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NCT Number: NCT00994266

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

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital

Pinar del Río, Provincia de Pinar del Río, 20200, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2009
Registry last updated
Apr 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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