BACKGROUND AND OBJECTIVE: Multiple oral therapies are required long term for the majority of patients with type 2 diabetes mellitus to achieve acceptable glycaemic levels; alternatively, insulin therapy has to be initiated. This study investigated the addition of acarbose to maximum doses of sulfonylurea in very poorly controlled type 2 diabetes patients and assessed its effect in delaying further glycaemic deterioration. STUDY DESIGN: In this 78-week, double-blind, placebo-controlled European study, patients were randomised to receive acarbose, titrated to a maximum dose of 100mg three times daily, or matching placebo. Concomitant sulfonylurea treatment (glibenclamide/gliclazide) was to remain unchanged throughout the study. A sample size of 171 patients per treatment arm was calculated. The primary efficacy analysis was intention to treat. METHODS: The change in glycosylated haemoglobin (HbA(1c)) levels from baseline to the end of the study was regarded as the primary efficacy variable. Patients whose HbA(1c) levels increased above 10.5% on two consecutive visits terminated the study prematurely because of insulin administration. Secondary efficacy variables included the changes in blood glucose and C-peptide, both at fasting and at the 1h-postprandial level. PATIENTS: A total of 330 patients (acarbose 164, placebo 166) were valid for the efficacy analysis. Patients were generally overweight (body mass index 29.0 kg/m(2)) and showed very poor metabolic control (HbA(1c) >9%, fasting blood glucose >200 mg/dL, and 1h-postprandial blood glucose >300 mg/dL). RESULTS:Acarbose significantly improved HbA(1c) levels compared with placebo (least square mean [LS-mean] difference -0.54%, 95% CI -0.86 to -0.22; p = 0.001). A number of patients had to discontinue the study prematurely because of insulin administration (24.5% in the placebo and 14.2% in the acarbose group). There was a significant LS-mean difference of -14.8 mg/dL (p = 0.0195) in fasting blood glucose levels and highly significant differences in 1h-postprandial blood glucose (LS-mean difference -33.4 mg/dL, p < 0.0001) and in the rise in blood glucose from fasting to 1h-postprandial (LS-mean difference -19.6 mg/dL, p = 0.0001), all in favour of acarbose. Acarbose was shown to have a good safety profile and was generally well tolerated. CONCLUSION:Acarbose was shown to have the potential to delay further deterioration of glucose control in type 2 diabetes patients who are very poorly controlled with maximum sulfonylurea doses.
RCT Entities:
BACKGROUND AND OBJECTIVE: Multiple oral therapies are required long term for the majority of patients with type 2 diabetes mellitus to achieve acceptable glycaemic levels; alternatively, insulin therapy has to be initiated. This study investigated the addition of acarbose to maximum doses of sulfonylurea in very poorly controlled type 2 diabetespatients and assessed its effect in delaying further glycaemic deterioration. STUDY DESIGN: In this 78-week, double-blind, placebo-controlled European study, patients were randomised to receive acarbose, titrated to a maximum dose of 100mg three times daily, or matching placebo. Concomitant sulfonylurea treatment (glibenclamide/gliclazide) was to remain unchanged throughout the study. A sample size of 171 patients per treatment arm was calculated. The primary efficacy analysis was intention to treat. METHODS: The change in glycosylated haemoglobin (HbA(1c)) levels from baseline to the end of the study was regarded as the primary efficacy variable. Patients whose HbA(1c) levels increased above 10.5% on two consecutive visits terminated the study prematurely because of insulin administration. Secondary efficacy variables included the changes in blood glucose and C-peptide, both at fasting and at the 1h-postprandial level. PATIENTS: A total of 330 patients (acarbose 164, placebo 166) were valid for the efficacy analysis. Patients were generally overweight (body mass index 29.0 kg/m(2)) and showed very poor metabolic control (HbA(1c) >9%, fasting blood glucose >200 mg/dL, and 1h-postprandial blood glucose >300 mg/dL). RESULTS:Acarbose significantly improved HbA(1c) levels compared with placebo (least square mean [LS-mean] difference -0.54%, 95% CI -0.86 to -0.22; p = 0.001). A number of patients had to discontinue the study prematurely because of insulin administration (24.5% in the placebo and 14.2% in the acarbose group). There was a significant LS-mean difference of -14.8 mg/dL (p = 0.0195) in fasting blood glucose levels and highly significant differences in 1h-postprandial blood glucose (LS-mean difference -33.4 mg/dL, p < 0.0001) and in the rise in blood glucose from fasting to 1h-postprandial (LS-mean difference -19.6 mg/dL, p = 0.0001), all in favour of acarbose. Acarbose was shown to have a good safety profile and was generally well tolerated. CONCLUSION:Acarbose was shown to have the potential to delay further deterioration of glucose control in type 2 diabetespatients who are very poorly controlled with maximum sulfonylurea doses.
Authors: M Hanefeld; S Fischer; U Julius; J Schulze; U Schwanebeck; H Schmechel; H J Ziegelasch; J Lindner Journal: Diabetologia Date: 1996-12 Impact factor: 10.122
Authors: J L Chiasson; R G Josse; J A Hunt; C Palmason; N W Rodger; S A Ross; E A Ryan; M H Tan; T M Wolever Journal: Ann Intern Med Date: 1994-12-15 Impact factor: 25.391
Authors: David C Klonoff; Lawrence Blonde; George Cembrowski; Antonio Roberto Chacra; Guillaume Charpentier; Stephen Colagiuri; George Dailey; Robert A Gabbay; Lutz Heinemann; David Kerr; Antonio Nicolucci; William Polonsky; Oliver Schnell; Robert Vigersky; Jean-François Yale Journal: J Diabetes Sci Technol Date: 2011-11-01
Authors: Kees J Gorter; Floris Alexander van de Laar; Paul G H Janssen; Sebastian T Houweling; Guy E H M Rutten Journal: BMJ Clin Evid Date: 2012-10-11