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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994266

Enrollment

116

Registered

2009-10-14

Start date

2009-10-31

Completion date

2011-04-30

Last updated

2011-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes, Diamel, Dietary supplement

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTDiamel

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.

DIETARY_SUPPLEMENTPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

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%.

Design outcomes

Primary

Measure	Time frame
Difference of insulin daily doses at week 24 and at the beginning of the study	24 weeks
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	24 weeks

Secondary

Measure	Time frame
Occurrence of hypoglycemic episodes during treatment	24 weeks
Difference of HbA1c concentrations at week 24 and at the beginning of the study	24 weeks
Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study	24 weeks

Countries

Cuba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026