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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
116
Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks, in combination with the standard treatment consisting in two daily doses of insulin and proper diet.
Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks, in combination with the standard treatment consisting in two daily doses of insulin and proper diet.
Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital
Pinar del Río, Provincia de Pinar del Río, Cuba
Difference of insulin daily doses at week 24 and at the beginning of the study
Time frame: 24 weeks
Difference of glucose concentrations (fasting and post-prandial) at week 24 and at the beginning of the study considering the adjusted insulin doses during treatment
Time frame: 24 weeks
Occurrence of hypoglycemic episodes during treatment
Time frame: 24 weeks
Difference of HbA1c concentrations at week 24 and at the beginning of the study
Time frame: 24 weeks
Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study
Time frame: 24 weeks
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