Clinical StudiesEfficacy of 24-Week Monotherapy With Acarbose, Metformin, or Placebo in Dietary-Treated NIDDM Patients: The Essen-II Study☆
Section snippets
Patients and Methods
The study was planned biometrically as a randomized three-arm (placebo, acarbose, metformin) group comparison that was double-blind with respect to acarbose/placebo treatment and single-blind with respect to metformin treatment. By choosing a single-blind design, a double-dummy design was avoided and patients’ treatment was kept close to everyday life.
The study was conducted in four internal practices in Essen, Germany. The randomization plan was generated by electronic data processing for 16
Actual Dosage and Duration of Treatment
All 3 test substances were dosed as planned, compliance was 98% (pill counting). The duration of treatment was 168.5 ± 8.1 days in the placebo group, 166.5 ± 11.1 days in the acarbose group, and 169.5 ± 2.7 days in the metformin group (means ± SD).
Efficacy
The courses of fasting and postprandial blood glucose are shown in Fig. 1. No change was observed during 24 weeks of placebo treatment, but a marked decrease could be seen for both fasting and postprandial BG with acarbose and metformin.
The baseline
Conclusions
Both acarbose and metformin are recommended for treatment of NIDDM as first-line single drugs when diet alone fails, as well as in combination with other antidiabetic drugs, by the European NIDDM Policy Group,[14]the Asian-Pacific NIDDM Policy Group,[15]and by the American Diabetes Association (ADA).[16]The results of this study demonstrate the beneficial effect of both drugs as first-line treatment on parameters of metabolic control in patients with NIDDM previously treated with diet alone.
Acknowledgements
We thank Drs. Uwe-Hans Day, Georg Garanin, and Eckard Lohr for collaboration in carrying out the study, Dipl Stat C. Norenberg for statistical evaluation, T. Borth for careful monitoring, M. Bungert, and M. Grünwald for editorial help.
References (46)
- et al.
Multicenter, placebo-controlled trial comparing acarbose (BAY g 5421) with placebo, tolbutamide, and tolbutamide-plus-acarbose in non-insulin-dependent diabetes mellitus
Am J Med.
(1995) - et al.
The impact of metformin therapy on hepatic glucose production and skeletal muscle glycogen synthase activity in overweight type II diabetic patients
Metabolism
(1993) - et al.
Relation of high-density lipoprotein cholesterol and triglycerides to incidence of atherosclerotic coronary artery disease (the PROCAM experience)
Am J Cardiol.
(1992) - et al.
Acarbose, a preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential
Drugs.
(1988) - et al.
Metabolic effects of metformin in non-insulin-dependent diabetes mellitus
NEJM.
(1995) - et al.
Therapeutic potentials of acarbose as first-line drug in NIDDM insufficiently treated with diet alone
Diabetes Care.
(1991) - et al.
Efficacy of 24-week monotherapy with acarbose, glibenclamide or placebo in NIDDM patients. The Essen Study
Diabetes Care.
(1994) - et al.
The efficacy of acarbose in the treatment of patients with non-insulin-dependent diabetes mellitus
Ann Intern Med.
(1994) - et al.
Reduction of glycosylated hemoglobin and postprandial hyperglycemia by acarbose in patients with NIDDM. A placebo-controlled dose-comparison study
Diabetes Care.
(1995) - et al.
Therapeutic comparison of metformin and sulfonylurea, alone and in various combinations. A double-blind controlled study
Diabetes Care.
(1994)
Efficacy of metformin in patients with non-insulin-dependent diabetes mellitus
NEJM.
The use of acarbose in the primary-care setting: evaluation of efficacy and tolerability of acarbose by postmarketing surveillance study
Clin Invest Med.
Comparison of acarbose and metformin treatment in non-insulin-dependent diabetic out-patients
A comparison of acarbose versus metformin as an adjuvant therapy in sulfonylurea-treated NIDDM patients
Diabetes Care.
Estimation of the concentration of low-density lipoprotein cholesterol in plasma without use of the preparative ultra centrifuge
Clin Chem.
A Desktop Guide for the Management of Non-insulin-dependent Diabetes Mellitus (NIDDM)
Non-insulin-dependent Diabetes Mellitus (NIDDM)
Practical Targets and Treatments
Consensus statement: The pharmacological treatment of hyperglycemia in NIDDM
Diabetes Care.
Metformin improves peripheral but not hepatic insulin action in obese patients with type II diabetes
Acta Endocrinol.
Metformin improves insulin sensitivity in insulin-resistant normoglycemic relatives of patients with non-insulin-dependent diabetes mellitus
Diabetes.
Effects of metformin on insulin resistance, risk factors for cardiovascular disease, and plasminogen activator inhibitor in NIDDM subjects
Diabetes Care.
Can we prevent the development of non-insulin-dependent diabetes mellitus?
Diabetes.
Hyperinsulinemia: the key feature of a cardiovascular and metabolic syndrome
Diabetologia.
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This work was supported by Bayer AG, Leverkusen, Germany.