Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00384215
First received: October 4, 2006
Last updated: January 10, 2011
Last verified: January 2011

October 4, 2006
January 10, 2011
December 2001
Not Provided
To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.
Same as current
Complete list of historical versions of study NCT00384215 on ClinicalTrials.gov Archive Site
  • Compare occurrence of hypoglycemia
  • Compare change in body weight
  • Compare change in FPG
  • Compare change in serum lipid profile
  • Compare percentage of subjects achieving HbA1c levels </= 7%
  • Compare the time until an HbA1c </= 7% is achieved
  • Compare change in HRQOL
  • Compare cost of therapy for hyperglycemia treatment
Same as current
Not Provided
Not Provided
 
Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin
Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin: a Randomized, Open, Parallel Study

This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: insulin glargine [rDNA origin] injection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
352
February 2005
Not Provided

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

INCLUSION CRITERIA:

  1. Diagnosis of type 2 diabetes mellitus for at least six months
  2. Continuous treatment with at least 1g metformin or half maximally labeled dose of a SU daily for at least three months
  3. HbA1c >/= 8 % and </= 12%, inclusive, as measured at screening week
  4. Willingness to accept, and demonstrated ability to inject insulin glargine therapy
  5. Demonstrated ability and willingness to perform SMBG using a plasma-referenced glucose meter at least twice a day
  6. Ability to understand and willingness to adhere to and be compliant with the study protocol

EXCLUSION CRITERIA:

  1. Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months
  2. Congestive heart failure requiring pharmacological treatment
  3. Impaired renal function, as shown by but not limited to serum creatinine >/= 1.5 mg/dl (133µmol/L) for males, or >/= 1.4 mg/dl (124 µmol/L) for females
  4. Treatment with non-selective beta-blockers (including ocular)
  5. Acute infection
  6. History of or presence of signs of significant peripheral edema
  7. Acute or chronic or history of metabolic acidosis, including diabetic ketoacidosis
  8. Planned radiological examinations requiring administration of contrasting agents
  9. Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range
  10. History of hypoglycemia unawareness
  11. Pregnant or breastfeeding females
  12. Failure to use adequate contraception (women of current reproductive potential only)
  13. BMI < 25 kg/(m)(m)
  14. Treatment with systemic steroids or large doses of inhaled steroids
  15. Treatment with any diabetes medication other than the medications required by this study
  16. Use of an investigational drug within the previous month
  17. Known hypersensitivity to insulin glargine, pioglitazone or any of the components of insulin glargine and pioglitazone
  18. Any malignancy within the last five years, except adequately treated basal cell carcinoma and adequately treated cervical carcinoma in situ.
  19. Current addiction or alcohol abuse or history of substance or alcohol abuse within two years
  20. Diagnosis of dementia
  21. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study or interpretation of study results
  22. Inability to comply with study procedures
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00384215
HOE901_4020
Not Provided
Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Karen Barch, B.S. Sanofi
Sanofi
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP