic Agents
Benfluorex
Glycated Hemoglobin
business.industry
Insulin tolerance test
Body Weight
Middle Aged
medicine.disease
Postprandial Period
Postprandial
Basal (medicine)
chemistry
Diabetes Mellitus, Type 2
Female
business
Subjects
Details
- ISSN :
- 10568727
- Volume :
- 10
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Journal of diabetes and its complications
- Accession number :
- edsair.doi.dedup.....9fe12f70fef47dc86f8fe64874ac4905