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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasm Metastasis
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014