NCT00994266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 29, 2011

Status Verified

April 1, 2011

Enrollment Period

1.5 years

First QC Date

October 13, 2009

Last Update Submit

April 27, 2011

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesDiamelDietary supplement

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

A

EXPERIMENTAL

Diamel

Dietary Supplement: Diamel

B

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

DiamelDIETARY_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.

A
PlaceboDIETARY_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.

B

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes with insulin therapy regimen of two daily doses.
  • Signed informed consent.

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Maria Elena de la Uz Herrera, MSC

    "Abel Santamaría Cuadrado" General Hospital

    PRINCIPAL INVESTIGATOR

  • Arturo Hernández Yero, PhD

    National Institute of Endocrinology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 29, 2011

Record last verified: 2011-04

Locations

CU(1)