Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes

NCT01829477 | Terminated Phase 3 Results DMC

• 4 other identifiers: TAK-875_3092013-000007-17U1111-1138-8680164539
• Study Type: interventional
• Target: 33
• Locations: 7 countries
• Sites: 69

Brief Summary

The purpose of this study is to evaluate the effect of TAK-875 compared to placebo on glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in addition to diet and exercise.

Conditions

Diabetes Mellitus, Type 2

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

  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 24 relative to baseline.

  Baseline and Week 24

Secondary Outcomes (2)

• Percentage of Participants With HbA1c <7 % at Week 24.

  Week 24

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

Study Arms (2)

TAK-875 50 mg

EXPERIMENTAL

TAK-875 50 mg tablet, orally, once daily and glimepiride 6 mg (or Maximum Tolerated Dose), tablets, orally, once daily for up to 24 weeks.

Drug: TAK-875; Drug: Glimepiride

Placebo

PLACEBO COMPARATOR

TAK-875 placebo-matching tablet, orally, once daily and glimepiride 6 mg (or Maximum Tolerated Dose), tablets, orally, once daily for up to 24 weeks.

Drug: TAK-875 Placebo; Drug: Glimepiride

Interventions

TAK-875 DRUG

TAK-875 50 mg tablets

TAK-875 50 mg

TAK-875 Placebo DRUG

TAK-875 placebo-matching tablets

Placebo

Glimepiride DRUG

Glimepiride tablet.

Also known as: Amaryl

Placebo; TAK-875 50 mg

Eligibility Criteria

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

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Male or female and aged 18 or older with a historical diagnosis of type 2 diabetes mellitus (T2DM).
• Has a glycosylated hemoglobin (HbA1c) of 7.0% to10.0%, inclusive at screening, and has been treated with diet and exercise and a sulfonylurea for at least 12 weeks.
• Has a body mass index (BMI) ≤45 kg/m2 at Screening.
• Participants regularly using other, non-excluded medications, must be on a stable dose and regimen for at least 4 weeks prior to Screening. However, as needed (PRN) use of prescription or over-the-counter medication is allowed at the discretion of the investigator. Note: Participants who require initiation of a chronically administered medication(s) due to a disease or condition diagnosed at Screening must be re-screened after the new regimen has been stabilized.
• A female of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug.
• Is able and willing to monitor glucose with a sponsor-provided home glucose monitor and consistently record his or her own blood glucose concentrations and participant diaries.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
• Has participated in a previous TAK-875 study.
• Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• Has donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
• Has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening.
• Has a history of cancer that has been in remission for \<5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
• Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2.0x the upper limit of normal (ULN) at Screening.
• Has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome, the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
• Has a serum creatinine ≥1.5 mg/dL (≥133 μmol/L) \[if male\] or ≥1.4 mg/dL (≥124 μmol/L) \[if female\] and/or estimated (based on Modification of Diet in Renal Disease \[MDRD\] calculation) glomerular filtration rate (GFR) \<60 mL/min/1.73m2 (regardless of gender) at Screening.
• Has uncontrolled thyroid disease.
• Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• Has had gastric banding or gastric bypass surgery within 1 year prior to Screening.
• Has known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency, which increases risk for hemolytic anemia by sulfonylurea treatment.
• Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
• Had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram (ECG), cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (69)

Unknown Facility

Muscle Shoals, Alabama, United States

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Phoenix, Arizona, United States

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Fresno, California, United States

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Long Beach, California, United States

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National City, California, United States

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North Hollywood, California, United States

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Pismo Beach, California, United States

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Lakewood, Colorado, United States

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Boynton Beach, Florida, United States

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Bradenton, Florida, United States

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Coral Gables, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Conyers, Georgia, United States

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Chicago, Illinois, United States

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Lexington, Kentucky, United States

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Oxon Hill, Maryland, United States

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Flint, Michigan, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Haddon Heights, New Jersey, United States

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Rosedale, New York, United States

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Morehead City, North Carolina, United States

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Morganton, North Carolina, United States

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Maumee, Ohio, United States

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Hanleysville, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Laurens, South Carolina, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Spring, Texas, United States

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Tomball, Texas, United States

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Manassas, Virginia, United States

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Gabrovo, Bulgaria

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Oakville, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Budapest, Hungary

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Gödöllő, Hungary

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Kistelek, Hungary

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Komárom, Hungary

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Zalaegerszeg, Hungary

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Bialystok, Poland

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Gdansk, Poland

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Grodzisk Mazowiecki, Poland

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Kamieniec Ząbkowicki, Poland

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Lodz, Poland

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Oświęcim, Poland

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Poznan, Poland

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Puławy, Poland

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Rzeszów, Poland

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Zgierz, Poland

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Baia Mare, Romania

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Ploieşti, Romania

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Timișoara, Romania

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Dolný Kubín, Slovakia

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Levice, Slovakia

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Lučenec, Slovakia

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Pezinok, Slovakia

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Svidník, Slovakia

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Related Publications (1)

• Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.

  PMID: 30880443 DERIVED

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

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.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 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: April 9, 2013
• First Posted: April 11, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 1, 2016
• Results First Posted: June 1, 2016

Record last verified: 2016-04

Locations

PL (10); US (38); RO (3); HU (5); BU (3); CA (3); SL (7)