Triple oral fixed-dose diabetes polypill versus insulin plus metformin efficacy demonstration study in the treatment of advanced type 2 diabetes

Diabetes, Obesity and Metabolism, 08/10/2011

Bell DSH et al. - When compared with suboptimally titrated IM there was a trend towards a lower haemoglobin A1c (HbA1c) with glimepiride, 500 mg sustained-release metformin, and 15 mg pioglitazone (GMP) and significantly more GMP subjects obtained an HbA1c under 7%. Global assessments by investigators and subjects showed both a greater efficacy and tolerability with GMP.

Methods

  • One hundred and one subjects were randomized to GMP or IM regimens for 12 weeks.
  • The primary outcome was the change in HbA1c and secondary outcomes were changes in fasting plasma, and postprandial plasma glucoses and the number of patients achieving a drop in HbA1c of over 1%.
  • Other secondary outcomes were changes in the lipid profile, C-peptide level, body weight as well as physician assessments of efficacy and patient assessment of tolerability.

Results

  • The primary outcome of a change in HbA1c showed a trend towards a lower HbA1c with GMP therapy (-1.33% vs. -0.83%; p = 0.059).
  • The number of subjects achieving a decrease in HbA1c of greater than 1.0% was significantly greater in the GMP therapy (72.5% vs. 22%; p = 0.0001).
  • Both regimens equally and significantly reduced fasting and postprandial glucose levels (p = 0.05).
  • Weight gain was nonsignificantly greater with IM (2.69 vs. 0.92 kg; p = 0.223).
  • Investigator assessment of efficacy was significantly better with GMP (p = 0.001) as was tolerability as assessed by patients (p = 0.0001).

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