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The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone | Drug | |||
| glyburide | Drug | |||
| metformin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to the primary action point (monotherapy failure). |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP). |
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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 | Anniston | Alabama | 36207 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12351470 | Result | Viberti G, Kahn SE, Greene DA, Herman WH, Zinman B, Holman RR, Haffner SM, Levy D, Lachin JM, Berry RA, Heise MA, Jones NP, Freed MI. A diabetes outcome progression trial (ADOPT): an international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1737-43. doi: 10.2337/diacare.25.10.1737. | |
| 17116177 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 49653/048 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| GSK Investigational Site | Città Di Castello (PG) | Umbria | 06012 | Italy |
| GSK Investigational Site | Florence | 50134 | Italy |
| GSK Investigational Site | La Spezia | 19100 | Italy |
| GSK Investigational Site | Lecce | 73100 | Italy |
| GSK Investigational Site | Milan | 20132 | Italy |
| GSK Investigational Site | Palermo | 90127 | Italy |
| GSK Investigational Site | Parma | 43100 | Italy |
| GSK Investigational Site | Perugia | 06126 | Italy |
| GSK Investigational Site | Rovigo | 45100 | Italy |
| GSK Investigational Site | S. Benedetto TR (AP) | Italy |
| GSK Investigational Site | San Giovanni Rotondo FG | Italy |
| GSK Investigational Site | Sassari | Italy |
| GSK Investigational Site | Terni | 05100 | Italy |
| GSK Investigational Site | Torino | 10126 | Italy |
| GSK Investigational Site | Udine | 33100 | Italy |
| GSK Investigational Site | Vicenza | 36100 | Italy |
| GSK Investigational Site | 's-Hertogenbosch | 5223 GV | Netherlands |
| GSK Investigational Site | De Bilt | 3731 DN | Netherlands |
| GSK Investigational Site | Geleen | 6166 GR | Netherlands |
| GSK Investigational Site | Hengelo | 7555 DL | Netherlands |
| GSK Investigational Site | Huizen | 1271 BB | Netherlands |
| GSK Investigational Site | Losser | 7581 BV | Netherlands |
| GSK Investigational Site | Losser | 7582 BD | Netherlands |
| GSK Investigational Site | Rijswijk | 2281 AK | Netherlands |
| GSK Investigational Site | Roelofarendsveen | 2371 RB | Netherlands |
| GSK Investigational Site | Woerden | 3443 GG | Netherlands |
| GSK Investigational Site | Hamar | 2317 | Norway |
| GSK Investigational Site | Paradis | 5231 | Norway |
| GSK Investigational Site | Skedsmokorset | N-2020 | Norway |
| GSK Investigational Site | Albaida (Valencia) | Spain |
| GSK Investigational Site | Basurto/Bilbao | 48013 | Spain |
| GSK Investigational Site | Benassal (Castellón) | 12160 | Spain |
| GSK Investigational Site | Benicasim (Castellón) | Spain |
| GSK Investigational Site | Bilbao | 48013 | Spain |
| GSK Investigational Site | Cartagena | 30203 | Spain |
| GSK Investigational Site | Cáceres | 10005 | Spain |
| GSK Investigational Site | El Palmar (Murcia) | 30120 | Spain |
| GSK Investigational Site | Elche (Alicante) | 03202 | Spain |
| GSK Investigational Site | Elda-Alicante | 03600 | Spain |
| GSK Investigational Site | Figueras | 17600 | Spain |
| GSK Investigational Site | Girona | Spain |
| GSK Investigational Site | Granollers (Barcelona) | 08400 | Spain |
| GSK Investigational Site | Jerez (Cadiz) | 11047 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Mataró | 08034 | Spain |
| GSK Investigational Site | Málaga | 29009 | Spain |
| GSK Investigational Site | Mérida | 6800 | Spain |
| GSK Investigational Site | Olleria, Valencia | 46850 | Spain |
| GSK Investigational Site | Onda/Castellón | 12200 | Spain |
