Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
NCT ID: NCT00609856
Last Updated: 2008-02-07
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
PHASE4
36 participants
INTERVENTIONAL
2004-04-30
2006-12-31
Brief Summary
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Detailed Description
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* Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test
* Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin resistance (HOMA-IR) and insulin tolerance test and
* Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma lipid profile as add-on therapy in patients with T2D and secondary drug failure. The patients' satisfaction with each treatment was also surveyed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Pioglitazone
pioglitazone
tablet, 30 mg, once daily, 26 weeks
2
Insulin glargine
insulin glargine
subcutaneous injection, start dose 6-10 units, once daily, 26 weeks
Interventions
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pioglitazone
tablet, 30 mg, once daily, 26 weeks
insulin glargine
subcutaneous injection, start dose 6-10 units, once daily, 26 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin
Exclusion Criteria
30 Years
75 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
Skane County Council Research & Development Foundation
UNKNOWN
Skane University Hospital
OTHER
Responsible Party
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Department of Clinical Sciences, Division of Diabetes & Endocrinology
Principal Investigators
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Leif Groop, Professor
Role: STUDY_DIRECTOR
Department of Clinical Sciences, Division of Diabetes & Endocrinology, Lund University, Malmö University Hospital, Sweden
Locations
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Malmö University Hospital
Malmo, , Sweden
Countries
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Other Identifiers
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0
Identifier Type: -
Identifier Source: secondary_id
Dnr 111/2004
Identifier Type: -
Identifier Source: org_study_id
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