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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00916513
Other study ID # NIS-CEU-DUM-2008/2
Secondary ID
Status Completed
Phase N/A
First received June 5, 2009
Last updated April 26, 2010
Start date May 2009
Est. completion date March 2010

Study information

Verified date April 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review BoardGermany: Ethics CommissionGreece: Ethics CommitteeGreece: Ministry of Health and WelfareItaly: Ethics CommitteeSpain: Ethics CommitteeTurkey: Ethics CommitteeUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 5926
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D Cross-sectional and retrospective No
Secondary Disease-related variables: Years with diabetes, use of SMBG and frequency of monitoring, Hypoglycaemic episodes, Past Medical History, Macro and micro-vascular complications Retrospective (previous 24 months) No
Secondary Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications) Retrospective (previous 24 months) No
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