Comparison of the Efficacy and Safety Between Pioglitazone and Placebo Added to Combination Therapy in Type 2 Diabetes
To Compare the Efficacy and Safety Between Pioglitazone Added to Combination Therapy of Sulfonylurea Plus Metformin and Placebo Control Group in Patients With Type 2 Diabetes
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Tainan, Taiwan
- Recruiting
- National Cheng Kung University Hospital
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Contact:
- Ta-Jen Wu, Dr
- Phone Number: 5387 886-6-2353535
- Email: djwu@mail.ncku.edu.tw
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Principal Investigator:
- Ta-Jen Wu, Dr.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or Female, Aged > 25 years and had been diagnosed as type 2 diabetes for at least 3 months before study entry.
- Subjects have taken sulfonylurea plus metformin therapy for at least 3 months before study entry.
- 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.
- Those subjects with HbA1C historical levels between 7.0% and 11.0% within 3 month prior to study entry.
- BMI between 20-35 kg /m2.
- 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.
- Subjects have been under stable diet control for at least 1 month before study entry.
- Subjects are willing to stick to current diet and sulfonylurea plus metformin treatment plan during this trial.
Exclusion Criteria:
- Pregnant women or lactating mothers.
- Type 1 DM(IDDM), or diabetes caused by pancreas damage、secondary forms of diabetes, i.e., Cushing's syndrome or acromegaly.
- A history of acute metabolic complication within 3 months before study entry, i.e., ketoacidosis or hyperosmolar state (coma).
- There are significant macrovascular complications (i.e. unstable angina or acute myocardial infarction) or renal impairment (serum creatinine higher than 1.5 mg/dL).
- Have a known allergy to pioglitazone.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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PLACEBO_COMPARATOR: Placebo
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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) |
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EXPERIMENTAL: Pioglitazone
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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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The change from baseline in HbA1Cand FPG
Time Frame: Week 12
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Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Insulin resistance (HOMA-IR index)
Time Frame: Week 12
|
Week 12
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ta-Jen Wu, MD, National Cheng Kung University College and Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-96-61
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