Back to resultsPioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes, Secondary Drug Failure
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
pioglitazone
insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetes
- inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin
Exclusion Criteria:
- heart failure (NYHA II-IV)
Sites / Locations
- Malmö University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Pioglitazone
Insulin glargine
Outcomes
Primary Outcome Measures
Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity
Secondary Outcome Measures
Effect of pioglitazone vs. insulin glargine on BNP
Full Information
NCT ID
NCT00609856
First Posted
January 24, 2008
Last Updated
January 24, 2008
Sponsor
Skane University Hospital
Collaborators
Medical Research Council, Skane County Council Research & Development Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00609856
Brief Title
Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Official Title
Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Skane University Hospital
Collaborators
Medical Research Council, Skane County Council Research & Development Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.
Detailed Description
The present study was undertaken to assess differences in how insulin glargine vs. pioglitazone affect:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Secondary Drug Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Pioglitazone
Arm Title
2
Arm Type
Active Comparator
Arm Description
Insulin glargine
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
Actos
Intervention Description
tablet, 30 mg, once daily, 26 weeks
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Other Intervention Name(s)
Lantus
Intervention Description
subcutaneous injection, start dose 6-10 units, once daily, 26 weeks
Primary Outcome Measure Information:
Title
Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Effect of pioglitazone vs. insulin glargine on BNP
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 2 diabetes
inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin
Exclusion Criteria:
heart failure (NYHA II-IV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif Groop, Professor
Organizational Affiliation
Department of Clinical Sciences, Division of Diabetes & Endocrinology, Lund University, Malmö University Hospital, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Malmö University Hospital
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
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