Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey (PANORAMA)

April 26, 2010 updated by: AstraZeneca

The present European survey seeks to assess quality of life and satisfaction with treatment in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. It will also provide relevant information on other important aspects such as the level of correlation of objective measures such as HbA1c with health status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. The study will entail a single patient visit. Patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review & an HbA1c test, will allow patient, disease and treatment variables to be collected. An HbA1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.

Study Overview

Status

Completed

Conditions

Diabetes

Study Type

Observational

Enrollment (Actual)

5926

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Antibes, France
    - Research Site
  - Athies, France
    - Research Site
  - Audruicq, France
    - Research Site
  - Auxerre, France
    - Research Site
  - Baigneux les Juifs, France
    - Research Site
  - Baume les Dames, France
    - Research Site
  - Beaumont sur leze, France
    - Research Site
  - Beaurepaire, France
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  - Beauvais, France
    - Research Site
  - Berat, France
    - Research Site
  - Bettacourt la Ferree, France
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  - Beziers, France
    - Research Site
  - Bezons, France
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  - Blois, France
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  - Boulogne sur Gesse, France
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  - Bresles, France
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  - Brest Cedex 3, France
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  - Breteuil Sur Iton, France
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  - Bruere Allichamps, France
    - Research Site
  - Bulles, France
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  - Burry, France
    - Research Site
  - Cany Barville, France
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  - Capdenac Gare, France
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  - Cappelle Brouck, France
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  - Carquefou, France
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  - Carresse Cassaber, France
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  - Carros, France
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  - Celles sur Plaine, France
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  - Chabons, France
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  - Champagnole, France
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  - Champigny Sur Marne, France
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  - Chanmpdeniers St Denis, France
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  - Chartrettes, France
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  - Chatillon sur Colmont, France
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  - Chauvigny, France
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  - Clairac, France
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  - Clichy, France
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  - Comps, France
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  - Concarneu, France
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  - Courbevoie, France
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  - Courpiere, France
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  - Coutances, France
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  - Coutouvre, France
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  - Dambach La Ville, France
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  - Dieulouard, France
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  - Digoin, France
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  - Donges, France
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  - Douchy Les Mines, France
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  - Drap, France
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  - Equeurdreville Hainneville, France
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  - Escaudain, France
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  - Faverges, France
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  - Fenouillet, France
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  - Firmi, France
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  - Francoville la Garenne, France
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  - Fruges, France
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  - Gelles, France
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  - Gondrecourt le Chateau, France
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  - Guitalens L' Albarede, France
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  - Hanvec, France
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  - Houilles, France
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  - Hyeres, France
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  - Ivry Sur Seine, France
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  - Jussey, France
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  - L' Hay Les Roses, France
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  - La Courneuve, France
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  - La Crau, France
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  - La Ferte st Aubin, France
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  - La Mulatiere, France
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  - La Tranche sur Mer, France
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  - Lamagistere, France
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  - Lanouaille, France
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  - Laroquebrou, France
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  - Lathus st Remy, France
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  - Le Cannet, France
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  - Le Grand Lemps, France
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  - Le Havre, France
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  - Le Monastier sur Gazeille, France
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  - Le Nouvion en Thierache, France
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  - Le Pertre, France
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  - Le Plessis Trevise, France
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  - Le Pontet, France
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  - Les Mees, France
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  - Leyme, France
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  - Lezignan Corbieres, France
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  - Locmiquelic, France
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  - Luneray, France
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  - Lyon, France
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  - Magland, France
    - Research Site
