Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGinsulin glargine [rDNA origin] injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Compare the time until an HbA1c </= 7% is achieved | — |
| Compare change in HRQOL | — |
| Compare cost of therapy for hyperglycemia treatment | — |
| Compare percentage of subjects achieving HbA1c levels </= 7% | — |
| Compare change in body weight | — |
| Compare change in FPG | — |
| Compare change in serum lipid profile | — |
| Compare occurrence of hypoglycemia | — |
Countries
United States
Outcome results
None listed