J Korean Med Sci.  2014 Jan;29(1):90-97. 10.3346/jkms.2014.29.1.90.

Comparison of Acarbose and Voglibose in Diabetes Patients Who Are Inadequately Controlled with Basal Insulin Treatment: Randomized, Parallel, Open-Label, Active-Controlled Study

Affiliations
  • 1Division of Endocrinology & Metabolism, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
  • 2Division of Endocrinology & Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. cdongs@kumc.or.kr
  • 3Division of Endocrinology & Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 4Division of Endocrinology & Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
  • 5Division of Endocrinology & Metabolism, Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea.
  • 6Division of Endocrinology & Metabolism, Department of Internal Medicine, Hallym University College of Medicine, Seoul, Korea.
  • 7Division of Endocrinology & Metabolism, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
  • 8Division of Endocrinology & Metabolism, Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea.
  • 9Division of Endocrinology & Metabolism, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
  • 10Division of Endocrinology & Metabolism, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
  • 11Division of Endocrinology & Metabolism, Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea.
  • 12Bayer Korea Ltd., Seoul, Korea.

Abstract

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% +/- 0.71% to 7.71% +/- 0.93%) and voglibose groups (from 8.38% +/- 0.73% to 7.68% +/- 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 +/- 69.38 to 176.80 +/- 46.63 mg/dL) compared with the voglibose group (from 224.18 +/- 70.07 to 193.01 +/- 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528)

Keyword

Diabetes Mellitus, Type 2; Acarbose; Voglibose

MeSH Terms

Acarbose/adverse effects/*therapeutic use
Blood Glucose
Diabetes Mellitus, Type 2/blood/*drug therapy
Enzyme Inhibitors/adverse effects/therapeutic use
Female
Hemoglobin A, Glycosylated/analysis
Humans
Hypoglycemic Agents/adverse effects/therapeutic use
Inositol/adverse effects/*analogs & derivatives/therapeutic use
Insulin/*blood/therapeutic use
Male
Metformin/therapeutic use
Middle Aged
Prospective Studies
alpha-Glucosidases/antagonists & inhibitors
Acarbose
Blood Glucose
Enzyme Inhibitors
Hemoglobin A, Glycosylated
Hypoglycemic Agents
Insulin
Inositol
Metformin
alpha-Glucosidases

Figure

  • Fig. 1 Fasting plasma glucose and mean glucose levels checked by 6 points during a day. (A) The mean fasting plasma glucose level at week 24 decreased by 16.27 ± 59.63 mg/dL in acarbose group and 10.44 ± 42.30 mg/dL in voglibose group. There were no statistically significant differences between the groups in changes in fasting glucose levels from baseline to week 24. (B) The glucose levels of 6 points at week 24 in acarbose group. (C) The glucose levels of 6 points at week 24 in voglibose group. The glucose levels of all time points significantly decreased compared with baseline within each acarbose and voglibose groups. Only those of 1 hr after dinner at week 24 significantly decreased in acarbose group compared with voglibose group. BB, before breakfast; AB, after breakfast; BL, before lunch; AL, after lunch; BD, before dinner; AD, after dinner. *P < 0.05; Change from baseline.


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