Comparison of the Efficacy and Safety Between Pioglitazone and Placebo Added to Combination Therapy in Type 2 Diabetes
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Pioglitazone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
- The change from baseline in HbA1Cand FPG [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Insulin resistance (HOMA-IR index) [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pioglitazone |
Drug: 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) |
| Placebo Comparator: Placebo |
Drug: 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) |
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.
Eligibility| Ages Eligible for Study: | 25 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Taiwan | |
| National Cheng Kung University Hospital | Recruiting |
| Tainan, Taiwan | |
| Contact: Ta-Jen Wu, Dr 886-6-2353535 ext 5387 djwu@mail.ncku.edu.tw | |
| Principal Investigator: Ta-Jen Wu, Dr. | |
| Principal Investigator: | Ta-Jen Wu, MD | National Cheng Kung University College and Hospital |
More Information
No publications provided
| Responsible Party: | National Cheng-Kung University Hospital |
| ClinicalTrials.gov Identifier: | NCT00991055 History of Changes |
| Other Study ID Numbers: | HR-96-61 |
| Study First Received: | October 1, 2009 |
| Last Updated: | October 6, 2009 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013