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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving treatment P | Placebo Comparator | Eligible subjects will receive placebo twice daily along with metformin twice daily for 13 days. |
|
| Subjects receiving treatment A | Experimental | Eligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days. |
|
| Subjects receiving treatment B | Experimental | Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK189075 | Drug | GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical laboratory tests, ECGs, physical exam & adverse events: | screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days) | |
| Home diary of blood sugar results, adverse events and drug dosing. | throughout the study (approximately 50 days) |
| Measure | Description | Time Frame |
|---|---|---|
| study drug blood levels: | Dosing Days 1 & 13 metformin blood levels: Days -1 & 13 | |
| Blood glucose & insulin levels following oral glucose challenge: | Dosing Days -1 & 13 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miami | Florida | 33169 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34120651 | Derived | Dobbins R, Hussey EK, O'Connor-Semmes R, Andrews S, Tao W, Wilkison WO, Cheatham B, Sagar K, Hanmant B. Assessment of safety and tolerability of remogliflozin etabonate (GSK189075) when administered with total daily dose of 2000 mg of metformin. BMC Pharmacol Toxicol. 2021 Jun 13;22(1):34. doi: 10.1186/s40360-021-00502-0. |
| Label | URL |
|---|---|
| Results for study KG2110243 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin | Drug | Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams. |
|
| Placebo | Drug | Placebo will be available as an oral tablets. |
|
| fluid intake & output |
| dosing Days -1 - 3, 13 |
| San Antonio |
| Texas |
| 78209 |
| United States |
| GSK Investigational Site | Buenos Aires | 1425 | Argentina |
| GSK Investigational Site | Berlin | 14050 | Germany |