DiabetesPANORAMANCT00916513
Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey
An observational study of Diabetes, run by AstraZeneca at 302 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes
- How many people
- 5,926 participants
- Where
- 302 sitesin 8 countries
- Study dates
- May 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To be recruited in Primary Care Centres mainly, but hospitals will be allowed in some countries
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
302 sites in 8 countries.
302 sites in 8 countries
France176 sites
Research Site
Antibes
Research Site
Athies
Research Site
Audruicq
Research Site
Auxerre
Research Site
Baigneux-les-Juifs
Research Site
Baume-les-Dames
Research Site
Beaumont-sur-Lèze
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Beaurepaire
Research Site
Beauvais
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Bérat
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Bettacourt La Ferree
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Béziers
Research Site
Bezons
Research Site
Blois
Research Site
Boulogne-sur-Gesse
Research Site
Bresles
Research Site
Brest
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Breteuil
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Bruère-Allichamps
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Bulles
Research Site
Burry
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Cany-Barville
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Capdenac-Gare
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Cappelle-Brouck
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Carquefou
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Carresse-Cassaber
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Carros
Research Site
Celles-sur-Plaine
Research Site
Châbons
Research Site
Champagnole
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Champigny-sur-Marne
Research Site
Chanmpdeniers Saint Denis
Research Site
Chartrettes
Research Site
Châtillon-sur-Colmont
Research Site
Chauvigny
Research Site
Clairac
Research Site
Clichy
Research Site
Comps
Research Site
Concarneu
Research Site
Courbevoie
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Courpière
Research Site
Coutances
Research Site
Coutouvre
Research Site
Dambach-la-Ville
Research Site
Dieulouard
Research Site
Digoin
Research Site
Donges
Research Site
Douchy-les-Mines
Research Site
Drap
Research Site
Équeurdreville-Hainneville
Research Site
Escaudain
Research Site
Faverges
Research Site
Fenouillet
Research Site
Firmi
Research Site
Francoville La Garenne
Research Site
Fruges
Research Site
Gelles
Research Site
Gondrecourt-le-Château
Research Site
Guitalens-L'Albarède
Research Site
Hanvec
Research Site
Houilles
Research Site
Hyères
Research Site
Ivry-sur-Seine
Research Site
Jussey
Research Site
L'Haÿ-les-Roses
Research Site
La Courneuve
Research Site
La Crau
Research Site
La Ferté-Saint-Aubin
Research Site
La Mulatière
Research Site
La Tranche-sur-Mer
Research Site
Lamagistère
Research Site
Lanouaille
Research Site
Laroquebrou
Research Site
Lathus-Saint-Rémy
Research Site
Le Cannet
Research Site
Le Grand-Lemps
Research Site
Le Havre
Research Site
Le Monastier-sur-Gazeille
Research Site
Le Nouvion-en-Thiérache
Research Site
Le Pertre
Research Site
Le Plessis-Trévise
Research Site
Le Pontet
Research Site
Les Mées
Research Site
Leyme
Research Site
Lézignan-Corbières
Research Site
Locmiquélic
Research Site
Luneray
Research Site
Lyon
Research Site
Magland
Research Site
Maintenon
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Mantes-la-Ville
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Marcq-en-Barœul
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Marles-les-Mines
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Marseille
Research Site
Mauléon-Licharre
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Mayet
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Meximieux
Research Site
Mezzavia
Research Site
Miramas
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Monce En Berlin
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Montélimar
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Montfort-en-Chalosse
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Montoire-sur-le-Loir
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Montreuil
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Monts-sur-Guesnes
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Mussidan
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Narbonne
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Neuilly-lès-Dijon
Research Site
Nice
Research Site
Niederschaeffolsheim
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Noisy-le-Sec
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Nordausques
Research Site
Nouâtre
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Oberhausbergen
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Orchies
Research Site
Orliénas
Research Site
Ormes
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Pantin
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Paris
Research Site
Pau
Research Site
Pauillac
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Pernes-les-Fontaines
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Pibrac
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Pierrepont-sur-Avre
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Pitgam
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Plancoët
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Pléneuf-Val-André
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Plouvorn
Research Site
Pornic
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Port-La Nouvelle
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Pradines
Research Site
Puilley Les Vignes
Research Site
Puttelange-aux-Lacs
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Quessoy
Research Site
Quiberon
Research Site
Quimper
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Rambervillers
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Renazé
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Richemont
Research Site
Robion
Research Site
Romainville
Research Site
Rombas
Research Site
Romorantin-Lanthenay
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Saint-André-de-Sangonis
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Saint-Aubin-des-Châteaux
Research Site
Saint-Bonnet-le-Château
Research Site
Saint-Jean-de-Maurienne
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Saint-Laurent-d'Aigouze
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Saint-Martin-des-Champs
