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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Diamel; Dietary Supplement: Placebo

• Registration Number: NCT00994266
• Lead Sponsor: Catalysis SL

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Status Verified: 2011-04
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Diamel	Diamel
B	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Difference of insulin daily doses at week 24 and at the beginning of the study	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	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital; 🇨🇺 Pinar del Río, Cuba