Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes - Full Text View

Sponsor:	Skane University Hospital
Collaborators:	Medical Research Council Skane County Council Research & Development Foundation
Information provided by:	Skane University Hospital
ClinicalTrials.gov Identifier:	NCT00609856

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Secondary Drug Failure	Drug: pioglitazone Drug: insulin glargine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Pioglitazone Pioglitazone hydrochloride Insulin glargine

U.S. FDA Resources

Further study details as provided by Skane University Hospital:

Primary Outcome Measures:

Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of pioglitazone vs. insulin glargine on BNP [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	April 2004
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Pioglitazone	Drug: pioglitazone tablet, 30 mg, once daily, 26 weeks Other Name: Actos
Active Comparator: 2 Insulin glargine	Drug: insulin glargine subcutaneous injection, start dose 6-10 units, once daily, 26 weeks Other Name: Lantus

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.

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609856

Locations

Sweden
Malmö University Hospital
Malmö, Sweden, 20502

Sponsors and Collaborators

Skane University Hospital

Medical Research Council

Skane County Council Research & Development Foundation

Investigators

Study Director:

Leif Groop, Professor

Department of Clinical Sciences, Division of Diabetes & Endocrinology, Lund University, Malmö University Hospital, Sweden

More Information

No publications provided

Responsible Party:	Mozhgan Dorkhan/MD, Department of Clinical Sciences, Division of Diabetes & Endocrinology
ClinicalTrials.gov Identifier:	NCT00609856 History of Changes
Other Study ID Numbers:	Dnr 111/2004, 0
Study First Received:	January 24, 2008
Last Updated:	January 24, 2008
Health Authority:	Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone

Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012