Efficacy of Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Catalysis SL
- Enrollment
- 116
- Locations
- 2
- Primary Endpoint
- Difference of insulin daily doses at week 24 and at the beginning of the study
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Pregnancy.
- •HbA1c values greater than 10%.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Occurrence of hypoglycemic episodes during treatment(24 weeks)
- Difference of HbA1c concentrations at week 24 and at the beginning of the study(24 weeks)
- Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study(24 weeks)