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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Secondary Drug Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Pioglitazone

Group Type ACTIVE_COMPARATOR

pioglitazone

Intervention Type DRUG

tablet, 30 mg, once daily, 26 weeks

2

Insulin glargine

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type DRUG

subcutaneous injection, start dose 6-10 units, once daily, 26 weeks

Interventions

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pioglitazone

tablet, 30 mg, once daily, 26 weeks

Intervention Type DRUG

insulin glargine

subcutaneous injection, start dose 6-10 units, once daily, 26 weeks

Intervention Type DRUG

Other Intervention Names

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Actos Lantus

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role collaborator

Skane County Council Research & Development Foundation

UNKNOWN

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role lead

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

Site Status

Countries

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Sweden

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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