Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin
NCT ID: NCT00384215
Last Updated: 2011-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
352 participants
INTERVENTIONAL
2001-12-31
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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insulin glargine [rDNA origin] injection
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
79 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Karen Barch, B.S.
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Bridgewater, New Jersey, United States
Countries
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Other Identifiers
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HOE901_4020
Identifier Type: -
Identifier Source: org_study_id
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