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Centre for Clinical Practice at NICE (UK). Type 2 Diabetes: Newer Agents for Blood Glucose Control in Type 2 Diabetes. London: National Institute for Health and Clinical Excellence (UK); 2009 May. (NICE Clinical Guidelines, No. 87.)

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Type 2 Diabetes: Newer Agents for Blood Glucose Control in Type 2 Diabetes.

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3References, glossary and abbreviations

3.1 References

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  2. Bagust A, Beale S. Modelling EuroQol health-related utility values for diabetic complications from CODE-2 data. Health Economics. 2005;14:217–30. [PubMed: 15386666]
  3. Barnett AH, Burger J, Johns D, et al. Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial. Clinical Therapeutics. 2007;29:2333–48. [PubMed: 18158075]
  4. Berhanu P, Perez A, Yu S. Effect of pioglitazone in combination with insulin therapy on glycaemic control, insulin dose requirement and lipid profile in patients with type 2 diabetes previously poorly controlled with combination therapy. Diabetes Obes Metab. 2007;9(4):512–20. [PubMed: 17587394]
  5. Bolli G, Dotta F, Rochotte E, et al. Efficacy and tolerability of vildagliptin vs. pioglitazone when added to metformin: a 24-week, randomized, double-blind study. Diabetes Obes Metab. 2008;10:82–90. [PubMed: 18034842]
  6. Celeya JM, Fon F, Ayala C, et al. A pharmacoeconomic evaluation for diabetes type 2 (DM 2) with inhibitors of dipeptidyl peptidase-4 (DPP-4) and thiazolidinediones (TZD) in monotherapy. Value in Health. 2007;10:A254.
  7. Davis SN, Johns D, Maggs D, et al. Exploring the substitution of exenatide for insulin in patients with type 2 diabetes treated with insulin in combination with oral antidiabetes agents. Diabetes Care. 2007;30:2767–72. [PubMed: 17595353]
  8. DeFronzo RA, Ratner RE, Han J, et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005;28:1092–100. [PubMed: 15855572]
  9. Diamond GA, Bax L, Kaul S. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Annals of Internal Medicine. 2007;147:578–81. [PubMed: 17679700]
  10. Dormandy JA, Charbonnel B, Eckland DJ, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366:1279–89. [PubMed: 16214598]
  11. Fernandez M, Triplitt C, Wajcberg E, et al. Addition of pioglitazone and ramipril to intensive insulin therapy in type 2 diabetic patients improves vascular dysfunction by different mechanisms. Diabetes Care. 2008;31:121–7. [PubMed: 17909084]
  12. Fon F, Celeya JM, Ayala C, et al. A pharmacoeconomic evaluation for diabetes type 2 (DM 2) with inhibitors of dipeptidyl peptidase-4 (DPP-4) and thiazolidinediones (TZD) as add-on therapy. Value in Health. 2007;10:A254.
  13. Heine RJ, Van Gaal LF, Johns D, et al. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Annals of Internal Medicine. 2005;143:559–69. [PubMed: 16230722]
  14. Hermansen K, Kipnes M, Luo E, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007;9:733–45. [PubMed: 17593236]
  15. Horvath K, Jeitler K, Berghold A, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2007;(2):CD005613. [PubMed: 17443605]
  16. Jagger C, Goyder E, Clarke M, et al. Active life expectancy in people with and without diabetes. Journal of Public Health Medicine. 2003;25:42–6. [PubMed: 12669917]
  17. Kendall DM, Riddle MC, Rosenstock J, et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005;28:1083–91. [PubMed: 15855571]
  18. Lago RM, Singh PP, Nesto RW. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials. Lancet. 2007;370:1129–36. [PubMed: 17905165]
  19. Lincoff AM, Wolski K, Nicholls SJ, et al. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA. 2007;298:1180–8. [PubMed: 17848652]
  20. Mattoo V, Eckland D, Widel M, et al. Metabolic effects of pioglitazone in combination with insulin in patients with type 2 diabetes mellitus whose disease is not adequately controlled with insulin therapy: results of a six-month, randomized, double-blind, prospective, multicenter, parallel-group study. Clinical Therapeutics. 2005;27:554–67. [PubMed: 15978304]
  21. McEwan P, Poole CD, Tetlow T, et al. Evaluation of the cost-effectiveness of insulin glargine versus NPH insulin for the treatment of type 2 diabetes in the UK. Current Medical Research and Opinion. 2007;23:S21–S31.
  22. Montanana CF, Herrero CH, Fernandez MR. Less weight gain and hypoglycaemia with once-daily insulin detemir than with NPH insulin in basal-bolus therapy of overweight type 2 diabetes patients: the PREDICTIVE-BMT trial. Diabetologia. 2007;50:S404. [PubMed: 18959604]
  23. National Institute for Health and Clinical Excellence. Type 2 diabetes: the management of type 2 diabetes, NICE clinical guideline. 2008. Available from www​.nice.org.uk/CG66.
  24. Nauck MA, Duran S, Kim D, et al. A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia. 2007;50:259–67. [PubMed: 17160407]
  25. Nauck MA, Meininger G, Sheng D, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007;9:194–205. [PubMed: 17300595]
  26. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. New England Journal of Medicine. 2007;356:2457–71. [PubMed: 17517853]
  27. Pan CY, Sinnassamy P, Chung KD, et al. Insulin glargine versus NPH insulin therapy in Asian Type 2 diabetes patients. Diabetes Research & Clinical Practice. 2007;76:111–8. [PubMed: 17011662]
  28. Philis-Tsimikas A, Charpentier G, Clauson P, et al. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clinical Therapeutics. 2006;28:1569–81. [PubMed: 17157113]
  29. Psaty BM, Furberg CD. The record on rosiglitazone and the risk of myocardial infarction. New England Journal of Medicine. 2007;357:67–9. [PubMed: 17551162]
  30. Ray JA, Boye KS, Yurgin N, et al. Exenatide versus insulin glargine in patients with type 2 diabetes in the UK: a model of long-term clinical and cost outcomes. Current Medical Research and Opinion. 2007;23:609–22. [PubMed: 17355742]
  31. Raz I, Stranks S, Filipczak R, et al. Efficacy and safety of biphasic insulin aspart 30 combined with pioglitazone in type 2 diabetes poorly controlled on glibenclamide (glyburide) monotherapy or combination therapy: an 18-week, randomized, open-label study. Clinical Therapeutics. 2005;27:1432–43. [PubMed: 16291416]
  32. Richter B, Bandeira-Echtler E, Bergerhoff K, et al. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2008;(2):CD006739. [PubMed: 18425967]
  33. Rosenstock J, Davies M, Home PD, et al. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008;51:408–16. [PMC free article: PMC2235909] [PubMed: 18204830]
  34. Rosenstock J, Einhorn D, Hershon K, et al. Efficacy and safety of pioglitazone in type 2 diabetes: a randomised, placebo-controlled study in patients receiving stable insulin therapy. International Journal of Clinical Practice. 2002;56:251–7. [PubMed: 12074206]
  35. Scheen A, Charbonnel B. Reduced insulin requirements and improved glycemic control with pioglitazone in insulin-treated patients with type 2 diabetes. Diabetes. 2006;55:A134.
  36. Schwarz B, Gouveia M, Chen J, et al. Cost-effectiveness of sitagliptin-based treatment regimens in European patients with type 2 diabetes and haemoglobin A1c above target on metformin monotherapy. Diabetes, Obesity and Metabolism 10 Suppl. 2008;1:43–55. [PubMed: 18435673]
  37. Scott R, Loeys T, Davies MJ, et al. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008;10:959–69. [PubMed: 18201203]
  38. Secnik BK, Matza LS, Oglesby A, et al. Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes. Health & Quality of Life Outcomes. 2006;4:80. [PMC free article: PMC1634743] [PubMed: 17034640]
  39. Shah PK, Mudahar S, Aroda V, et al. Weight gain and fat distribution with pioglitazone in patients with type 2 diabetes on insulin therapy. Journal of Investigative Medicine. 2007;55(Supplement):S95.
  40. Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA. 2007;298:1189–95. [PubMed: 17848653]
  41. Smith I, Palmer AJ, Roze S, et al. Cost-effectiveness analysis of insulin detemir compared to NPH insulin in patients with type 2 diabetes in the United Kingdom. Value in Health. 2004;7:735–6.
  42. Tran K, Banerjee S, Li H, et al. Short-acting insulin analogues for diabetes mellitus: meta-analysis of clinical outcomes and assessment of cost-effectiveness. Ottawa: The Canadian Agency for Drugs and Technologies in Health (CADTH); 2007.
  43. Valentine WJ, Erny-Albrecht KM, Ray JA, et al. Therapy conversion to insulin detemir among patients with type 2 diabetes treated with oral agents: a modeling study of cost-effectiveness in the United States. Advances in Therapy. 2007;24:273–90. [PubMed: 17565917]
  44. Warren E, Weatherley-Jones E, Chilcott J, et al. Systematic review and economic evaluation of a long-acting insulin analogue, insulin glargine. Health Technology Assessment. 2004;8:iii, 1–iii,57. [PubMed: 15525480]
  45. Woehl A, Evans M, Tetlow AP, et al. Evaluation of the cost effectiveness of exenatide versus insulin glargine in patients with suboptimally controlled Type 2 diabetes in the United Kingdom. Cardiovascular Diabetology. 2008;7:24. [PMC free article: PMC2546382] [PubMed: 18694484]
  46. Yurgin N, Secnik K, Hayes C, et al. Patient reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes. Diabetologia. 2006;49:474–5. [PMC free article: PMC1634743] [PubMed: 17034640]
  47. Zinman B, Hoogwerf BJ, Duran GS, et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Annals of Internal Medicine. 2007;146:477–85. [PubMed: 17404349]

