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NCT Number: NCT00609856

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Secondary Drug Failure

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Malmö University Hospital

Malmö, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

pioglitazone

Drug

tablet, 30 mg, once daily, 26 weeks

Other names: Actos

insulin glargine

Drug

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

Other names: Lantus

Primary outcomes

  1. Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity

    Time frame: 26 weeks

Secondary outcomes

  1. Effect of pioglitazone vs. insulin glargine on BNP

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Medical Research Council
  • Skane County Council Research & Development Foundation

Registry information

Official study title

Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 7, 2008
Registry last updated
Feb 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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