Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes

NCT00286455 | Completed Phase 3 Results

• 3 other identifiers: SYR-322-PLC-0102005-004670-24U1111-1113-8462
• Study Type: interventional
• Target: 329
• Locations: 18 countries
• Sites: 67

Brief Summary

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

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 (56)

• 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)

Alogliptin 12.5 mg QD

EXPERIMENTAL

Drug: Alogliptin

Alogliptin 25 mg QD

EXPERIMENTAL

Drug: Alogliptin

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Alogliptin DRUG

Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.

Also known as: SYR110322, SYR-322

Alogliptin 12.5 mg QD

Placebo DRUG

Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.

Placebo QD

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes mellitus, experiencing inadequate glycemic control, and are receiving no current antidiabetic therapy. Subjects will qualify if both of the following conditions apply:
• Subject has failed treatment with diet and exercise for at least one month prior to Screening
• Subject has received less than 7 days of any antidiabetic therapy within the 3 months prior to Screening Diagnosis of type 2 diabetes must be based on current American Diabetes Association criteria.
• 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 (greater than or equal to 0.26 nmol per L). (If this screening criterion is not met, the subject still qualifies if C-peptide greater than or equal to1.5 ng per mL (greater than or equal to 0.50 nmol per L) 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 (greater than or equal to 120 gm per L) for males and greater than or equal to 10 g per dL (greater than or equal to 100 gm per L) for females
• Alanine aminotransferase less than or equal to 3 times the upper limit of normal
• Serum creatinine less than or equal to 2.0 mg per dL (less than or equal to 17 micromol per L)
• Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid
• Neither pregnant (confirmed by laboratory testing in females of childbearing potential) 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.

You may not qualify if:

• Urine albumin to creatinine ratio of greater than1000 μg per mg (greater than 113 mg per mol) 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 1 or cervical intraepithelial neoplasia 2 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 study drug following enrollment in the study) is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)

Sponsors & Collaborators

• Takeda: lead

Study Sites (67)

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Birmingham, Alabama, United States

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Peoria, Arizona, 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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Lafayette, 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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Washington D.C., District of Columbia, United States

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Cocoa Beach, Florida, United States

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Kissimmee, Florida, United States

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Longwood, 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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Honolulu, Hawaii, United States

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Idaho Falls, Idaho, 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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Baltimore, Maryland, United States

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Sudbury, Massachusetts, 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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Morehead City, North Carolina, United States

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Pinehurst, 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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Tulsa, Oklahoma, 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, Chile

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Multiple Cities, Czechia

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Multiple Cities, Dominican Republic

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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, Poland

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Multiple Cities, South Africa

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Multiple Cities, United Kingdom

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Related Publications (2)

• DeFronzo RA, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 010 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care. 2008 Dec;31(12):2315-7. doi: 10.2337/dc08-1035. Epub 2008 Sep 22.

  PMID: 18809631 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

Condition Hierarchy (Ancestors)

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

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: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: February 3, 2012
• Results First Posted: August 29, 2011

Record last verified: 2012-02

Locations

GU (1); GB (1); HU (1); ME (1); DE (1); PE (1); NL (1); DO (1); BR (1); ZA (1); US (50); AU (1); CL (1); NZ (1); CZ (1); AR (1); IN (1); PL (1)