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

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Diamel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00994266

CAT-0912-CU

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Diamel

Treatment:

Dietary Supplement: Diamel

B

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo