Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes

NCT01647542 | Terminated Phase 3 Results DMC

• 3 other identifiers: TAK-875_307U1111-1129-78651015011378
• Study Type: interventional
• Target: 393
• Locations: 5 countries
• Sites: 51

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific adults with type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 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 (3)

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

  Week 24

• Change in Fasting Plasma Glucose From Baseline to Week 24

  Baseline and Week 24

• Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24

  Baseline and Week 24

Study Arms (3)

TAK-875 25 mg

EXPERIMENTAL

TAK-875 25 mg tablets, orally, once daily for up to 24 weeks.

Drug: TAK-875

TAK-875 50 mg

EXPERIMENTAL

TAK-875 50 mg tablets, orally, once daily for up to 24 weeks.

Drug: TAK-875

Placebo

PLACEBO COMPARATOR

TAK-875 placebo-matching tablets, orally, once daily for up to 24 weeks.

Drug: TAK-875 Placebo

Interventions

TAK-875 DRUG

TAK-875 tablets

TAK-875 25 mg; TAK-875 50 mg

TAK-875 Placebo DRUG

TAK-875 placebo-matching tablets

Placebo

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 patient is capable of understanding and complying with protocol requirements.
• The patient or, when applicable, the patient'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, aged at least 18 years or over the legal age of consent in countries where that is greater than 18 years, with a historical diagnosis of T2DM.
• Has an HbA1c of 7.0% to 10.0%, inclusive at screening, and has been treated with diet and exercise for at least 3 months.
• Has a body mass index (BMI) of ≤45 kg/m\^2 at screening.
• Patients regularly using, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. However, PRN (as needed) use of prescription or over-the-counter medication is allowed at the discretion of the investigator.
• A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the 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 home glucose monitor and consistently record his or her own blood glucose concentrations and complete subject diaries.

You may not qualify if:

• Is unable to understand the official language (verbal or written) of the country for which a certified translation of the approved informed consent is available.
• Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress.
• Has hemoglobin a level ≤12 g/dL (≤120 g/L) (males) and ≤10 g/dL (≤100 g/L) (females) at the Screening Visit.
• Has a history of any hemoglobinopathy that may affect determination of HbA1c.
• Donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
• 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 3 months prior or at Screening.
• Has a serum creatinine level of ≥1.5 mg/dL (males) and ≥1.4 mg/dL (females) and/or estimated glomerular filtration rate (GFR) \<60 mL/min/1.73m\^2 at Screening.
• Has uncontrolled thyroid disease.
• Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• Has a history or treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
• Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2.0x the upper limit of normal range (ULN) at Screening.
• Has a total bilirubin level greater than the ULN at Screening. Exception: if a patient has documented Gilbert's Syndrome, they will be allowed with an elevated bilirubin level per the investigator's discretion.
• Has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
• If a patient has no known history of HBV infection, then a HBV Screening test panel should be done. If the test is positive and there is clinical manifestation of active infection per Investigator's diagnosis, then the patient should be excluded. In addition, if the patient is considered to need antiviral treatment, the patient should be excluded. (If the test results indicate only an hepatitis B surface antigen (HBsAg) carrier without any clinical manifestation of active infection, and no antiviral treatment is needed, then the patient could be enrolled provided all other criteria are met.)
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (51)

Unknown Facility

Brookvale, New South Wales, Australia

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Maroubra, New South Wales, Australia

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Mosman, New South Wales, Australia

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Woy Woy, New South Wales, Australia

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Elizabeth Vale, South Australia, Australia

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Hefei, Anhui, China

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Beijing, Beijing Municipality, China

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Beijing,P.R., Beijing Municipality, China

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Chongqing, Chongqing Municipality, China

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Fuzhou, Fujian, China

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Xiamen, Fujian, China

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Guangzhou, Guangdong, China

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Guiyang, Guizhou, China

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Shijiazhuang, Hebei, China

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Harbin, Heilongjiang, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Chenzhou, Hunan, China

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Nanjing, Jiangsu, China

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Suzhou, Jiangsu, China

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Changchun, Jilin, China

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Changchun City, Jilin Province, Jilin, China

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Xi'an, Shaanxi, China

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Shanghai, Shanghai Municipality, China

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Xi’an, Shanxi, China

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Chengdu, Sichuan, China

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Tianjin, Tianjin Municipality, China

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Beijing, China

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Chongqing, China

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Guangzhou, China

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Guiyang, China

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Heilongjiang, China

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Nanjing, China

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Shanghai, China

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Tianjin, China

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Auckland, New Zealand

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Hamilton, New Zealand

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Rotorua, New Zealand

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Tauranga, New Zealand

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Wellington, New Zealand

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Goyang-si, Gyeonggi-do, South Korea

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Seongnam-si, Gyeonggi-do, South Korea

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Suwon, Gyeonggi-do, South Korea

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Gyeonggi-do, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Kaohsiung City, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

Location

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

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: July 19, 2012
• First Posted: July 23, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 11, 2015
• Results First Posted: August 19, 2015

Record last verified: 2015-10

Locations

AU (5); TW (5); CN (30); NZ (5); KR (6)