Double-blind, randomized, multicentre, and active comparator controlled investigation of the effect of Pioglitazone, Metformin, and the combination of both on cardiovascular risk in patients with type 2 diabetes receiving stable basal insulin therapy: the PIOCOMB study
2011

Effects of Pioglitazone and Metformin on Cardiovascular Risk in Type 2 Diabetes

Sample size: 121 publication 10 minutes Evidence: moderate

Author Information

Author(s): Markolf Hanefeld, Andreas Pfützner, Thomas Forst, Iris Kleine, Winfried Fuchs

Primary Institution: GWT-TUD mbH

Hypothesis

Does the addition of pioglitazone or metformin to basal insulin therapy affect cardiovascular risk markers in patients with type 2 diabetes?

Conclusion

Pioglitazone reduces inflammatory markers and improves insulin sensitivity in patients with type 2 diabetes on insulin therapy.

Supporting Evidence

  • Pioglitazone reduced MMP-9 levels significantly compared to metformin.
  • Insulin dosage was reduced in the pioglitazone group.
  • Adiponectin levels increased significantly in the pioglitazone and combination groups.
  • Reduction in hs-CRP was significant for pioglitazone and combination groups.
  • The combination of pioglitazone and metformin improved HbA1C more than either drug alone.

Takeaway

This study found that adding pioglitazone to insulin therapy helps lower certain harmful substances in the blood, making it better for heart health.

Methodology

This was a double-blind, randomized, multicentre trial involving 121 patients with type 2 diabetes who were treated with basal insulin and received either metformin, pioglitazone, or a combination for 6 months.

Potential Biases

Potential bias due to the involvement of pharmaceutical companies in the study.

Limitations

The study was limited to a specific age range and may not be generalizable to all patients with type 2 diabetes.

Participant Demographics

Participants were aged 30-75 years, predominantly male (61.1%), and all were Caucasian.

Statistical Information

P-Value

p = 0.0345

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1475-2840-10-65

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