Research Site
Saint-Saëns
Research Site
Saint-Thuriau
Research Site
Saint-Yorre
Research Site
Salles
Research Site
Salomé
Research Site
Sassenage
Research Site
Sault-lès-Rethel
Research Site
Soissons
Research Site
Soisy-sur-École
Research Site
Soyaux
Research Site
Ste Menehould
Research Site
Strasbourg
Research Site
Thann
Research Site
Thuré
Research Site
Toufflers
Research Site
Toulon
Research Site
Tourcoing
Research Site
Troyes
Research Site
Uzès
Research Site
Vailly-sur-Aisne
Research Site
Valenton
Research Site
Valras-Plage
Research Site
Vaugneray
Research Site
Villefagnan
Research Site
Villejuif
Research Site
Villeurbanne
Research Site
Vitry-le-François
Germany48 sites
Research Site
Aachen
Research Site
Alsdorf
Research Site
Ampfing
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Aschersleben
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Augsburg
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Bad Freienwalde
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Bad Staffelstein
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Berlin
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Biberbach
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Bonn
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Coburg
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Duisburg
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Edenkoben
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Erfurt
Research Site
Eschweiler
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Essen
Research Site
Frechen
Research Site
Fuchsstadt
Research Site
Fulda
Research Site
G�ntersleben
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Hamburg
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Heinsberg
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Holzkirchen
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Homburg
Research Site
Iserlohn
Research Site
Kaisersesch
Research Site
Kalkar
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Kehl
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Kirchheim
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Klingenberg
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Ludwigshafen
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Magdeburg
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Marpingen
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Moers
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München
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Nuremberg
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Oberursel
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Pretzfeld
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Reit im Winkl
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Rimbach
Research Site
Sand
Research Site
Schwaig
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Sinntal
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Sonthofen
Research Site
Westerkappeln
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Wiesbaden
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Zweibrücken
Research Site
Zwenkau
Netherlands36 sites
Research Site
's-Hertogenbosch, Noord-Braband
Research Site
Almere Stad, Flevoland
Research Site
Amersfoort, Utrecht
Research Site
Beek en Donk, Noord-Braband
Research Site
Beilen, Drenthe
Research Site
Bennebroek, South Holland
Research Site
Coevorden, Drenthe
Research Site
Dordrecht, South Holland
Research Site
Drachten, Provincie Friesland
Research Site
Edam, North Holland
Research Site
Ermelo, Overijssel
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Etten-Leur, Noord-Braband
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Heeten, Overijssel
Research Site
Hengelo, Overijssel
Research Site
Hoogwoud, North Holland
Research Site
Huizen, North Holland
Research Site
Lichtenvoorde, Gelderland
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Lieshout, Noord-Braband
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Lisse, South Holland
Research Site
Maastricht, Limburg
Research Site
Nijmegen, Gelderland
Research Site
Nijverdal, Overijssel
Research Site
Onstwedde, Provincie Groningen
Research Site
Poortvliet, Zeeland
Research Site
Rijswijk, South Holland
Research Site
Roelofarendsveen, South Holland
Research Site
Rotterdam, South Holland
Research Site
Schijndel, Noord-Braband
Research Site
Soerendonk, Noord-Braband
Research Site
Spijkernisse, South Holland
Research Site
The Hague, South Holland
Research Site
Tubbergen, Overijssel
Research Site
Vlodorp, Limburg
Research Site
Volendam, North Holland
Research Site
Woerden, South Holland
Research Site
Zwartemeer, Drenthe
United Kingdom24 sites
Research Site
Bath
Research Site
Bedford
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Birmingham
Research Site
Blackburn
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Blackpool
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Bristol
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Bury St Edmunds
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Cambridge
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Canterbury
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Cardiff
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Cornwall
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Coventry
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Darlington
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Glasgow
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Guildford
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London
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Manchester
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Newcastle
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Penzance
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Plymouth
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Reading
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Salisbury
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Sheffield
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St Albans
Spain11 sites
Research Site
Barcelona, Catalu�a
Research Site
Burgos, Castille and León
Research Site
Cadiz, Andalusia
Research Site
Coslada, Madrid
Research Site
Elche, Valencia
Research Site
Fuenlabrada, Madrid
Research Site
Gran Canaria, Las Palmas de Gran Canaria
Research Site
Madrid, Madrid
Research Site
Manresa, Catalonia
Research Site
Pontevedra, Galicia
Research Site
Santander, Cantabria
Italy4 sites
Research Site
Andria, Bari
Research Site
Latina
Research Site
Rome
Research Site
Viterbo
About this study
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.
