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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 3

Locations

Cuba

Study Type

Interventional

Intervention

Diamel

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Diamel, Dietary supplement

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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%.

Sites / Locations

Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Diamel

Placebo

Outcomes

Primary Outcome Measures

Difference of insulin daily doses at week 24 and at the beginning of the study

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

Secondary Outcome Measures

Occurrence of hypoglycemic episodes during treatment

Difference of HbA1c concentrations at week 24 and at the beginning of the study

Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study

Full Information

NCT ID

NCT00994266

First Posted

October 13, 2009

Last Updated

April 27, 2011

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT00994266

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Catalysis SL

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Type 2 diabetes, Diamel, Dietary supplement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Diamel

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Diamel

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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 Outcome Measure Information:

Title

Difference of insulin daily doses at week 24 and at the beginning of the study

Time Frame

24 weeks

Title

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 Outcome Measure Information:

Title

Occurrence of hypoglycemic episodes during treatment

Time Frame

24 weeks

Title

Difference of HbA1c concentrations at week 24 and at the beginning of the study

Time Frame

24 weeks

Title

Difference of triglycerides and cholesterol concentrations at week 24 and at the beginning of the study

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Elena de la Uz Herrera, MSC

Organizational Affiliation

"Abel Santamaría Cuadrado" General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arturo Hernández Yero, PhD

Organizational Affiliation

National Institute of Endocrinology

Official's Role

Study Director

Facility Information:

Facility Name

Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital

City

Pinar del Río

ZIP/Postal Code

20200

Country

Cuba

12. IPD Sharing Statement

Learn more about this trial

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

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