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

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ClinicalTrials.gov Identifier: NCT00994266
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : April 29, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Diamel Dietary Supplement: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy
Study Start Date : October 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
Diamel
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 Comparator: B
Placebo
Dietary Supplement: 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.




Primary Outcome Measures :
  1. Difference of insulin daily doses at week 24 and at the beginning of the study [ Time Frame: 24 weeks ]
  2. 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 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Occurrence of hypoglycemic episodes during treatment [ Time Frame: 24 weeks ]
  2. Difference of HbA1c concentrations at week 24 and at the beginning of the study [ Time Frame: 24 weeks ]
  3. Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994266


Locations
Cuba
Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital
Pinar del Río, Cuba, 20200
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Maria Elena de la Uz Herrera, MSC "Abel Santamaría Cuadrado" General Hospital
Study Director: Arturo Hernández Yero, PhD National Institute of Endocrinology

Responsible Party: Maria Elena de la Uz Herrera, "Abel Santamaría Cuadrado"General Hospital
ClinicalTrials.gov Identifier: NCT00994266     History of Changes
Other Study ID Numbers: CAT-0912-CU
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: April 2011

Keywords provided by Catalysis SL:
Type 2 diabetes
Diamel
Dietary supplement

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs