Comparison of the Efficacy and Safety Between Pioglitazone and Placebo Added to Combination Therapy in Type 2 Diabetes

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to study the efficacy and safety of pioglitazone added to combination therapy of sulfonylurea plus metformin with placebo in patients with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cheng-Kung University Hospital
• Treatments: Metformin; Pioglitazone

Criteria

Inclusion Criteria:

1. Male or Female, Aged > 25 years and had been diagnosed as type 2 diabetes for at least 3 months before study entry.

2. Subjects have taken sulfonylurea plus metformin therapy for at least 3 months before study entry.

3. Subjects have to take daily Metformin 500~2000mg tolerable dosages and sulfonylurea (such as the usage dose of glimepiride ≧4mg; dose of Gliclazide≧160mg; dose of Glipizide ≧20mg; dose of glyburide≧4mg) for at least 1 months.

4. Those subjects with HbA1C historical levels between 7.0% and 11.0% within 3 month prior to study entry.

5. BMI between 20-35 kg /m2.

6. Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document.

7. Subjects have been under stable diet control for at least 1 month before study entry.

8. Subjects are willing to stick to current diet and sulfonylurea plus metformin treatment plan during this trial.

Exclusion Criteria:

1. Pregnant women or lactating mothers.

2. Type 1 DM(IDDM), or diabetes caused by pancreas damage、secondary forms of diabetes, i.e., Cushing's syndrome or acromegaly.

3. A history of acute metabolic complication within 3 months before study entry, i.e., ketoacidosis or hyperosmolar state (coma).

4. There are significant macrovascular complications (i.e. unstable angina or acute myocardial infarction) or renal impairment (serum creatinine higher than 1.5 mg/dL).

5. Have a known allergy to pioglitazone.

6. Other medications can be taken if their use had been instituted before study entry, but agents that can interfere with study evaluations, including other oral antidiabetic agents and corticosteroids, were not allowed.