  - Maintenon, France
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  - Mantes La Ville, France
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  - Marcq en Baroeul, France
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  - Marles les Mines, France
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  - Marseille, France
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  - Mauleon Soule, France
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  - Mayet, France
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  - Meximieux, France
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  - Mezzavia, France
    - Research Site
  - Miramas, France
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  - Monce en Berlin, France
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  - Montelimar, France
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  - Montfort en Chalosse, France
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  - Montoire Sur le Loir, France
    - Research Site
  - Montreuil, France
    - Research Site
  - Monts sur Guesnes, France
    - Research Site
  - Mussidan, France
    - Research Site
  - Narbonne, France
    - Research Site
  - Neuilly Les Dijon, France
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  - Nice, France
    - Research Site
  - Niederschaeffolsheim, France
    - Research Site
  - Noisy Le Sec, France
    - Research Site
  - Nordausques, France
    - Research Site
  - Nouatre, France
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  - Oberhausbergen, France
    - Research Site
  - Orchies, France
    - Research Site
  - Orlienas, France
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  - Ormes, France
    - Research Site
  - Pantin, France
    - Research Site
  - Paris, France
    - Research Site
  - Pau, France
    - Research Site
  - Pauillac, France
    - Research Site
  - Pernes les Fontaines, France
    - Research Site
  - Pibrac, France
    - Research Site
  - Pierrepont sur Avre, France
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  - Pitgam, France
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  - Plancoet, France
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  - Pleneuf val Andre, France
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  - Plouvorn, France
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  - Pornic, France
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  - Port La Nouvelle, France
    - Research Site
  - Pradines, France
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  - Puilley Les Vignes, France
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  - Puttelange aux Lacs, France
    - Research Site
  - Quessoy, France
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  - Quiberon, France
    - Research Site
  - Quimper, France
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  - Rambervillers, France
    - Research Site
  - Renaze, France
    - Research Site
  - Richemont, France
    - Research Site
  - Robion, France
    - Research Site
  - Romainville, France
    - Research Site
  - Rombas, France
    - Research Site
  - Romorantin Lanthenay, France
    - Research Site
  - Salles, France
    - Research Site
  - Salome, France
    - Research Site
  - Sassenage, France
    - Research Site
  - Sault les Rethel, France
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  - Soissons, France
    - Research Site
  - Soisy sur Ecole, France
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  - Soyaux, France
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  - St Andre de Sangonis, France
    - Research Site
  - St Aubin des Chateaux, France
    - Research Site
  - St Bonnet le Chateau, France
    - Research Site
  - St Jean de Maurienne, France
    - Research Site
  - St Laurent d Aigouze, France
    - Research Site
  - St Martin des Champs, France
    - Research Site
  - St Saens, France
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  - St Thuriau, France
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  - St Yorre, France
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  - Ste Menehould, France
    - Research Site
  - Strasbourg, France
    - Research Site
  - Thann, France
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  - Thure, France
    - Research Site
  - Toufflers, France
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  - Toulon, France
    - Research Site
  - Tourcoing, France
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  - Troyes, France
    - Research Site
  - Uzes, France
    - Research Site
  - Vailly Sur Aisne, France
    - Research Site
  - Valenton, France
    - Research Site
  - Valras Plage, France
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  - Vaugneray, France
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  - Villefagnan, France
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  - Villejuif, France
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  - Villeurbanne, France
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  - Vitry Le Francois, France
    - Research Site
Germany
- - Aachen, Germany
    - Research Site
  - Alsdorf, Germany
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  - Ampfing, Germany
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  - Aschersleben, Germany
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  - Augsburg, Germany
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  - Bad Freienwalde, Germany
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  - Bad Staffelstein, Germany
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  - Berlin, Germany
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  - Biberbach, Germany
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  - Bonn, Germany
    - Research Site
  - Coburg, Germany
    - Research Site
  - Duisburg, Germany
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  - Edenkoben, Germany
    - Research Site
  - Erfurt, Germany
    - Research Site
  - Eschweiler, Germany
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  - Essen, Germany
    - Research Site
  - Frechen, Germany
    - Research Site
  - Fuchsstadt, Germany
    - Research Site
  - Fulda, Germany
    - Research Site
  - G�ntersleben, Germany
    - Research Site
  - Hamburg, Germany
    - Research Site
  - Heinsberg, Germany
    - Research Site
  - Holzkirchen, Germany
    - Research Site
  - Homburg, Germany
    - Research Site
  - Iserlohn, Germany
    - Research Site
  - Kaisersesch, Germany
    - Research Site
  - Kalkar, Germany
    - Research Site
  - Kehl, Germany
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  - Kirchheim, Germany
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  - Klingenberg, Germany
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  - Ludwigshafen, Germany
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  - Magdeburg, Germany
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  - Marpingen, Germany
    - Research Site
  - Moers, Germany
    - Research Site
  - Munchen, Germany
    - Research Site
  - Nurnberg, Germany
    - Research Site
  - Oberursel, Germany
    - Research Site
  - Pretzfeld, Germany
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  - Reit im Winkl, Germany
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  - Rimbach, Germany
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  - Sand, Germany
    - Research Site
  - Schwaig, Germany
    - Research Site
  - Sinntal, Germany
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  - Sonthofen, Germany
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  - Westerkappeln, Germany
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  - Wiesbaden, Germany
    - Research Site
  - Zweibrucken, Germany
    - Research Site
  - Zwenkau, Germany
    - Research Site
Greece
- - Athens, Greece
    - Research Site
Ireland
- - Belfast, Ireland
    - Research Site
  - Co. ANRTIM, Ireland
    - Research Site
Italy
- - Latina, Italy
    - Research Site
  - Rome, Italy
    - Research Site
  - Viterbo, Italy
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- Bari
  - Andria, Bari, Italy
    - Research Site
Netherlands
- Drenthe
  - Beilen, Drenthe, Netherlands
    - Research Site
  - Coevorden, Drenthe, Netherlands
    - Research Site
  - Zwartemeer, Drenthe, Netherlands
    - Research Site
- Flevoland
  - Almere, Flevoland, Netherlands
    - Research Site
- Friesland
  - Drachten, Friesland, Netherlands
    - Research Site
- Gelderland
  - Lichtenvoorde, Gelderland, Netherlands
    - Research Site
  - Nijmegen, Gelderland, Netherlands
    - Research Site
- Groningen
  - Onstwedde, Groningen, Netherlands
    - Research Site
- Limburg
  - Maastricht, Limburg, Netherlands
    - Research Site
  - Vlodorp, Limburg, Netherlands
    - Research Site
- Noord-Braband
  - Beek en Donk, Noord-Braband, Netherlands
    - Research Site
  - Den Bosch, Noord-Braband, Netherlands
    - Research Site
  - Etten-Leur, Noord-Braband, Netherlands
    - Research Site
  - Lieshout, Noord-Braband, Netherlands
    - Research Site
  - Schijndel, Noord-Braband, Netherlands
    - Research Site
  - Soerendonk, Noord-Braband, Netherlands
    - Research Site
- Noord-Holland
  - Edam, Noord-Holland, Netherlands
    - Research Site
  - Hoogwoud, Noord-Holland, Netherlands
    - Research Site
  - Huizen, Noord-Holland, Netherlands
    - Research Site
  - Volendam, Noord-Holland, Netherlands
    - Research Site
- Overijssel
  - Ermelo, Overijssel, Netherlands
    - Research Site
  - Heeten, Overijssel, Netherlands
    - Research Site
  - Hengelo, Overijssel, Netherlands
    - Research Site
  - Nijverdal, Overijssel, Netherlands
    - Research Site
  - Tubbergen, Overijssel, Netherlands
    - Research Site
- Utrecht
  - Amersfoort, Utrecht, Netherlands
    - Research Site
- Zeeland
  - Poortvliet, Zeeland, Netherlands
    - Research Site
- Zuid-Holland
  - Bennebroek, Zuid-Holland, Netherlands
    - Research Site
  - Den Haag, Zuid-Holland, Netherlands
    - Research Site
  - Dordrecht, Zuid-Holland, Netherlands
    - Research Site
  - Lisse, Zuid-Holland, Netherlands
    - Research Site
  - Rijswijk, Zuid-Holland, Netherlands
    - Research Site
  - Roelofarendsveen, Zuid-Holland, Netherlands
    - Research Site
  - Rotterdam, Zuid-Holland, Netherlands
    - Research Site
  - Spijkernisse, Zuid-Holland, Netherlands
    - Research Site
  - Woerden, Zuid-Holland, Netherlands
    - Research Site
Spain
- - Madrid, Spain
    - Research Site
- Andalucia
  - Cadiz, Andalucia, Spain
    - Research Site
- Cantabria
  - Santander, Cantabria, Spain
    - Research Site
- Castilla Y Leon
  - Burgos, Castilla Y Leon, Spain
    - Research Site
- Cataluna
  - Manresa, Cataluna, Spain
    - Research Site
- Catalu�a
  - Barcelona, Catalu�a, Spain
    - Research Site
- Comunidad Valenciana
  - Elche, Comunidad Valenciana, Spain
    - Research Site
- Galicia
  - Pontevedra, Galicia, Spain
    - Research Site
- Las Palmas De Gran Canaria
  - Gran Canaria, Las Palmas De Gran Canaria, Spain
    - Research Site
- Madrid
  - Coslada, Madrid, Spain
    - Research Site
  - Fuenlabrada, Madrid, Spain
    - Research Site
United Kingdom
- - Bath, United Kingdom
    - Research Site
  - Bedford, United Kingdom
    - Research Site
  - Birmingham, United Kingdom
    - Research Site
  - Blackburn, United Kingdom
    - Research Site
  - Blackpool, United Kingdom
    - Research Site
  - Bristol, United Kingdom
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  - Bury St Edmunds, United Kingdom
    - Research Site
  - Cambridge, United Kingdom
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  - Canterbury, United Kingdom
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  - Cardiff, United Kingdom
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  - Cornwall, United Kingdom
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  - Coventry, United Kingdom
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  - Darlington, United Kingdom
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  - Glasgow, United Kingdom
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  - Guildford, United Kingdom
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  - London, United Kingdom
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  - Manchester, United Kingdom
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  - Newcastle, United Kingdom
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  - Penzance, United Kingdom
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  - Plymouth, United Kingdom
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  - Reading, United Kingdom
    - Research Site
  - Salisbury, United Kingdom
    - Research Site
  - Sheffield, United Kingdom
    - Research Site
  - St Albans, United Kingdom
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

To be recruited in Primary Care Centres mainly, but hospitals will be allowed in some countries

Description

Inclusion Criteria:

With T2DM, diagnosed at least 1 year prior to entry in the study
Currently treated with diet, OAD(s) and/or insulin with no change in the type of OAD(s) or insulin in the previous three months

Exclusion Criteria:

Type 1 diabetes and/or history of diabetic ketoacidosis
Secondary diabetes (including disease of the exocrine pancreas, endocrinopathies or drug-induced)
Treatment with systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids is allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort Group / Cohort A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
1 Patients ³ 40 years old, with T2DM diagnosed and followed up in the participating site at least 1 year prior to entry in the study, treated with diet, OADs and/or insulin for at least the past three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D Time Frame: Cross-sectional and retrospective	Cross-sectional and retrospective

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease-related variables: Years with diabetes, use of SMBG and frequency of monitoring, Hypoglycaemic episodes, Past Medical History, Macro and micro-vascular complications Time Frame: Retrospective (previous 24 months)	Retrospective (previous 24 months)
Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications) Time Frame: Retrospective (previous 24 months)	Retrospective (previous 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Angeles Porta, Medical Department.AstraZeneca Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 27, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NIS-CEU-DUM-2008/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.