NCT00358124

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

First QC Date

July 28, 2006

Last Update Submit

January 10, 2011

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

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

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

Secondary Outcomes (5)

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

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

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

  • Mean change from baseline for bodyweight.

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

Interventions

insulin glargineDRUG
rosiglitazoneDRUG
metforminDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Related Publications (2)

  • 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.

    PMID: 16505505BACKGROUND

  • 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.

    PMID: 17259481BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin GlargineRosiglitazoneMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Karen Barch

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 28, 2006

First Posted

July 31, 2006

Study Start

January 1, 2001

Study Completion

June 1, 2002

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

US(1)