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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Diamel
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Diamel | Dietary Supplement: Diamel<br>* 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.<br>|
| Placebo Comparator: B<br>Placebo | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Diamel, Dietary supplement