| GSK Investigational Site | Orihuela (Alicante) | 03314 | Spain |
| GSK Investigational Site | Plasencia | 10600 | Spain |
| GSK Investigational Site | Pontevedra | 36071 | Spain |
| GSK Investigational Site | Sagunto/Valencia | 46520 | Spain |
| GSK Investigational Site | San Juan (Alicante) | 03550 | Spain |
| GSK Investigational Site | San Vincente Raspeig (Alicante) | 03690 | Spain |
| GSK Investigational Site | Santa Coloma de Gramanet (Barcelona) | 08923 | Spain |
| GSK Investigational Site | Santa Cruz de Tenerife | 38010 | Spain |
| GSK Investigational Site | Tereul | 44002 | Spain |
| GSK Investigational Site | Toledo | 45004 | Spain |
| GSK Investigational Site | Torrelavega/Santander | 39300 | Spain |
| GSK Investigational Site | Valencia | 46017 | Spain |
| GSK Investigational Site | Valencia | 46830 | Spain |
| GSK Investigational Site | Valencia | Spain |
| GSK Investigational Site | Valladolid | 47010 | Spain |
| GSK Investigational Site | Vallda (Valencia) | Spain |
| GSK Investigational Site | Villajoyosa - Alicante | 03570 | Spain |
| GSK Investigational Site | Zamora | 49021 | Spain |
| GSK Investigational Site | Zaragoza | 50003 | Spain |
| GSK Investigational Site | Älta | 138 21 | Sweden |
| GSK Investigational Site | Degerberga | 297 31 | Sweden |
| GSK Investigational Site | Gimo | SE-747 43 | Sweden |
| GSK Investigational Site | Malmö | SE-214 26 | Sweden |
| GSK Investigational Site | Stockholm | SE-114 35 | Sweden |
| GSK Investigational Site | Aberdeen | Aberdeenshire | AB25 2AY | United Kingdom |
| GSK Investigational Site | Sandy | Bedfordshire | SG19 3JR | United Kingdom |
| GSK Investigational Site | Reading | Berkshire | RG2 7AG | United Kingdom |
| GSK Investigational Site | Llanelli | Carmarthenshire | SA14 8QF | United Kingdom |
| GSK Investigational Site | Warrington | Cheshire | WA5 1QC | United Kingdom |
| GSK Investigational Site | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| GSK Investigational Site | Poole | Dorset | United Kingdom |
| GSK Investigational Site | Barry | Glamorgan | CF63 4HP | United Kingdom |
| GSK Investigational Site | Cardiff | Glamorgan | CF14 9BB | United Kingdom |
| GSK Investigational Site | Hemel Hempstead | Hertfordshire | HP2 4AD | United Kingdom |
| GSK Investigational Site | Stevenage | Hertfordshire | United Kingdom |
| GSK Investigational Site | Airdrie | Lanarkshire | ML6 0JS | United Kingdom |
| GSK Investigational Site | Glasgow | Lanarkshire | G81 4SA | United Kingdom |
| GSK Investigational Site | Bolton | Lancashire | United Kingdom |
| GSK Investigational Site | Chorley | Lancashire | PR7 1NY | United Kingdom |
| GSK Investigational Site | Edinburgh | Midlothian | EH3 9YW | United Kingdom |
| GSK Investigational Site | Wellingborough | Northamptonshire | NN8 4RW | United Kingdom |
| GSK Investigational Site | Nottingham | Nottinghamshire | NG3 7DQ | United Kingdom |
| GSK Investigational Site | Haverfordwest | Pembrokeshire | SA61 1RN | United Kingdom |
| GSK Investigational Site | Frome | Somerset | BA11 1EZ | United Kingdom |
| GSK Investigational Site | Crawley | Sussex West | RH10 1LL | United Kingdom |
| GSK Investigational Site | Nuneaton | Warwickshire | CV10 7DJ | United Kingdom |
| GSK Investigational Site | Rugby | Warwickshire | CV21 3SP | United Kingdom |
| GSK Investigational Site | Livingston | West Lothian | EH54 6PP | United Kingdom |
| GSK Investigational Site | Melksham | Wiltshire | SN12 6UN | United Kingdom |
| GSK Investigational Site | Trowbridge | Wiltshire | BA14 8TG | United Kingdom |
| GSK Investigational Site | Barnsley | S70 3RJ | United Kingdom |
| GSK Investigational Site | Bath | BA2 3HT | United Kingdom |
| GSK Investigational Site | Bradford | BD7 3EE | United Kingdom |
| GSK Investigational Site | Cardiff | CF5 4AE | United Kingdom |
| GSK Investigational Site | Co.Antrim | United Kingdom |
