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

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00994266
First received: October 13, 2009
Last updated: April 27, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Type 2 Diabetes
Dietary Supplement: Diamel
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Difference of insulin daily doses at week 24 and at the beginning of the study [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of hypoglycemic episodes during treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Difference of HbA1c concentrations at week 24 and at the beginning of the study [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: October 13, 2009
Last Updated: April 27, 2011
Health Authority: Cuba: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014