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

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ClinicalTrials.gov Identifier: NCT00991055
Recruitment Status : Unknown
Verified October 2009 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : October 7, 2009
Last Update Posted : October 7, 2009
Sponsor:
Information provided by:
National Cheng-Kung University Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Pioglitazone Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. The change from baseline in HbA1Cand FPG [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Insulin resistance (HOMA-IR index) [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991055


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.         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Principal Investigator: Ta-Jen Wu, MD National Cheng Kung University College and Hospital

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT00991055     History of Changes
Other Study ID Numbers: HR-96-61
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs