Diabetes Mellitus Clinical Trial
Official title:
Effects of Pioglitazone in Combination With Glimepiride in Comparison to Glimepiride Monotherapy on Metabolic Control in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and glimepiride combination therapy compared to glimepiride monotherapy in subjects with Type 2 Diabetes.
Tight glycemic control is mandatory for the prevention and treatment of vascular
complications in patients suffering from diabetes mellitus. After onset of Type 2 Diabetes,
patients are usually treated with diet along with or without different combinations of oral
drugs. One first-line drug class are sulfonylurea drugs that are preferably provided to
patients who are not obese. The mode of action of sulfonylurea drugs is to increase
beta-cell secretion, but it could be shown that they lead to deterioration of the beta-cell
secretion product over time, resulting in increased proinsulin secretion. Since proinsulin
is an independent cardiovascular risk factor, recent publications have demonstrated an
increased risk for cardiovascular events in patients treated with sulfonylurea drugs as
compared to other treatment methods.
Combination therapy of sulfonylurea drugs with glitazones has been shown to counterbalance
the effect of deteriorated beta-cell secretion and to improve insulin sensitivity and the
levels of proinsulin, C-peptide and other laboratory surrogate markers for cardiovascular
risk. Proving that the treatment of diabetic patients with higher doses of beta cytotropic
agents can be avoided and beta-cell function can be preserved by using pioglitazone in
combination with low dose sulfonylurea drugs, it will be possible to optimize the treatment
of patients with type 2 diabetes who are not controlled efficiently by sulfonylurea drugs
monotherapy.
In this study patients will be enrolled who are inefficiently treated with a Glimepiride
monotherapy. Patients will be either randomized to a combinational therapy of Pioglitazone
and Glimepiride or Glimepiride monotherapy. If possible, study medication will be
up-titrated to maximal dosage levels in both treatment arms to observe maximal and
comparable treatment effects. Stable effects on beta-cell function will be observed after 24
weeks of treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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