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
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: insulin glargine [rDNA origin] injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 352
Study Start Date: December 2001
Estimated Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384215

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Karen Barch, B.S. Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00384215     History of Changes
Other Study ID Numbers: HOE901_4020
Study First Received: October 4, 2006
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014