Diabetes Clinical Trial
— OptimiseOfficial title:
OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.
| NCT number | NCT00681850 |
| Other study ID # | D3560L00071 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2008 |
| Est. completion date | January 2010 |
| Verified date | June 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Demonstrate that the use of benchmarking improves quality of patient care, in particular the control of diabetes, lipids and blood pressure, by determining the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of follow-up.
| Status | Completed |
| Enrollment | 4027 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Provision of informed Consent - Patients suffering from diabetes type II, insulin dependent or not insulin dependent. Exclusion Criteria: - Type I diabetes - Pregnancy diabetes - Hospitalisation, as this is a primary care study - Patients who are member of the Belgian Diabetes Convention |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Aarschot | |
| Belgium | Research Site | Alsemberg | |
| Belgium | Research Site | Amay | |
| Belgium | Research Site | Antoing | |
| Belgium | Research Site | Antwerpen | |
| Belgium | Research Site | Anzegem | |
| Belgium | Research Site | ATH | |
| Belgium | Research Site | Baisy-thy | |
| Belgium | Research Site | Balleul | |
| Belgium | Research Site | Bastogne | |
| Belgium | Research Site | Battice | |
| Belgium | Research Site | Beerse | |
| Belgium | Research Site | Bellaire | |
| Belgium | Research Site | Bertogne | |
| Belgium | Research Site | Betekom | |
| Belgium | Research Site | Beveren | |
| Belgium | Research Site | Bilzen | |
| Belgium | Research Site | Binche | |
| Belgium | Research Site | Boezinge | |
| Belgium | Research Site | Boirs | |
| Belgium | Research Site | Borgerhout | |
| Belgium | Research Site | Bouillon | |
| Belgium | Research Site | Brain-l'alleud | |
| Belgium | Research Site | Brugge | |
| Belgium | Research Site | Bruxelles | |
| Belgium | Research Site | Cercxhe-heuseux | |
| Belgium | Research Site | Champion | |
| Belgium | Research Site | Clabeoq | |
| Belgium | Research Site | Corbion | |
| Belgium | Research Site | De Pinte | |
| Belgium | Research Site | Diest | |
| Belgium | Research Site | Dottignies | |
| Belgium | Research Site | Dworp | |
| Belgium | Research Site | Ekeren | |
| Belgium | Research Site | Enghien | |
| Belgium | Research Site | Erembodegem | |
| Belgium | Research Site | Essen | |
| Belgium | Research Site | Eupen | |
| Belgium | Research Site | Geel | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Genly | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Geraardsbergen | |
| Belgium | Research Site | Ghlin | |
| Belgium | Research Site | Gilly | |
| Belgium | Research Site | Gozée | |
| Belgium | Research Site | Gribomont | |
| Belgium | Research Site | Haaltert | |
| Belgium | Research Site | Halen | |
| Belgium | Research Site | Halle | |
| Belgium | Research Site | HAM | |
| Belgium | Research Site | Hannut | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Havinnes | |
| Belgium | Research Site | Havre | |
| Belgium | Research Site | Herent | |
| Belgium | Research Site | Herstal | |
| Belgium | Research Site | Herzele | |
| Belgium | Research Site | Hoboken | |
| Belgium | Research Site | Hooglede | |
| Belgium | Research Site | Houthalen-helchteren | |
| Belgium | Research Site | Incourt | |
| Belgium | Research Site | Jemappes | |
| Belgium | Research Site | Kapellen | |
| Belgium | Research Site | Knokke | |
| Belgium | Research Site | Kuringen | |
| Belgium | Research Site | La Hulpe | |
| Belgium | Research Site | La Louvière | |
| Belgium | Research Site | La Roche | |
| Belgium | Research Site | Laakdal | |
| Belgium | Research Site | Lanaken | |
| Belgium | Research Site | Lauwe | |
| Belgium | Research Site | Lessines | |
| Belgium | Research Site | Libramont | |
| Belgium | Research Site | Liege | |
| Belgium | Research Site | Lier | |
| Belgium | Research Site | Ligne | |
