Autopsy report · NCT01725672
Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers
Cause of deathRegulatory or ethics
“Due to changes in EMA guidelines on modified release dosage forms (Feb 2013; EMA/CHMP/EWP/280/96). The Part B formulation would not meet the new guidelines.”
Life of this trial
- Registered 1 month after it had already started.
- Ran for about 11 months before it stopped.
- 20 participants enrolled.
- No results are posted on the registry.
Vital statistics
- Status
- Terminated
- Phase
- Phase 1
- Sponsor
- GlaxoSmithKline
- Sponsor type
- Industry
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Metformin, 500 mg extended release tablet; Metformin, 1000 mg extended release tablet; Glimepiride, 1 mg immediate release tablet; Glimepiride, 2 mg immediate release tablet; Metformin, 500 mg and Glimepiride, 1 mg extended release film coated tablet containing release controlling polymers; Metformin, 1000 mg and Glimepiride, 2 mg extended release film coated tablet containing release controlling polymers
- Participants
- 20
- Sites
- 1
- Countries
- Australia
Trials that died the same way
- A Phase I Trial Evaluating mFOLFOX6 and Avastin With Nexavar as First-Line Treatment for Metastatic Colorectal Cancer
“Dose limiting toxicity at the lowest planned dose level.”
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.