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Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasiglifam (TAK-875) Compared to Placebo as Add-on to Preexisting Antihyperglycemic Therapy Over 16 Weeks With 36-week Extension in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or Stage 5 on Dialysis

NCT02015780•Takeda

View on ClinicalTrials.gov

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.

Detailed Description

The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to treat people who have diabetes and chronic kidney disease. This study will look at glycemic control in people who take fasiglifam in addition to standard antihyperglycemic therapy. The study will enroll approximately 164 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Fasiglifam 50 mg; * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient. All participants will be asked to take one tablet at the same time each day throughout the study in addition to their current antihyperglycemic therapy. All participants will be asked to record any time they have hypoglycemia signs and symptoms in a diary. This multi-center trial will be conducted in the United States and European regions. The overall time to participate in this study is approximately 57 weeks. Participants will make 17 visits to the clinic. Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks. For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
•2. 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.
•3. Male or female and 18 years of age or older with a historical diagnosis of Type 2 diabetes mellitus (T2DM).
•4. 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.
•5. 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).
•6. Has an HbA1c level ≥7.5 and ≤10.5%, inclusive, and fasting plasma glucose \<270 mg/dL (15.0 mmol/L) at Screening.
•7. Has a C-peptide level ≥ 0.33 mmol/L at Screening.
•8. Has a body mass index (BMI) ≤45 kg/m\^2 at Screening.
•9. 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.
•10. 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.

Exclusion Criteria

•1. 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.
•2. Was randomized into a previous fasiglifam (TAK-875) study.
•3. 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.
•4. Received any blood products within 12 weeks prior to Screening.
•5. Has a hemoglobin ≤9 g/dL (≤90 g/L) at Screening.
•6. Has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at Screening.
•7. 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.
•8. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2.0 x upper limit of normal (ULN) at Screening.
•9. Has a total bilirubin level greater than the ULN at Screening.
•10. Has uncontrolled secondary hyperparathyroidism as determined by the investigator.
+14 more criteria

Locations (30)

Whittier, California, United States

Westminster, Colorado, United States

Tampa, Florida, United States

Rosedale, New York, United States

Cincinnati, Ohio, United States

Charleston, South Carolina, United States

San Antonio, Texas, United States

Pazardzhik, Bulgaria

Sofia, Bulgaria

Varna, Bulgaria

Key Dates

Start Date

December 1, 2013

Primary Completion Date

January 1, 2016

Completion Date

January 1, 2016

Last Updated

January 27, 2014

Conditions

Type 2 Diabetes MellitusChronic Kidney Disease

Interventions

Fasiglifam

DRUG

Placebo

DRUG

Antihyperglycemic therapy

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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