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OpenTrials
Completed

NCT Number: NCT00358124

Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of type 2 diabetes mellitus for at least one year;
  • Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
  • Glycated hemoglobin between 7.5 and 11 % units, inclusive;
  • Willingness to accept, and ability to inject insulin glargine therapy

Exclusion criteria

  • Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
  • Congestive heart failure requiring pharmacological treatment;
  • Serum creatinine > 1.5 mg/dl for males, or > 1.4 mg/dl for females;
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
  • Planned radiological examinations requiring administration of contrasting agents;
  • Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
  • History of hypoglycemia unawareness;
  • Pregnancy or lactation;
  • Failure to use adequate contraception (women of current reproductive potential only);
  • Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
  • BMI >25 kg/m2;
  • Malignancy except basal cell carcinoma within the last five years;
  • History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse;
  • Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study;
  • Incapability to comply with study procedures

Treatment and study plan

insulin glargine

Drug

rosiglitazone

Drug

metformin

Drug

Primary outcomes

  1. The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.

  2. Other efficacy variables were the change from baseline in FPG, serum lipids and weight.

Secondary outcomes

  1. Secondary efficacy parameters were: a mean change from baseline in FPG

  2. Mean change from baseline in fasting insulin/C-peptide levels

  3. Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)

  4. Mean change from baseline for bodyweight.

  5. Health-related quality of life was compared between the baseline visit and the follow-up assessments

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Important dates

Study start
2001
Study completion
2002
First posted
Jul 31, 2006
Registry last updated
Jan 11, 2011

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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