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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014