Efficacy and Safety of TAK-875 in Subjects With Type 2 Diabetes Mellitus

NCT01007097 | Completed Phase 2

• 2 other identifiers: TAK-875_201U1111-1111-1019
• Study Type: interventional
• Target: 426
• Locations: 3 countries
• Sites: 71

Brief Summary

The purpose of this study is to determine the safety and efficacy of multiple doses of TAK-875, once daily (QD), in subjects with Type 2 Diabetes Mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Non Insulin Dependent; Diabetes Mellitus, Type II; Type 2 Diabetes Mellitus; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Glycosylated Hemoglobin at Week 12.

  Baseline and Week 12

Secondary Outcomes (3)

• Change from Baseline in Fasting Plasma Glucose at Week 12.

  Baseline and Week 12

• Change from Baseline in Body Weight at Week 12.

  Baseline and Week 12

• Incidence of Hypoglycemia During Double-Blind Treatment Period.

  Per Occurrence (up to 12 weeks)

Study Arms (7)

TAK-875 6.25 mg QD

EXPERIMENTAL

Drug: TAK-875

TAK-875 25 mg QD

EXPERIMENTAL

Drug: TAK-875

TAK-875 50 mg QD

EXPERIMENTAL

Drug: TAK-875

TAK-875 100 mg QD

EXPERIMENTAL

Drug: TAK-875

TAK-875 200 mg QD

EXPERIMENTAL

Drug: TAK-875

Glimepiride 2 mg or 4mg QD

ACTIVE COMPARATOR

Drug: Glimepiride

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAK-875 DRUG

TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.

TAK-875 6.25 mg QD

Glimepiride DRUG

TAK-875 placebo-matching tablets and Glimepiride 2 mg or 4mg, capsules, orally, once daily for up to 12 weeks.

Also known as: Amaryl®, Glyree

Glimepiride 2 mg or 4mg QD

Placebo DRUG

TAK-875 placebo-matching tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 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:

• Participant meets 1 of the following criteria:
• A historical diagnosis of type 2 diabetes mellitus without the chronic use of antidiabetic therapy within 8 weeks prior to Screening, and with at least an 8-week documented history of a diet and exercise plan at Screening.
• A historical diagnosis of mellitus and stable on at least 1500 mg per day or the respective (individually) maximal tolerated dose of metformin as monotherapy for at least 2 months prior to Screening.
• Has a glycosylated hemoglobin level at Screening between 7.5% and 10.0%, inclusive, if on metformin and greater than or equal to 7.5% to less than 11% if treated with diet and exercise alone.
• Has a fasting plasma glucose level less than 260 mg/dL, at Screening.
• Has a fasting C-peptide concentration greater than or equal to 0.8 ng/mL at Screening.
• If participant takes any chronic medications, the dose of these medications must have been stable (no change in dose or drug) for at least 4 weeks prior to Screening.
• Participant's body mass index at Screening is greater than or equal to 23 and less than or equal to 45 kg/m2.
• Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations.
• Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study and for 1 month after the last dose of study drug.
• Compliance with single-blind study medication during the Run-in Period is at least 80% and does not exceed 120% based on tablet counts performed by the study staff.

You may not qualify if:

• Has systolic blood pressure greater than 160 mm Hg or diastolic pressure greater than 100 mm Hg at Screening or Baseline (as confirmed by repeat measurement 30 minutes after initial measurement).
• Has history of cancer that has been in remission for less than 5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
• Has a creatine phosphokinase level greater than or equal to 5 times the upper limit of normal at Screening.
• Has a hemoglobin level of less than or equal to 12 g/dL (120 gm/L) for men and less than or equal to 10 g/dL (100 gm/L) for women at Screening.
• Has alanine aminotransferase and aspartate aminotransferase levels greater than or equal to 2.5 times upper limit of normal at Screening.
• Has a total bilirubin level greater than or equal to 1.5 mg/dL at Screening.
• The subject has a serum triglyceride concentration greater than or equal to 400 mg/dL at Screening.
• Has an estimated glomerular filtration rate less than or equal to 60 mL/min using the Modification of Diet in Renal Disease equation at Screening.
• Has abnormal thyroid-stimulating hormone levels.
• Has a positive test result for hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus.
• Has macro-albuminuria at Screening
• Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• Has diabetic gastroparesis that in the investigator's opinion is moderate or severe and hence may impair absorption of study medication.
• Has had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram, cerebrovascular accident or transient ischemic attack within 6 months prior or at Screening.
• Has a history of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.

Sponsors & Collaborators

• Takeda: lead

Study Sites (71)

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Birmingham, Alabama, United States

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Hoover, Alabama, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Burlingame, California, United States

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Chula Vista, California, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Los Gatos, California, United States

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Norwalk, California, United States

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Orange, California, United States

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Colorado Springs, Colorado, United States

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Pueblo, Colorado, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Hialeah, Florida, United States

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Jupiter, Florida, United States

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Miami, 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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Panama City, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Sandy Springs, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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La Grange, Illinois, United States

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Sunset, Louisiana, United States

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Portland, Maine, United States

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Parkville, Maryland, United States

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Rockville, Maryland, United States

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Southfield, Michigan, United States

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Olive Branch, Mississippi, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Camden, New Jersey, United States

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West Seneca, New York, United States

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Asheboro, North Carolina, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Morehead City, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Carlisle, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Perrysburg, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Peak, South Carolina, United States

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Taylors, South Carolina, United States

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Varnville, South Carolina, United States

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Corpus Christi, Texas, United States

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Hurst, Texas, United States

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North Richland Hills, Texas, United States

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Odessa, Texas, United States

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San Antonio, Texas, United States

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Draper, Utah, United States

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Salt Lake City, Utah, United States

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Spokane, Washington, United States

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Guatemala City, Departamento de Guatemala, Guatemala

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Cuernavaca, Morelos, Mexico

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Monterrey, Nuevo León, Mexico

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Tampico, Tamaulipas, Mexico

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Related Publications (1)

• Burant CF, Viswanathan P, Marcinak J, Cao C, Vakilynejad M, Xie B, Leifke E. TAK-875 versus placebo or glimepiride in type 2 diabetes mellitus: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2012 Apr 14;379(9824):1403-11. doi: 10.1016/S0140-6736(11)61879-5. Epub 2012 Feb 27.

  PMID: 22374408 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

TAK-875; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 2, 2009
• First Posted: November 3, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 13, 2016

Record last verified: 2016-03

Locations

GU (1); US (64); ME (6)