| Belgium | Research Site | Ligney | |
| Belgium | Research Site | Linkebeek | |
| Belgium | Research Site | Lo-reninge | |
| Belgium | Research Site | Louveigne | |
| Belgium | Research Site | Manage | |
| Belgium | Research Site | Marche | |
| Belgium | Research Site | Marchin | |
| Belgium | Research Site | Marchovelette | |
| Belgium | Research Site | Marloie | |
| Belgium | Research Site | Mechelen | |
| Belgium | Research Site | Merksem | |
| Belgium | Research Site | Merksplas | |
| Belgium | Research Site | Mettet | |
| Belgium | Research Site | Moerkerke | |
| Belgium | Research Site | MOL | |
| Belgium | Research Site | Moorlede | |
| Belgium | Research Site | Moorsel | |
| Belgium | Research Site | Mouscron | |
| Belgium | Research Site | Noorderwijk | |
| Belgium | Research Site | Olen | |
| Belgium | Research Site | Ooigem | |
| Belgium | Research Site | Oostende | |
| Belgium | Research Site | Oostrozebeke | |
| Belgium | Research Site | Oppuurs | |
| Belgium | Research Site | Outer | |
| Belgium | Research Site | Perk | |
| Belgium | Research Site | Pittem | |
| Belgium | Research Site | Poederlee | |
| Belgium | Research Site | Poelkapelle | |
| Belgium | Research Site | Quaregnon | |
| Belgium | Research Site | Rance | |
| Belgium | Research Site | Ransart | |
| Belgium | Research Site | Retie | |
| Belgium | Research Site | Retinne | |
| Belgium | Research Site | Roeselare | |
| Belgium | Research Site | Ronse | |
| Belgium | Research Site | Rotheux-rimiere | |
| Belgium | Research Site | Ruiselede | |
| Belgium | Research Site | Saint Vaast | |
| Belgium | Research Site | Saintes | |
| Belgium | Research Site | Saive | |
| Belgium | Research Site | Schilde | |
| Belgium | Research Site | Selayn | |
| Belgium | Research Site | Sint-lambrechts-herk | |
| Belgium | Research Site | Sint-niklaas | |
| Belgium | Research Site | Staden | |
| Belgium | Research Site | Steenokkerzeel | |
| Belgium | Research Site | Templeuve | |
| Belgium | Research Site | Tessenderlo | |
| Belgium | Research Site | Thuin | |
| Belgium | Research Site | Tielt | |
| Belgium | Research Site | Tubize | |
| Belgium | Research Site | Veurne | |
| Belgium | Research Site | Vosselaar | |
| Belgium | Research Site | Waasmunster | |
| Belgium | Research Site | Wanze | |
| Belgium | Research Site | Waremme | |
| Belgium | Research Site | Wasseiges | |
| Belgium | Research Site | Watervliet | |
| Belgium | Research Site | Wellin | |
| Belgium | Research Site | Wenduine | |
| Belgium | Research Site | Wervik | |
| Belgium | Research Site | Westrozebeke | |
| Belgium | Research Site | Wetteren | |
| Belgium | Research Site | Willebroek | |
| Belgium | Research Site | Wingene | |
| Belgium | Research Site | Zedelgem | |
| Belgium | Research Site | Zemst | |
| Belgium | Research Site | Zoersel | |
| Belgium | Research Site | Zonnebeke | |
| Belgium | Research Site | Zottegem | |
| Belgium | Research Site | Zwevegem | |
| Greece | Research Site | Agrinio | |
| Greece | Research Site | Alexandroupolis | |
| Greece | Research Site | Amaliada | |
| Greece | Research Site | Arta | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Chalkida | |
| Greece | Research Site | Crete | |
| Greece | Research Site | Drama | |
| Greece | Research Site | Edessa | |
| Greece | Research Site | Giannitsa | |
| Greece | Research Site | Grevena | |
| Greece | Research Site | Ioannina | |
| Greece | Research Site | Kastoria | |
| Greece | Research Site | Kavala | |
| Greece | Research Site | Kerkyra | |
| Greece | Research Site | Komotini | |
| Greece | Research Site | Kos | |
| Greece | Research Site | Kozani | |
| Greece | Research Site | Lakonia | |
| Greece | Research Site | Lamia | |
| Greece | Research Site | Larissa | |
| Greece | Research Site | Naousa | |
| Greece | Research Site | Patra | |
| Greece | Research Site | Peiraias | |
| Greece | Research Site | Rodos | |
| Greece | Research Site | Serres | |
| Greece | Research Site | Thermo | |
| Greece | Research Site | Thessaloniki | |
| Greece | Research Site | Volos | |
