The online version of this article (doi:10.1186/1475-2840-11-148) contains supplementary material, which is available to authorized users.
Anselm K Gitt (AKG), Roland E. Schmieder (RES), Peter Bramlage (PB), and Diethelm Tschöpe (DT) have received research support and honoraria for lectures from a number of pharmaceutical companies producing anti-diabetic drugs including Novartis the sponsor of this study. Eve Duetting (ED) is employee of the sponsor. Steffen Schneider (StS) has no potential conflict of interest to disclose.
AKG, ED, RES and DT designed the registry. StS is responsible for the analysis of data. PB drafted the manuscript based on the protocol and all other authors revised the article for important intellectual content. All authors have finally approved the version to be published.
Patients with type 2 diabetes have 2–4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD.
DIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1) individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2) individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE) and the rate of hospitalizations are the most important.
The registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti-diabetic and anti-hypertensive drugs in clinical trials and their real world balance of effectiveness and safety.
Zomer E, Liew D, Owen A, Magliano DJ, Ademi Z, Reid CM: Cardiovascular risk prediction in a population with the metabolic syndrome: Framingham vs. UKPDS algorithms. Eur J Prev Cardiol. 2012, 10.1177/2047487312449307. (published ahead of print)
The Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993, 329 (14): 977-986. CrossRef
UKPDS: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998, 352 (9131): 837-853. CrossRef
Ray KK, Seshasai SR, Wijesuriya S, Sivakumaran R, Nethercott S, Preiss D, Erqou S, Sattar N: Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009, 373 (9677): 1765-1772. 10.1016/S0140-6736(09)60697-8. CrossRefPubMed
Adler AI, Stratton IM, Neil HA, Yudkin JS, Matthews DR, Cull CA, Wright AD, Turner RC, Holman RR: Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000, 321 (7258): 412-419. 10.1136/bmj.321.7258.412. PubMedCentralCrossRefPubMed
Gaede P, Valentine WJ, Palmer AJ, Tucker DM, Lammert M, Parving HH, Pedersen O: Cost-effectiveness of intensified versus conventional multifactorial intervention in type 2 diabetes: results and projections from the Steno-2 study. Diabetes Care. 2008, 31 (8): 1510-1515. 10.2337/dc07-2452. PubMedCentralCrossRefPubMed
Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clement D, Coca A, Dominiczak A, et al: Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009, 18 (6): 308-347. 10.3109/08037050903450468. CrossRefPubMed
Matthaei S, Bierwirth R, Fritsche A, Gallwitz B, Häring H-U, Joost H-G, Kellerer M, Kloos C, Kunt T, Nauck M, et al: [Treatment of type-2 diabetes mellitus]. Diabetologie. 2011, 6 (Suppl. 2): S131-S136. CrossRef
Ferrannini E, Fonseca V, Zinman B, Matthews D, Ahren B, Byiers S, Shao Q, Dejager S: Fifty-two-week efficacy and safety of vildagliptin vs. glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. Diabetes Obes Metab. 2009, 11 (2): 157-166. 10.1111/j.1463-1326.2008.00994.x. CrossRefPubMed
Matthews DR, Dejager S, Ahren B, Fonseca V, Ferrannini E, Couturier A, Foley JE, Zinman B: Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. Diabetes Obes Metab. 2010, 12 (9): 780-789. 10.1111/j.1463-1326.2010.01233.x. CrossRefPubMed
Filozof C, Gautier JF: A comparison of efficacy and safety of vildagliptin and gliclazide in combination with metformin in patients with Type 2 diabetes inadequately controlled with metformin alone: a 52-week, randomized study. Diabet Med. 2010, 27 (3): 318-326. 10.1111/j.1464-5491.2010.02938.x. CrossRefPubMed
Goke B, Gallwitz B, Eriksson J, Hellqvist A, Gause-Nilsson I: Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial. Int J Clin Pract. 2010, 64 (12): 1619-1631. 10.1111/j.1742-1241.2010.02510.x. CrossRefPubMed
