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

Study Overview
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Brief Summary
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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.

Official Title
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Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin: a Randomized, Open, Parallel Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin glargine [rDNA origin] injection


Participation Criteria
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Eligibility Criteria
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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: 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 EXCLUSION CRITERIA: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin glargine [rDNA origin] injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |