Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
Skane County Council Research & Development Foundation
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00609856
First received: January 24, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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 4

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:


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 April 16, 2014