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

NCT ID: NCT00991055

Last Updated: 2009-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-10-31

Brief 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.

Detailed Description

Pioglitazone hydrochloride, a thiazolidinedione compound, is a new therapeutic agent for the treatment of type 2 diabetes that reduces insulin resistance by enhancing insulin action in skeletal muscle, liver, and adipose tissue. In the study of diabetes, pioglitazone reduced the hyperglycemia, hyperinsulinemia, and hypertriglyceridemia characteristic of insulin-resistant states. The metabolic changes induced by pioglitazone result in increased responsiveness of insulin-dependent tissues and are observed in numerous models of insulin resistance.

In the present randomized, double-blind, parallel study, we aim to compare the efficacy and safety of pioglitazone added to combination therapy of sulfonylurea plus metformin with those of sulfonylurea plus metformin for the treatment of type 2 diabetic patients.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pioglitazone

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

A total 16-week randomized, double-blind, controlled study to compare the efficacy and safety of pioglitazone 15mg once daily added to combination metformin plus sulfonylurea with those of placebo combining control group.

(4-week run in period and 12-week pioglitazone 15mg added to combination therapy of sulfonylurea plus metformin and placebo control group in patients with type 2 diabetes)

Placebo

Group Type: PLACEBO_COMPARATOR

Pioglitazone

Intervention Type: DRUG

A total 16-week randomized, double-blind, controlled study to compare the efficacy and safety of pioglitazone 15mg once daily added to combination metformin plus sulfonylurea with those of placebo combining control group.

(4-week run in period and 12-week pioglitazone 15mg added to combination therapy of sulfonylurea plus metformin and placebo control group in patients with type 2 diabetes)

Interventions

Pioglitazone

A total 16-week randomized, double-blind, controlled study to compare the efficacy and safety of pioglitazone 15mg once daily added to combination metformin plus sulfonylurea with those of placebo combining control group.

(4-week run in period and 12-week pioglitazone 15mg added to combination therapy of sulfonylurea plus metformin and placebo control group in patients with type 2 diabetes)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Cheng-Kung University Hospital

Principal Investigators

Ta-Jen Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University College and Hospital

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Ta-Jen Wu, Dr

Role: primary

djwu@mail.ncku.edu.tw

886-6-2353535 ext. 5387

Other Identifiers

HR-96-61

Identifier Type: -

Identifier Source: org_study_id