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

C

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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