Autopsy report · NCT01829477

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

“Due to potential concerns about liver safety (See Detailed Description)”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 10 months before it stopped.
• 33 participants enrolled.
• Results were posted on the registry 2 years 4 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Takeda

Sponsor type

Industry

Conditions

Diabetes Mellitus, Type 2

Interventions

TAK-875; TAK-875 Placebo; Glimepiride

Participants

33

Sites

69

Countries

Bulgaria, Canada, Hungary, Poland, Romania, Slovakia, United States

Trials that died the same way

• Efficacy and Safety Study of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus
  “Hepatic safety signal identified.” (65% match in meaning)
• Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers
  “Due to a lack of safety and efficacy.” (57% match in meaning)
• Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
  “Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.” (57% match in meaning)
• A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
  “This trial was prematurely terminated on Dec 9 2010 due to safety concerns, specifically emerging evidence of hepatic injury.” (56% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.