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CompletedNCT00358124Updated Jan 11, 2011

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

A Phase 4 interventional study of insulin glargine and rosiglitazone in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-01-11.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 220 is above the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants

Interventions

  • Druginsulin glargine
  • Drugrosiglitazone
  • Drugmetformin
06

What researchers measure

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

07

Study locations

1 site
  • Sanofi-Aventis
    Bridgewater, New Jersey 08807, United States
08

References and documents

Publications

  • Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G. Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care. 2006 Mar;29(3):554-9. doi: 10.2337/diacare.29.03.06.dc05-0695. PubMed 16505505 ↗
  • Vinik AI, Zhang Q. Adding insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diabetes Care. 2007 Apr;30(4):795-800. doi: 10.2337/dc06-1712. Epub 2007 Jan 26. Erratum In: Diabetes Care. 2007 Jun;30(6):1684. PubMed 17259481 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00358124
Lead sponsor
Sanofi
First posted
Jul 31, 2006
Start date
Jan 2001
Completion
Jun 2002
Last update
Jan 11, 2011

Study contacts

Karen Barch
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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