ALPHA-GLUCOSIDASE INHIBITORS













  • Average baseline A1C not reported
  • Length of studies not reported
  • Reference [1]
Acarbose (Aca) monotherapy in placebo-controlled trials in type two diabetics
Aca 25 mg 3 times a day
(N=110)		 Aca 50 mg 3 times a day
(N=131)		 Aca 100 mg 3 times a day
(N=244)
HgA1C (%)
(placebo-subtracted change)		 -0.44% -0.77% -0.74%

  • N=147 | Average baseline A1C ∼ 8.3% | Metformin dose ≥ 2000 mg/day
  • Average baseline 1 hr PP blood sugar ∼ 269mg/dl
  • Reference [1]
Acarbose (Aca) added to metformin in a 6 month trial
Placebo + metformin Aca 50 - 100 mg 3 times a day + metformin
HgA1C (%)
(average change from baseline)		 +0.08% -0.57%
1 hour postprandial blood sugar
(average change from baseline)		 +3.3 mg/dl -31 mg/dl

  • Average baseline A1C and number of subjects not provided
  • Reference [2]
Miglitol (Mig) monotherapy for 14 weeks
Placebo
 Mig 50 mg 3 times a day Mig 100 mg 3 times a day
HgA1C (%)
(average change from baseline)		 +0.47% -0.22% -0.28%
1 hour postprandial blood sugar
(average change from baseline)		 +15 mg/dl -52 mg/dl -59 mg/dl








STOP-NIDDM - Acarbose vs Placebo for the Prevention of T2DM, Lancet (2002) [PubMed abstract]
  • The STOP-NIDDM trial enrolled 1429 prediabetics
Main inclusion criteria
  • Age 40 - 70 years
  • BMI 25 - 40
  • OGTT of 140 - 200 mg/dl and FBS of 100 - 139 mg/dl
Baseline characteristics
  • Average age 54 years
  • Average weight - 191 lbs (87 kg)
  • Average BMI - 31
  • Average fasting glucose - 112 mg/dl
  • Average 2-hour GTT - 167 mg/dl
Randomized treatment groups
  • Group 1 (682 patients) - Acarbose with a target dose of 100 mg three times a day (mean dose achieved 194 mg/day)
  • Group 2 (686 patients) - Placebo three times a day
  • All patients were counseled on weight loss and encouraged to exercise
Primary outcome: Development of diabetes based on a 2-hour OGTT of > 200 mg/dl
Results

Duration: Average of 3.3 years
Outcome Acarbose Placebo Comparisons
Primary outcome (percent with diabetes) 32% 42% HR 0.75, 95%CI [0.63 - 0.90], p=0.0015
Flatulence 68% 27% N/A
Diarrhea 32% 17% N/A
Abdominal pain 17% 12% N/A
Dropout rate 31% 19% N/A
  • At the conclusion of the trial, all patients who had not developed diabetes were given placebo for 3 months, after which a glucose tolerance test was repeated. In the acarbose group, 15% of patients converted to diabetes compared to 10% in the placebo group.

Findings: Acarbose could be used, either as an alternative or in addition to changes in lifestyle, to delay development of type 2 diabetes in patients with impaired glucose tolerance




Reference [1,2,7,9]
GI side effect Frequency (% of patients)
Flatulence 40 - 70%
Diarrhea 30%
Abdominal pain 10 - 20%