Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Pioglitazone in Participants With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy (ADD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01972724
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : July 24, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE October 24, 2013
First Posted Date  ICMJE October 30, 2013
Results First Submitted Date  ICMJE October 3, 2017
Results First Posted Date  ICMJE July 24, 2018
Last Update Posted Date September 12, 2018
Actual Study Start Date  ICMJE December 16, 2013
Actual Primary Completion Date October 17, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
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. A negative change from baseline indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
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. A negative change from baseline indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Pioglitazone in Participants With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic control when used in participants with inadequately controlled type 2 diabetes mellitus treated with stable combinations of metformin and sulfonylurea.
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-center 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type II Diabetes Mellitus
Intervention  ICMJE
  • Drug: Pioglitazone
    Pioglitazone tablets
    Other Name: ACTOS
  • Drug: Metformin
    Metformin as prescribed in clinical practice
  • Drug: Sulfonylurea
    Sulfonylurea as prescribed in clinical practice
Study Arms  ICMJE
  • Experimental: Pioglitazone 15 mg (Double-Blind)
    Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
    Interventions:
    • Drug: Pioglitazone
    • Drug: Metformin
    • Drug: Sulfonylurea
  • Experimental: Pioglitazone 30 mg (Double-Blind)
    Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
    Interventions:
    • Drug: Pioglitazone
    • Drug: Metformin
    • Drug: Sulfonylurea
  • Experimental: Pioglitazone 30 mg (Open-Label)
    Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
    Interventions:
    • Drug: Pioglitazone
    • Drug: Metformin
    • Drug: Sulfonylurea
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2015)
114
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2013)
310
Actual Study Completion Date  ICMJE October 17, 2016
Actual Primary Completion Date October 17, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Participants 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 participant or legally authorized representative prior to any trial related procedure (including withdrawal of prohibited medication, if applicable).
  2. Participants with a history of clinical diagnosis of established type 2 diabetes mellitus defined by the American Diabetes Association (ADA) criteria 2012.
  3. Male or female between 18 and 80 years of age.
  4. Participants 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. Participants with glycosylated hemoglobin (HbA1c) ≥7.0% at the screening visit.
  6. Participants 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

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

  1. Participants with type 1 diabetes mellitus or secondary forms of diabetes.
  2. Participants who have been treated with insulin for ≥7 days within 3 months prior to the screening visit.
  3. Participants with a history of bladder cancer or participants with active bladder cancer.
  4. Participants with a history of acute diabetic complications such as diabetic ketoacidosis.
  5. Participants with a history of acute or chronic metabolic acidosis, including diabetic ketoacidosis.
  6. Participants with unstable or rapidly progressive diabetic retinopathy, nephropathy (estimated glomerular filtration rate [eGFR] <60mL/min/1.73m2).
  7. Participants 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. Participants with cardiac failure or history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4).
  9. Participants with a serum alanine transaminase (ALT) level ≥2.5 times the upper limit of normal (ULN), active liver disease, or jaundice.
  10. Participants taking concomitant gemfibrozil or other strong cytochrome P450 (CYP)2C8 inhibitors.
  11. Participants with a history of recurrent or severe hypoglycemia.
  12. Participants with a history of any hemoglobinopathy (such as hemolytic anemias or sickle cell disease) that may affect determination of HbA1c.
  13. Participants with uninvestigated microscopic hematuria
  14. Participants with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, since the study drug contains lactose.
  15. Participants with any other condition judged by the Investigator as unsuitable for the study.
  16. Participants 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 (IMP) or breastfeeding.
  18. Male participants planning to father during clinical trial conduct or within 3 months after the last planned dose of the IMP.
  19. Participants were previously enrolled into the current clinical trial.
  20. The participants 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. Participants 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 participants are anticipated not to be available for scheduled clinical trial visits/procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01972724
Other Study ID Numbers  ICMJE PG-9999-301-KR
U1111-1145-8222 ( Other Identifier: World Health Organization )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP