Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Investigation of a Switch From Insulin Therapy to a Metformin & Saxagliptin Combination in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to investigate the success rate of a switch from insulin therapy to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus.
The following study is based on a previous clinical trial performed at ikfe GmbH in Mainz in
2006 and 2007 (PIOswitch). [2] The purpose of this trial was to demonstrate that type 2
diabetes patients treated with insulin can be effectively switched to a
pioglitazone/glimepiride combination without loss of glycemic control. The study was
performed with 100 patients, out of whom 76 were finally successfully switched, resulting in
a cheaper and more convenient therapy with indications of an improved laboratory
cardiovascular risk biomarker profile (Hohberg et al., Diabetes Obes. Metab. 11:464-471,
2009). [2] Glimeperide is an agent with unspecific stimulating effect on the ß-cell and is
considered to accelerate the progression of the disease while still controlling blood
glucose. In addition, it may cause hypoglycemia. The combination of pioglitazone with
glimepiride was selected, because pioglitazone requires approx. 5-6 weeks for developing its
full anti-diabetic efficacy and an immediate effect on glucose was required to avoid
glycemic deterioration.
It is tempting to speculate that the combination of a drug providing ß-cell protection (like
saxagliptin) with a drug effectively and rapidly lowering blood glucose through a different
mechanism of action (metformin) instead of unspecific ß-cell stimulation would result in an
even improved outcome without risk of hypoglycemia. The purpose of this study is to
investigate the success rate of a switch from insulin therapy to a metformin & saxagliptin
combination in patients with type 2 diabetes mellitus.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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