Forst T, Uhlig-Laske B, Ring A, Graefe-Mody U, Friedrich C, Herbach K, Woerle HJ, Dugi KA: Linagliptin (BI 1356), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled Type 2 diabetes. Diabet Med. 2010, 27 (12): 1409-1419. 10.1111/j.1464-5491.2010.03131.x. CrossRefPubMed
Rizzo MR, Barbieri M, Marfella R, Paolisso G: Reduction of Oxidative Stress and Inflammation by Blunting Daily Acute Glucose Fluctuations in Patients With Type 2 Diabetes: Role of dipeptidyl peptidase-IV inhibition. Diabetes Care. 2012, 35 (10): 2076-2082. 10.2337/dc12-0199. PubMedCentralCrossRefPubMed
Shishido T, Konta T, Nishiyama S, Miyashita T, Miyamoto T, Takasaki S, Nitobe J, Watanabe T, Takeishi Y, Kubota I: Suppressive effects of valsartan on microalbuminuria and CRP in patients with metabolic syndrome (Val-Mets). Clin Exp Hypertens. 2011, 33 (2): 117-123. 10.3109/10641963.2010.531837. CrossRefPubMed
Stolar MW, Hoogwerf BJ, Gorshow SM, Boyle PJ, Wales DO: Managing type 2 diabetes: going beyond glycemic control. J Manag Care Pharm. 2008, 14 (5 Suppl B): s2-s19. PubMed
Braga MF, Casanova A, Teoh H, Gerstein HC, Fitchett DH, Honos G, McFarlane PA, Ur E, Yale JF, Langer A, et al: Poor achievement of guidelines-recommended targets in type 2 diabetes: findings from a contemporary prospective cohort study. Int J Clin Pract. 2012, 66 (5): 457-464. 10.1111/j.1742-1241.2012.02894.x. CrossRefPubMed
Ruckert IM, Schunk M, Holle R, Schipf S, Volzke H, Kluttig A, Greiser KH, Berger K, Muller G, Ellert U: Blood pressure and lipid management fall far short in persons with type 2 diabetes: results from the DIAB-CORE Consortium including six German population-based studies. Cardiovasc Diabetol. 2012, 11: 50-10.1186/1475-2840-11-50. PubMedCentralCrossRefPubMed
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR: Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012, 35 (6): 1364-1379. 10.2337/dc12-0413. PubMedCentralCrossRefPubMed
Ott P, Köhler C, Hanefeld M: Baseline data of the Diabetes in Germany study (DIG). Prospective 4-year study on the epidemiology of type-2 diabetes in Germany. Diabetologe. 2006, 2 (Suppl. 1): S44-S48. CrossRef
Hanefeld M, Koehler C, Gallo S, Benke I, Ott P: Impact of the individual components of the metabolic syndrome and their different combinations on the prevalence of atherosclerotic vascular disease in type 2 diabetes: the Diabetes in Germany (DIG) study. Cardiovasc Diabetol. 2007, 6: 13-10.1186/1475-2840-6-13. PubMedCentralCrossRefPubMed
Koehler C, Ott P, Benke I, Hanefeld M, Group DIGS: Comparison of the prevalence of the metabolic syndrome by WHO, AHA/NHLBI, and IDF definitions in a German population with type 2 diabetes: the Diabetes in Germany (DIG) Study. Horm Metab Res. 2007, 39 (9): 632-635. 10.1055/s-2007-985816. CrossRefPubMed
Gitt AK, Bramlage P, Binz C, Krekler M, Deeg E, Tschope D: [Comorbidity, hypoglycaemia and appropriate selection of antidiabetic pharmacotherapy in diabetic patients with heart failure in clinical practice in Germany. Results of the DiaRegis registry]. Herz. 2012, 37 (3): 294-300. 10.1007/s00059-012-3611-3. CrossRefPubMed
American Diabetes A: Standards of medical care in diabetes--2012. Diabetes Care. 2012, 35 (Suppl 1): S11-S63.
Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clement D, Coca A, Dominiczak A, et al: Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens. 2009, 27 (11): 2121-2158. 10.1097/HJH.0b013e328333146d. CrossRefPubMed
Murad MH, Shah ND, Van Houten HK, Ziegenfuss JY, Deming JR, Beebe TJ, Smith SA, Guyatt GH, Montori VM: Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences. J Clin Epidemiol. 2011, 64 (7): 743-748. 10.1016/j.jclinepi.2010.08.005. CrossRefPubMed
- Achievement of recommended glucose and blood pressure targets in patients with type 2 diabetes and hypertension in clinical practice – study rationale and protocol of DIALOGUE
Anselm K Gitt
Roland E Schmieder
DIALOGUE Study Group*
- BioMed Central
Neu im Fachgebiet Innere Medizin
Meistgelesene Bücher aus der Inneren Medizin
Mail Icon II