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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00994266
Other study ID # CAT-0912-CU
Secondary ID
Status Completed
Phase Phase 3
First received October 13, 2009
Last updated April 27, 2011
Start date October 2009
Est. completion date April 2011

Study information

Verified date April 2011
Source Catalysis SL
Contact n/a
Is FDA regulated No
Health authority Cuba: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 65 Years
Eligibility 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%.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Diamel
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.
Placebo
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.

Locations

Country Name City State
Cuba Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital Pinar del Río

Sponsors (1)

Lead Sponsor Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference of insulin daily doses at week 24 and at the beginning of the study 24 weeks No
Primary 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 24 weeks No
Secondary Occurrence of hypoglycemic episodes during treatment 24 weeks Yes
Secondary Difference of HbA1c concentrations at week 24 and at the beginning of the study 24 weeks No
Secondary Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study 24 weeks No
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