Clinical trial NCT00384215: Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: Compare occurrence of hypoglycemia
measure: Compare change in body weight
measure: Compare change in FPG
measure: Compare change in serum lipid profile
measure: Compare percentage of subjects achieving HbA1c levels </= 7%
measure: Compare the time until an HbA1c </= 7% is achieved
measure: Compare change in HRQOL
measure: Compare cost of therapy for hyperglycemia treatment
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Karen Barch, B.S.
role: STUDY_DIRECTOR
References: