Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

NCT00286429 | Completed Phase 3 Results

• 3 other identifiers: SYR-322-INS-0112005-004671-38U1111-1113-8369
• Study Type: interventional
• Target: 390
• Locations: 16 countries
• Sites: 60

Brief Summary

The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of 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 (32)

• 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)

Insulin

PLACEBO COMPARATOR

Drug: Insulin

Alogliptin 12.5 mg QD

EXPERIMENTAL

Drug: Alogliptin and insulin

Alogliptin 25 mg QD

EXPERIMENTAL

Drug: Alogliptin and insulin

Interventions

Alogliptin and insulin DRUG

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

Also known as: alogliptin, SYR110322

Alogliptin 12.5 mg QD

Insulin DRUG

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

Insulin

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 and currently treated with insulin alone (with or without metformin), and is inadequately controlled. Metformin dose must be stable for at least 8 weeks prior to Randomization.
• No treatment with antidiabetic agents other than insulin and metformin within the 8 weeks prior to Randomization.
• 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 greater than or equal to 1.5 ng per mL after a challenge test).
• Glycosylated hemoglobin concentration greater than or equal to 8.0% at Screening.
• Using a stable dose of insulin of at least 15 units but not more than 100 units per day for at least 8 weeks prior to Randomization. A dose of insulin that varies by up to 15% of the mean will be considered as stable.
• 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 to180 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 3 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 (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 own blood glucose concentrations with a home glucose monitor

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. (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 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 insulin and metformin is not allowed within the 8 weeks prior to Randomization and through the completion of the end-of treatment or early termination procedures. (Exception: if has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)

Sponsors & Collaborators

• Takeda: lead

Study Sites (60)

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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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Tustin, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Cocoa Beach, 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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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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Avon, Indiana, United States

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Evansville, Indiana, United States

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Lafayette, Indiana, 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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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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Medford, Oregon, United States

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Lansdale, 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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Cookeville, 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, 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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Related Publications (2)

• Rosenstock J, Rendell MS, Gross JL, Fleck PR, Wilson CA, Mekki Q. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab. 2009 Dec;11(12):1145-52. doi: 10.1111/j.1463-1326.2009.01124.x. Epub 2009 Sep 16.

  PMID: 19758359 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; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 3, 2012
• Results First Posted: August 12, 2011

Record last verified: 2012-02

Locations

US (45); DE (1); IN (1); NL (1); AU (1); HU (1); NZ (1); ZA (1); CZ (1); ME (1); AR (1); BR (1); PL (1); CL (1); GU (1); PE (1)