| Luxembourg | Research Site | Bertrange | |
| Luxembourg | Research Site | Bissen | |
| Luxembourg | Research Site | Bridel | |
| Luxembourg | Research Site | Diekierch | |
| Luxembourg | Research Site | Differdange | |
| Luxembourg | Research Site | Dudelange | |
| Luxembourg | Research Site | Esch-sur-alzette | |
| Luxembourg | Research Site | Ettelbruck | |
| Luxembourg | Research Site | Hollenfels | |
| Luxembourg | Research Site | Hosingen | |
| Luxembourg | Research Site | Kehlen | |
| Luxembourg | Research Site | Larochette | |
| Luxembourg | Research Site | Luxembourg | |
| Luxembourg | Research Site | Obercorn | |
| Luxembourg | Research Site | Redange/attert | |
| Luxembourg | Research Site | Rodange | |
| Luxembourg | Research Site | Rumelange | |
| Luxembourg | Research Site | Sanem | |
| Luxembourg | Research Site | Strassen | |
| Portugal | Research Site | Beja | |
| Portugal | Research Site | Elvas | |
| Portugal | Research Site | Faro | |
| Portugal | Research Site | Gaia | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Penafiel | |
| Portugal | Research Site | Porto | |
| Portugal | Research Site | Santarém | |
| Portugal | Research Site | Torres Novas | |
| Portugal | Research Site | Torres Vedras | |
| Portugal | Research Site | Viana do Castelo | |
| Spain | Research Site | Badalona | Barcelona |
| Spain | Research Site | Barcelona | Barceloan |
| Spain | Research Site | Begonte | Lugo |
| Spain | Research Site | Guitiriz | Lugo |
| Spain | Research Site | La Coruna | |
| Spain | Research Site | Letux | Zaragoza |
| Spain | Research Site | Lugo | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Manresa | Barcelona |
| Spain | Research Site | Mombuey | Zamora |
| Spain | Research Site | Monistrol de Montserrat | Barcelona |
| Spain | Research Site | Ribadesella | Asturias |
| Spain | Research Site | San Fernando de Henares | Madrid |
| Spain | Research Site | Sant Fruitos de Bages | Barceloan |
| Spain | Research Site | Tabara | Zamora |
| Spain | Research Site | Valencia | |
| Spain | Research Site | Villar del Arzobispo | Valencia |
| Spain | Research Site | Viveiro | Lugo |
| Spain | Research Site | Zaragoza | |
| United Kingdom | Research Site | Aldershot | |
| United Kingdom | Research Site | Atherstone | |
| United Kingdom | Research Site | Belfast | |
| United Kingdom | Research Site | Blackburn | |
| United Kingdom | Research Site | Bolton | |
| United Kingdom | Research Site | Bradford | |
| United Kingdom | Research Site | Cardiff | |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Crawley | |
| United Kingdom | Research Site | Crowthorne | |
| United Kingdom | Research Site | Doncaster | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Great Sutton | |
| United Kingdom | Research Site | Harrow | |
| United Kingdom | Research Site | High Valleyfield | |
| United Kingdom | Research Site | Leamington Spa | |
| United Kingdom | Research Site | Peterborough | |
| United Kingdom | Research Site | Slough | |
| United Kingdom | Research Site | Sneinton | |
| United Kingdom | Research Site | Stevenage | |
| United Kingdom | Research Site | Sunbury on Thames | |
| United Kingdom | Research Site | Watford | |
| United Kingdom | Research Site | Wellingborough | |
| United Kingdom | Research Site | Westbury |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Belgium, Greece, Luxembourg, Portugal, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c, LDL-cholesterol, Systolic Blood Pressure | Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1) | ||
| Secondary | Glycaemia, Triglycerides, Total and HDL-Cholesterol, Diastolic Blood Pressure, Waist circumference, Smoking habits, Microalbuminuria, Body Mass Index, Physical activity (Rating scale and step counter), Degree of ophthalmic control and dietary advice | Visit 1Visit 2 (after approximately 4 months after visit 1)Visit 3 (after approximately 8 months after visit 1)Visit 4 (after approximately 12 months after visit 1) |
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