- Conditions
- Diabetes
- Keywords
- Diabetes, Treatment Satisfaction, Quality of Life, HbA1c levels and goals, Healthcare resources consumption
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D
Measured: Cross-sectional and retrospective
Secondary outcomes (2)
Disease-related variables: Years with diabetes, use of SMBG and frequency of monitoring, Hypoglycaemic episodes, Past Medical History, Macro and micro-vascular complications
Measured: Retrospective (previous 24 months)
Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications)
Measured: Retrospective (previous 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 5,926 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Angeles Porta, Study director, Medical Department.AstraZeneca Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916513
- Sponsor's protocol ID
- NIS-CEU-DUM-2008/2
- Acronym
- PANORAMA
- Status last verified
- Apr 2010
- First submitted
- 5 Jun 2009
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradley C, Eschwege E, de Pablos-Velasco P, Parhofer KG, Simon D, Vandenberghe H, Gonder-Frederick L. Predictors of Quality of Life and Other Patient-Reported Outcomes in the PANORAMA Multinational Study of People With Type 2 Diabetes. Diabetes Care. 2018 Feb;41(2):267-276. doi: 10.2337/dc16-2655. Epub 2017 Nov 28.
PubMed 29183910Simon D, de Pablos-Velasco P, Parhofer KG, Gonder-Frederick L, Duprat Lomon I, Vandenberghe H, Eschwege E, Bradley C. Hypoglycaemic episodes in patients with type 2 diabetes--risk factors and associations with patient-reported outcomes: The PANORAMA Study. Diabetes Metab. 2015 Dec;41(6):470-9. doi: 10.1016/j.diabet.2015.08.007. Epub 2015 Oct 9.
PubMed 26455870de Pablos-Velasco P, Parhofer KG, Bradley C, Eschwege E, Gonder-Frederick L, Maheux P, Wood I, Simon D. Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study. Clin Endocrinol (Oxf). 2014 Jan;80(1):47-56. doi: 10.1111/cen.12119. Epub 2013 May 6.
PubMed 23194193Bradley C, de Pablos-Velasco P, Parhofer KG, Eschwege E, Gonder-Frederick L, Simon D. PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus--study design. Prim Care Diabetes. 2011 Dec;5(4):231-9. doi: 10.1016/j.pcd.2011.04.004. Epub 2011 Jul 14.
PubMed 21752743
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey
- ClinicalTrials.gov ID
- NCT00916513
- Acronym / sponsor ID
- PANORAMA / NIS-CEU-DUM-2008/2
- Conditions
- Diabetes
- Keywords
- Diabetes, Treatment Satisfaction, Quality of Life, HbA1c levels and goals, Healthcare resources consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,926 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To be recruited in Primary Care Centres mainly, but hospitals will be allowed in some countries
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D
Time frame: Cross-sectional and retrospective
2 secondary outcomes
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)
Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications)
Time frame: Retrospective (previous 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
- Derived from this study: PubMed 29183910Bradley C, Eschwege E, de Pablos-Velasco P, Parhofer KG, Simon D, Vandenberghe H, Gonder-Frederick L. Predictors of Quality of Life and Other Patient-Reported Outcomes in the PANORAMA Multinational Study of People With Type 2 Diabetes. Diabetes Care. 2018 Feb;41(2):267-276. doi: 10.2337/dc16-2655. Epub 2017 Nov 28.
- Derived from this study: PubMed 26455870Simon D, de Pablos-Velasco P, Parhofer KG, Gonder-Frederick L, Duprat Lomon I, Vandenberghe H, Eschwege E, Bradley C. Hypoglycaemic episodes in patients with type 2 diabetes--risk factors and associations with patient-reported outcomes: The PANORAMA Study. Diabetes Metab. 2015 Dec;41(6):470-9. doi: 10.1016/j.diabet.2015.08.007. Epub 2015 Oct 9.
- Derived from this study: PubMed 23194193de Pablos-Velasco P, Parhofer KG, Bradley C, Eschwege E, Gonder-Frederick L, Maheux P, Wood I, Simon D. Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study. Clin Endocrinol (Oxf). 2014 Jan;80(1):47-56. doi: 10.1111/cen.12119. Epub 2013 May 6.
- Derived from this study: PubMed 21752743Bradley C, de Pablos-Velasco P, Parhofer KG, Eschwege E, Gonder-Frederick L, Simon D. PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus--study design. Prim Care Diabetes. 2011 Dec;5(4):231-9. doi: 10.1016/j.pcd.2011.04.004. Epub 2011 Jul 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angeles Porta study director
Medical Department.AstraZeneca Spain
302 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by AstraZeneca at 302 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 302 sites in France, Germany, Netherlands, United Kingdom, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D (time frame: Cross-sectional and retrospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916513, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2010.