Diamel in the Treatment of Type 2 Diabetic Patients Receiving Insulin Therapy
NCT ID: NCT00994266
Last Updated: 2011-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2009-10-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Diamel
Diamel
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.
B
Placebo
Placebo
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.
Interventions
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Diamel
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.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent.
Exclusion Criteria
* Type 2 diabetes with glibenclamide treatment.
* Nephropathy or liver condition diagnosed by clinical and/or biochemical examination.
* Sepsis.
* Pregnancy.
* HbA1c values greater than 10%.
40 Years
65 Years
ALL
No
Sponsors
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Catalysis SL
INDUSTRY
Responsible Party
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"Abel Santamaría Cuadrado"General Hospital
Principal Investigators
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Maria Elena de la Uz Herrera, MSC
Role: PRINCIPAL_INVESTIGATOR
"Abel Santamaría Cuadrado" General Hospital
Arturo Hernández Yero, PhD
Role: STUDY_DIRECTOR
National Institute of Endocrinology
Locations
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Diabetes Care Center. "Abel Santamaría Cuadrado" General Hospital
Pinar del Río, Provincia de Pinar del Río, Cuba
Countries
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Other Identifiers
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CAT-0912-CU
Identifier Type: -
Identifier Source: org_study_id