A Phase 1 interventional study of GSK189075 and Metformin in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 4 sites in 3 countries. Open to participants aged 30 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-09-06.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
Eligible subjects will receive placebo twice daily along with metformin twice daily for 13 days.
Drug: Metformin · Drug: Placebo
Eligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days.
Drug: GSK189075 · Drug: Metformin
Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days.
Drug: GSK189075 · Drug: Metformin
GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.
Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.
Placebo will be available as an oral tablets.
Clinical laboratory tests, ECGs, physical exam & adverse events:
Time frame: screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days)
Home diary of blood sugar results, adverse events and drug dosing.
Time frame: throughout the study (approximately 50 days)
study drug blood levels:
Time frame: Dosing Days 1 & 13 metformin blood levels: Days -1 & 13
Blood glucose & insulin levels following oral glucose challenge:
Time frame: Dosing Days -1 & 13
fluid intake & output
Time frame: dosing Days -1 - 3, 13
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline