Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis

NCT02015780 | Withdrawn Phase 3

• 3 other identifiers: TAK-875_311U1111-1146-55462013-003414-40
• Study Type: interventional
• Target: N/A
• Locations: 7 countries
• Sites: 30

Brief Summary

To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) stage 4 or 5 on dialysis.

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16

  The change from Baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 16.

  Baseline and Week 16

Secondary Outcomes (3)

• Percentage of participants with HbA1c <7.5% at Week 16

  Week 16

• Change from Baseline in Fasting Plasma Glucose (FPG) at Week 16

  Baseline and Week 16

• Change from Baseline in Total Daily Dose of Insulin at Week 52

  Baseline and Week 52

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Fasiglifam placebo-matching tablets, once daily, and stable antihyperglycemic therapy for up to 16 weeks. Then Fasiglifam placebo-matching tablets, once daily and antihyperglycemic therapy, adjusted as necessary per the Investigator's discretion, for up to 36 weeks.

Drug: Placebo; Drug: Antihyperglycemic therapy

Fasiglifam

EXPERIMENTAL

Fasiglifam 50 mg tablets, once daily and stable antihyperglycemic therapy for up to 16 weeks. Then Fasiglifam 50 mg tablets, once daily and antihyperglycemic therapy, adjusted as necessary per the Investigator's discretion, for up to 36 weeks.

Drug: Fasiglifam; Drug: Antihyperglycemic therapy

Interventions

Fasiglifam DRUG

Fasiglifam tablets

Also known as: TAK-875

Fasiglifam

Placebo DRUG

Fasiglifam placebo-matching tablets

Placebo

Antihyperglycemic therapy DRUG

Including any of the following alone or in combination: insulin, sulfonylurea, thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, meglitinides, alpha-glucosidase inhibitors or dipeptidyl peptidase-4 (DPP-4) inhibitors acceptable by local practice guidelines.

Fasiglifam; 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 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 18 years of age or older with a historical diagnosis of Type 2 diabetes mellitus (T2DM).
• Is on antihyperglycemic therapy that is acceptable by local practice guidelines, including any of the following alone or in combination: insulin, sulfonylurea, thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, meglitinides, alpha-glucosidase inhibitors or dipeptidyl peptidase-4 (DPP-4) inhibitors. Existing glucose-lowering therapy must have remained stable in regimen without significant changes in dosage based on investigator judgment for ≥8 weeks before study entry.
• Has for ≥ 3 months prior to Screening, chronic kidney disease (CKD) stage 4 (defined as estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m\^2 by Modification of Diet in Renal Disease (MDRD) formula), or CKD stage 5 on dialysis (ie eGFR \<15 ml/min/1.73 m\^2 by MDRD formula).
• Has an HbA1c level ≥7.5 and ≤10.5%, inclusive, and fasting plasma glucose \<270 mg/dL (15.0 mmol/L) at Screening.
• Has a C-peptide level ≥ 0.33 mmol/L at Screening.
• Has a body mass index (BMI) ≤45 kg/m\^2 at Screening.
• A female of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely 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 participant diaries.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Screening or has received an investigational antihyperglycemic drug within the 3 months prior to Screening.
• Was randomized into a previous fasiglifam (TAK-875) study.
• 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, sibling) or may consent under duress.
• Received any blood products within 12 weeks prior to Screening.
• Has a hemoglobin ≤9 g/dL (≤90 g/L) at Screening.
• Has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at Screening.
• Has history of cancer that has been in remission for \<5 years prior to Screening. Exception: 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 \>2.0 x upper limit of normal (ULN) at Screening.
• Has a total bilirubin level greater than the ULN at Screening.
• Has uncontrolled secondary hyperparathyroidism as determined by the investigator.
• Has had any requirement for acute (\<3 months) dialysis or initiated on dialysis within the previous 3 months, has CKD stage 4 with rapidly deteriorating kidney function likely to require renal replacement therapy (dialysis or kidney transplantation) within 12 months of enrollment (patients on dialysis must be on this procedure for at least 3 months, not less than 3 months).
• Has uncontrolled thyroid disease as determined by the investigator.
• Has had gastric banding, or gastric bypass surgery within 1 year prior to Screening.
• Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
• Has a history of significant cerebrovascular and/or cardiovascular diseases including myocardial infarction, unstable angina, stroke, transient ischemic attack, New York Heart Association class III/IV congestive heart failure and/or left ventricular ejection fraction ≤40% within 12 months prior to Screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (30)

Unknown Facility

Whittier, California, United States

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Westminster, Colorado, United States

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Tampa, Florida, United States

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Rosedale, New York, United States

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Cincinnati, Ohio, United States

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Charleston, South Carolina, United States

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San Antonio, Texas, United States

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Pazardzhik, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Baja, Hungary

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Gyula, Hungary

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Kaposvár, Hungary

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Szigetvár, Hungary

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Zalaegerszeg, Hungary

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Zamość, Poland

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Banská Bystrica, Slovakia

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Bardejov, Slovakia

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Myjava, Slovakia

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Púchov, Slovakia

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Senica, Slovakia

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Svidník, Slovakia

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Trstená, Slovakia

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Bloemfontein, Free State, South Africa

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Cape Town, Western Cape, South Africa

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Worcester, Western Cape, South Africa

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Donetsk, Ukraine

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Kyiv, Ukraine

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Ternopil, Ukraine

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Vinnytsia, Ukraine

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

TAK-875

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

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: December 13, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

US (7); UA (4); ZA (3); HU (5); BU (3); SL (7); PL (1)