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

NCT00991055 | Unknown Phase 4

• 1 other identifier: HR-96-61
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The change from baseline in HbA1Cand FPG

  Week 12

Secondary Outcomes (1)

• Insulin resistance (HOMA-IR index)

  Week 12

Study Arms (2)

Pioglitazone

EXPERIMENTAL

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Drug: Pioglitazone

Interventions

Pioglitazone 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)

Pioglitazone; Placebo

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ta-Jen Wu, MD

  National Cheng Kung University College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 7, 2009
• Study Start: May 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 7, 2009

Record last verified: 2009-10

Locations

TW (1)