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

NCT01972724 | Completed Phase 4 Results

• 2 other identifiers: PG-9999-301-KRU1111-1145-8222
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 9

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.

Conditions

Type II Diabetes Mellitus

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 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.

  Baseline and Week 24

Secondary Outcomes (1)

• Change From Baseline in Fasting Plasma Glucose at Week 24

  Baseline and Week 24

Study Arms (3)

Pioglitazone 15 mg (Double-Blind)

EXPERIMENTAL

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.

Drug: Pioglitazone; Drug: Metformin; Drug: Sulfonylurea

Pioglitazone 30 mg (Double-Blind)

EXPERIMENTAL

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.

Drug: Pioglitazone; Drug: Metformin; Drug: Sulfonylurea

Pioglitazone 30 mg (Open-Label)

EXPERIMENTAL

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.

Drug: Pioglitazone; Drug: Metformin; Drug: Sulfonylurea

Interventions

Pioglitazone DRUG

Pioglitazone tablets

Also known as: ACTOS

Pioglitazone 15 mg (Double-Blind); Pioglitazone 30 mg (Double-Blind); Pioglitazone 30 mg (Open-Label)

Metformin DRUG

Metformin as prescribed in clinical practice

Pioglitazone 15 mg (Double-Blind); Pioglitazone 30 mg (Double-Blind); Pioglitazone 30 mg (Open-Label)

Sulfonylurea DRUG

Sulfonylurea as prescribed in clinical practice

Pioglitazone 15 mg (Double-Blind); Pioglitazone 30 mg (Double-Blind); Pioglitazone 30 mg (Open-Label)

Eligibility Criteria

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

You may qualify if:

• 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).
• Participants with a history of clinical diagnosis of established type 2 diabetes mellitus defined by the American Diabetes Association (ADA) criteria 2012.
• Male or female between 18 and 80 years of age.
• 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.
• Participants with glycosylated hemoglobin (HbA1c) ≥7.0% at the screening visit.
• Participants with C-peptide ≥1.0 ng/mL at the screening visit.
• 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.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from enrollment:
• Participants with type 1 diabetes mellitus or secondary forms of diabetes.
• Participants who have been treated with insulin for ≥7 days within 3 months prior to the screening visit.
• Participants with a history of bladder cancer or participants with active bladder cancer.
• Participants with a history of acute diabetic complications such as diabetic ketoacidosis.
• Participants with a history of acute or chronic metabolic acidosis, including diabetic ketoacidosis.
• Participants with unstable or rapidly progressive diabetic retinopathy, nephropathy (estimated glomerular filtration rate \[eGFR\] \<60mL/min/1.73m2).
• 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).
• Participants with cardiac failure or history of cardiac failure (New York Heart Association \[NYHA\] Stages 3 to 4).
• Participants with a serum alanine transaminase (ALT) level ≥2.5 times the upper limit of normal (ULN), active liver disease, or jaundice.
• Participants taking concomitant gemfibrozil or other strong cytochrome P450 (CYP)2C8 inhibitors.
• Participants with a history of recurrent or severe hypoglycemia.
• Participants with a history of any hemoglobinopathy (such as hemolytic anemias or sickle cell disease) that may affect determination of HbA1c.
• Participants with uninvestigated microscopic hematuria
• Participants with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, since the study drug contains lactose.

Sponsors & Collaborators

• Takeda: lead

Study Sites (9)

Unknown Facility

Chagwon, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Ulsan, South Korea

Location

Unknown Facility

Wŏnju, South Korea

Location

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone; Metformin; Sulfonylurea Compounds

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; Biguanides; Guanidines; Amidines; Urea; Amides; Sulfones

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 30, 2013
• Study Start: December 16, 2013
• Primary Completion: October 17, 2016
• Study Completion: October 17, 2016
• Last Updated: September 12, 2018
• Results First Posted: July 24, 2018

Record last verified: 2018-08

Locations

KR (9)