| GSK Investigational Site | Doncaster | DN1 2EG | United Kingdom |
| GSK Investigational Site | Doncaster | DN9 1EP | United Kingdom |
| GSK Investigational Site | Gateshead | NE9 6SX | United Kingdom |
| GSK Investigational Site | Glasgow | G51 4TF | United Kingdom |
| GSK Investigational Site | Glenrothes | United Kingdom |
| GSK Investigational Site | Irvine | KA12 OAY | United Kingdom |
| GSK Investigational Site | Kent | TN11 9HL | United Kingdom |
| GSK Investigational Site | Leicester | LE3 8GS | United Kingdom |
| GSK Investigational Site | London | SE1 9RT | United Kingdom |
| GSK Investigational Site | London | W1M 7AB | United Kingdom |
| GSK Investigational Site | Newtownabbey | BT36 4PP | United Kingdom |
| GSK Investigational Site | Peterborough | PE7 3JL | United Kingdom |
| GSK Investigational Site | Swansea | SA4 4BY | United Kingdom |
| GSK Investigational Site | Wakefield | WF1 4DG | United Kingdom |
| GSK Investigational Site | Wigan | WN1 1XX | United Kingdom |
| Result |
| Viberti G, Lachin J, Holman R, Zinman B, Haffner S, Kravitz B, Heise MA, Jones NP, O'Neill MC, Freed MI, Kahn SE, Herman WH; ADOPT Study Group. A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of Type 2 diabetic patients in North America and Europe. Diabet Med. 2006 Dec;23(12):1289-94. doi: 10.1111/j.1464-5491.2006.02022.x. |
| 17145742 | Result | Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. doi: 10.1056/NEJMoa066224. Epub 2006 Dec 4. |
| 16873701 | Result | Kahn SE, Zinman B, Haffner SM, O'Neill MC, Kravitz BG, Yu D, Freed MI, Herman WH, Holman RR, Jones NP, Lachin JM, Viberti GC; ADOPT Study Group. Obesity is a major determinant of the association of C-reactive protein levels and the metabolic syndrome in type 2 diabetes. Diabetes. 2006 Aug;55(8):2357-64. doi: 10.2337/db06-0116. |
| 15561950 | Result | Zinman B, Kahn SE, Haffner SM, O'Neill MC, Heise MA, Freed MI; ADOPT Study Group. Phenotypic characteristics of GAD antibody-positive recently diagnosed patients with type 2 diabetes in North America and Europe. Diabetes. 2004 Dec;53(12):3193-200. doi: 10.2337/diabetes.53.12.3193. |
| 38837240 | Derived | El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2. |
| 32501595 | Derived | Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2. |
| 21454723 | Derived | Lachin JM, Viberti G, Zinman B, Haffner SM, Aftring RP, Paul G, Kravitz BG, Herman WH, Holman RR, Kahn SE; ADOPT Study Group. Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapy. Clin J Am Soc Nephrol. 2011 May;6(5):1032-40. doi: 10.2215/CJN.09291010. Epub 2011 Mar 31. |
| 19808911 | Derived | Kahn SE, Haffner SM, Viberti G, Herman WH, Lachin JM, Kravitz BG, Yu D, Paul G, Holman RR, Zinman B; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone decreases C-reactive protein to a greater extent relative to glyburide and metformin over 4 years despite greater weight gain: observations from a Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2010 Jan;33(1):177-83. doi: 10.2337/dc09-1661. Epub 2009 Oct 6. |
| 18223031 | Derived | Kahn SE, Zinman B, Lachin JM, Haffner SM, Herman WH, Holman RR, Kravitz BG, Yu D, Heise MA, Aftring RP, Viberti G; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2008 May;31(5):845-51. doi: 10.2337/dc07-2270. Epub 2008 Jan 25. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 49653/048 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 49653/048 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 49653/048 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 49653/048 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 49653/048 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 49653/048 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| D005905 | Glyburide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
Not provided
Not provided