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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994266
• Other study ID #: CAT-0912-CU
• 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

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

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