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Trial record 1 of 1 for:    PG-9999-301-KR
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Efficacy of Pioglitazone in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy (ADD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01972724
First received: October 24, 2013
Last updated: January 11, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic control as when used in patients with inadequately controlled type 2 diabetes mellitus treated with fixed combinations of metformin and sulfonylurea.

Condition Intervention Phase
Type II Diabetes Mellitus Drug: Pioglitazone Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 24-Week, Open Label, Phase IV Trial to Evaluate the Efficacy of Pioglitazone 30 mg in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy of Metformin, Sulfonylurea, and Pioglitazone 15 Mg (ADD Trial)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline and Week 24 ]
    The change from Baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24.


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose at Week 24 [ Time Frame: Baseline and Week 24 ]
    The change between the value of fasting serum glucose collected at Week 24 and fasting serum glucose collected at Baseline.


Enrollment: 114
Study Start Date: January 2014
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pioglitazone 30 mg
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea will be administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
Drug: Pioglitazone
Pioglitazone tablets
Other Name: ACTOS

Detailed Description:

The drug being tested in this study is called pioglitazone. Pioglitazone is being tested to treat glycemic control in adults with inadequately controlled type 2 diabetes mellitus. This study will look at glycemic control in people who take triple oral therapy of metformin, sulfonylurea, and pioglitazone 15 mg.

The study will enroll approximately 114 patients. All participants will be asked to take one pioglitazone tablet at the same time each day throughout the study as well as continuing their previous dose of metformin and sulfonylurea..

This multi-centre trial will be conducted in Korea. The overall time to participate in this study is up to 25 weeks. Participants will make 4 visits to the hospital or endocrinologist's office, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients meeting the following criteria will be considered for inclusion in the study:

  1. Institutional Review Board (IRB)-approved written informed consent form (ICF) must be obtained from the patient or legally authorized representative prior to any trial related procedure (including withdrawal of prohibited medication, if applicable)
  2. Patients with a history of clinical diagnosis of established type 2 diabetes mellitus defined by the ADA criteria 2012
  3. Male or female between 18 and 80 years of age
  4. Patients with stable triple oral therapy of metformin + sulfonylurea + pioglitazone (ACTOS) 15 mg or ACTOSMET(Pioglitazone 15mg/Metformin 850mg) and sulfonylurea for at least 12 weeks at the screening visit
  5. Patients with HbA1c ≥7.0% at the screening visit
  6. Patients with C-peptide ≥1.0 ng/mL at the screening visit
  7. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study, up to 30 days after the last dose of the study medication

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from enrollment:

  1. Patients with type 1 diabetes mellitus or secondary forms of diabetes
  2. Patients who have been treated with insulin for ≥7 days within 3 months prior to the screening visit
  3. Patients with a history of bladder cancer or patients with active bladder cancer
  4. Patients with a history of acute diabetic complications such as diabetic ketoacidosis
  5. Patients with a history of acute or chronic metabolic acidosis, including diabetic ketoacidosis
  6. Patients with unstable or rapidly progressive diabetic retinopathy, nephropathy (estimated glomerular filtration rate [eGFR] <60mL/min/1.73m2)
  7. Patients with cardiac insufficiency (e.g., a myocardial infarction, a coronary angioplasty or bypass graft, unstable angina, transient ischemic attacks, or a documented cerebrovascular accident within 6 months prior to the screening visit)
  8. Patients with cardiac failure or history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4)
  9. Patients with a serum alanine transaminase (ALT) level ≥2.5 times the upper limit of normal (ULN), active liver disease, or jaundice
  10. Patients taking concomitant gemfibrozil or other strong cytochrome P450 (CYP)2C8 inhibitors
  11. Patients with a history of recurrent or severe hypoglycemia
  12. Patients with a history of any hemoglobinopathy (such as hemolytic anemias or sickle cell disease) that may affect determination of HbA1c
  13. Patients with uninvestigated microscopic hematuria
  14. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, since the study drug contains lactose
  15. Patients with any other condition judged by the Investigator as unsuitable for the study
  16. Patients who have used any investigational or experimental drugs or devices within 60 days of the screening visit
  17. Lactating or pregnant female. A positive pregnancy test before the first administration of investigational medicinal product or breastfeeding
  18. Male patients planning to father during clinical trial conduct or within 3 months after the last planned dose of the IMP
  19. Patients were previously enrolled into the current clinical trial
  20. The patient participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic effect of the IMP of that clinical trial cannot be excluded
  21. Patients are considered unable or unwilling to co-operate adequately, i.e., to follow clinical trial procedures after Investigator has adequately instructed (e.g., language difficulties, etc.) or patients are anticipated not to be available for scheduled clinical trial visits/procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972724

Locations
Korea, Republic of
Chagwon, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Jeonju, Korea, Republic of
Seoul, Korea, Republic of
Ulsan, Korea, Republic of
Wonju, Korea, Republic of
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01972724     History of Changes
Other Study ID Numbers: PG-9999-301-KR
U1111-1145-8222 ( Other Identifier: World Health Organization )
Study First Received: October 24, 2013
Last Updated: January 11, 2017

Keywords provided by Takeda:
Drug therapy

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

ClinicalTrials.gov processed this record on June 26, 2017