Bioequivalence of imeglimin tablet formulations, version 1
Research type
Research Study
Full title
A Phase 1, open-label, randomised, single-centre, 2-way crossover bioequivalence study comparing 2 formulations of imeglimin after single oral doses in healthy Caucasian subjects
IRAS ID
248666
Contact name
Adeep Puri
Contact email
Sponsor organisation
Poxel SA
Eudract number
2018-001102-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Imeglimin is an experimental treatment for type 2 diabetes. People with diabetes have high blood sugar. If diabetes isn’t treated, it can cause long-term health problems. \n\nIn healthy people, blood sugar is decreased by a hormone called insulin, which is made by the pancreas. People develop type 2 diabetes when their pancreas can’t make enough insulin, or their insulin doesn’t work properly, so their blood sugar is high.\n\nPrevious studies have shown that imeglimin reduces blood sugar by increasing the amount of insulin made by the pancreas. So far, imeglimin has been safe and well tolerated. At the highest doses, the most common side-effects have been abdominal pain, nausea and diarrhoea.\n\nDifferent tablet forms of imeglimin have been used in previous studies. We’re doing this study in healthy men and women to compare 2 of those: Tablet A and Tablet B. We aim to answer these questions.\n\n•\tDo the 2 tablet forms give the same blood and urine levels of imeglimin?\n•\tAre the 2 tablets identical in terms of tolerability (potential side effects after taking imeglimin)\n\n\nUp to 50 healthy Caucasian men and women, aged 18-55, will have 2 study sessions each. In each session, participants will take a single dose of imeglimin, as tablets: as Tablet A on one occasion and as Tablet B on the other. A computer will decide in which order they’ll do that. There will be at least 1 week between doses of imeglimin. \n\nThe study takes around 3 weeks to complete. Each participant will have: a screening visit in the 4 weeks before they start the study; 2 study sessions, each lasting 3 nights and 4 days; and a final follow up visit. \n\nA pharmaceutical company (Poxel SA) is funding the study.\n\nThe study will take place at 1 centre in London.\n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0267
Date of REC Opinion
17 Aug 2018
REC opinion
Favourable Opinion