Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00384215
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : January 11, 2011
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: insulin glargine [rDNA origin] injection Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin: a Randomized, Open, Parallel Study
Study Start Date : December 2001
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Compare occurrence of hypoglycemia
  2. Compare change in body weight
  3. Compare change in FPG
  4. Compare change in serum lipid profile
  5. Compare percentage of subjects achieving HbA1c levels </= 7%
  6. Compare the time until an HbA1c </= 7% is achieved
  7. Compare change in HRQOL
  8. Compare cost of therapy for hyperglycemia treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  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


  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00384215

Layout table for location information
United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Layout table for investigator information
Study Director: Karen Barch, B.S. Sanofi

Layout table for additonal information
Responsible Party: Study Director, sanofi-aventis Identifier: NCT00384215     History of Changes
Other Study ID Numbers: HOE901_4020
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs