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
2 participants
INTERVENTIONAL
2007-03-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Pioglitazone
Pioglitazone 45 mg, 8 weeks
Pioglitazone
45 mg 8 weeks
Placebo
Placebo
Placebo
Placebo
Interventions
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Pioglitazone
45 mg 8 weeks
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)
* Casual blood pressure \> = 130/80 mmHg, \< 160/100 mmHg
Exclusion Criteria
* Combination therapy of sulfonyl-urea und metformin
* Therapy with nateglinid, repaglinid or an other substance of this drug family
* Allergy against pioglitazone or other composites of the tablet
* History of heart failure (NYHA I bis IV)
* Hepatic insufficiency
* Transaminases \> 2.5-fold of the upper normal limit
* End-stage renal failure
* Syndrome of polycystic ovaries
* Absence of effective contraception in women of childbearing potential
* Pregnancy or breast-feeding
18 Years
75 Years
MALE
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Roland E Schmieder, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Erlangen-Nürnberg, Medical Department 4
Locations
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CRC Medical Department IV
Erlangen, , Germany
Countries
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Other Identifiers
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2005-000570-52
Identifier Type: -
Identifier Source: org_study_id
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