Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy

Efficacy of Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy

The purpose of this study is to assess the efficacy of Diamel (dietary supplement) administration in the treatment of patients with type 2 diabetes receiving insulin therapy. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of patients to be recruited and randomized for the study is 116. Daily insulin requirements, blood glucose (fasting and post-prandial) concentrations, glycosylated hemoglobin (HbA1c), triglycerides and cholesterol will be assessed at the beginning and after 24 weeks of treatment.

Inclusion Criteria:

• Type 2 diabetes with insulin therapy regimen of two daily doses.
• Signed informed consent.

Exclusion Criteria:

• Type 1 diabetes.
• Type 2 diabetes with glibenclamide treatment.
• Nephropathy or liver condition diagnosed by clinical and/or biochemical examination.
• Sepsis.
• Pregnancy.
• HbA1c values greater than 10%.