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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Diamel |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diamel | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Elena de la Uz Herrera, MSC | "Abel Santamaría Cuadrado" General Hospital | Principal Investigator |
| Arturo Hernández Yero, PhD | National Institute of Endocrinology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital | Pinar del Río | Provincia de Pinar del Río | 20200 | Cuba |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | 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. |
|
| 24 weeks |
| D004700 | Endocrine System Diseases |