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

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00384215

Run by

Sanofi

People needed

352

Starts

2001-12-01

Expected to finish

2005-02-01

Last updated by the study team

2011-01-11

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 2 diabetes mellitus for at least six months
• Continuous treatment with at least 1g metformin or half maximally labeled dose of a SU daily for at least three months
• HbA1c >/= 8 % and </= 12%, inclusive, as measured at screening week
• Willingness to accept, and demonstrated ability to inject insulin glargine therapy
• Demonstrated ability and willingness to perform SMBG using a plasma-referenced glucose meter at least twice a day
• Ability to understand and willingness to adhere to and be compliant with the study protocol

You may not qualify if…

• Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months
• Congestive heart failure requiring pharmacological treatment
• 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
• Treatment with non-selective beta-blockers (including ocular)
• Acute infection
• History of or presence of signs of significant peripheral edema
• Acute or chronic or history of metabolic acidosis, including diabetic ketoacidosis
• Planned radiological examinations requiring administration of contrasting agents
• Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range
• History of hypoglycemia unawareness
• Pregnant or breastfeeding females
• Failure to use adequate contraception (women of current reproductive potential only)
• BMI < 25 kg/(m)(m)
• Treatment with systemic steroids or large doses of inhaled steroids
• Treatment with any diabetes medication other than the medications required by this study
• Use of an investigational drug within the previous month
• Known hypersensitivity to insulin glargine, pioglitazone or any of the components of insulin glargine and pioglitazone
• Any malignancy within the last five years, except adequately treated basal cell carcinoma and adequately treated cervical carcinoma in situ.
• Current addiction or alcohol abuse or history of substance or alcohol abuse within two years
• Diagnosis of dementia
• 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
• Inability to comply with study procedures

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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