Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

NCT00286494 | Completed Phase 3 Results

• 3 other identifiers: SYR-322-TZD-0092005-004669-40U1111-1113-8552
• Study Type: interventional
• Target: 493
• Locations: 14 countries
• Sites: 77

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

  The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.

  Baseline and Week 26.

Secondary Outcomes (50)

• Change From Baseline in Glycosylated Hemoglobin (Week 4).

  Baseline and Week 4.

• Change From Baseline in Glycosylated Hemoglobin (Week 8).

  Baseline and Week 8.

• Change From Baseline in Glycosylated Hemoglobin (Week 12).

  Baseline and Week 12.

• Change From Baseline in Glycosylated Hemoglobin (Week 16).

  Baseline and Week 16.

• Change From Baseline in Glycosylated Hemoglobin (Week 20).

  Baseline and Week 20.

Study Arms (3)

Placebo

ACTIVE COMPARATOR

Drug: Pioglitazone

Alogliptin 12.5 mg QD

EXPERIMENTAL

Drug: Alogliptin and pioglitazone

Alogliptin 25 mg QD

EXPERIMENTAL

Drug: Alogliptin and pioglitazone

Interventions

Alogliptin and pioglitazone DRUG

Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks

Also known as: SYR110322, Alogliptin, AD-4833, Pioglitazone, Actos, SYR-322

Alogliptin 12.5 mg QD

Pioglitazone DRUG

Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks

Also known as: AD-4833, Actos

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 2 diabetes mellitus currently treated with a thiazolidinedione either alone or in combination with metformin or a sulfonylurea but who are experiencing inadequate glycemic control. The subject should have received the thiazolidinedione therapy (rosiglitazone or pioglitazone) either alone or in combination with metformin or a sulfonylurea for at least the 3 months prior to Screening and must have been on a stable dose for all their antidiabetic treatments for at least the month prior to Screening.
• No treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
• Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
• Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.)
• Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.
• If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
• Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg.
• Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to10 g per dL for females.
• Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
• Serum creatinine less than or equal to 2.0 mg per dL.
• Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
• Neither pregnant nor lactating.
• Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study.
• Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
• No major illness or debility that in the investigator's opinion prohibits the subject from completing the study.

You may not qualify if:

• Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.
• History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)
• History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
• History of treated diabetic gastric paresis.
• New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
• History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening
• History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
• History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• History of a psychiatric disorder that will affect the subject's ability to participate in the study.
• History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
• History of alcohol or substance abuse within the 2 years prior to Screening.
• Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.
• Prior treatment in an investigational study of alogliptin.
• Excluded Medications:
• Treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures.

Sponsors & Collaborators

• Takeda: lead

Study Sites (77)

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Artesia, California, United States

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Fresno, California, United States

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Mission Viejo, California, United States

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Northridge, California, United States

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Orange, California, United States

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San Diego, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Norwalk, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Clearwater, Florida, United States

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Cocoa Beach, Florida, United States

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Hollywood, Florida, United States

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Kissimmee, Florida, United States

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Longwood, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Ocoee, Florida, United States

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Saint Cloud, Florida, United States

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Tampa, Florida, United States

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Lawrenceville, Georgia, United States

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Honolulu, Hawaii, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Lafayette, Indiana, United States

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Erlanger, Kentucky, United States

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Baltimore, Maryland, United States

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Sudbury, Massachusetts, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Berlin, New Jersey, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Morehead City, North Carolina, United States

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Pinehurst, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Lansdale, Pennsylvania, United States

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West Grove, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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Cookeville, Tennessee, United States

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Milan, Tennessee, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Texarkana, Texas, United States

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Burlington, Vermont, United States

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Multiple Cities, Argentina

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Multiple Cities, Australia

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Multiple Cities, Brazil

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Multiple Cities, Czechia

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Multiple Cities, Germany

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Multiple Cities, Guatemala

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Multiple Cities, Hungary

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Multiple Cities, India

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Multiple Cities, Mexico

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Multiple Cities, Netherlands

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Multiple Cities, New Zealand

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Multiple Cities, Peru

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Multiple Cities, South Africa

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Related Publications (2)

• Pratley RE, Reusch JE, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 009 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2009 Oct;25(10):2361-71. doi: 10.1185/03007990903156111.

  PMID: 19650752 RESULT

• Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.

  PMID: 19793357 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

alogliptin; Pioglitazone

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• VP Biological Sciences

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: February 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: February 3, 2012
• Results First Posted: September 27, 2011

Record last verified: 2012-02

Locations

PE (1); ZA (1); BR (1); ME (1); GU (1); AR (1); DE (1); CZ (1); AU (1); HU (1); IN (1); US (64); NL (1); NZ (1)