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Clinical Trials/NCT00994266
NCT00994266CompletedPhase 3

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

Catalysis SL2 sites in 1 country116 target enrollmentStarted: October 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
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)

Investigators

Sponsor Class
Industry

Study Sites (2)

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