3.2 Glossary and abbreviations

3.2.1 Glossary

Cohort study

(also known as follow-up, incidence, longitudinal, or prospective study): an observational study in which a defined group of people (the cohort) is followed over time. Outcomes are compared in subsets of the cohort who were exposed or not exposed (or exposed at different levels) to an intervention or other factor of interest.

Comorbidity

Two or more diseases or conditions occurring at the same time, such as depression and anxiety.

Confidence interval

The range within which the ‘true’ values (for example, size of effect of an intervention) are expected to lie with a given degree of certainty (for example, 95% or 99%). (Note: confidence intervals represent the probability of random errors, but not systematic errors or bias.)

Cost-effectiveness analysis (CEA)

An economic evaluation that compares alternative options for a specific patient group looking at a single effectiveness dimension measured in a non-monetary (natural) unit. It expresses the result in the form of an incremental (or average or marginal) cost-effectiveness ratio (ICER).

Economic evaluation

Technique developed to assess both costs and consequences of alternative health strategies and to provide a decision-making framework.

Guideline Development Group (GDG)

A group of healthcare professionals, patients, carers and members of the Short Clinical Guidelines Technical Team who develop the recommendations for a clinical guideline. The group writes draft guidance, and then revises it after a consultation with organisations registered as stakeholders.

Generalisability

The degree to which the results of a study or systematic review can be extrapolated to other circumstances, particularly routine healthcare situations in the NHS in England and Wales.

Heterogeneity

A term used to illustrate the variability or differences between studies in the estimates of effects.

Odds ratio

A measure of treatment effectiveness. The odds of an event happening in the intervention group, divided by the odds of it happening in the control group. The ‘odds’ is the ratio of non-events to events.

Quality-adjusted life year

A statistical measure, representing 1 year of life with full quality of life.

Randomised controlled trial

A form of clinical trial to assess the effectiveness of medicines or procedures. Considered reliable because it tends not to be biased.

Relative risk

Also known as risk ratio; the ratio of risk in the intervention group to the risk in the control group. The risk (proportion, probability or rate) is the ratio of people with an event in a group to the total in the group. An RR of 1 indicates no difference between comparison groups. For undesirable outcomes, an RR that is less than 1 indicates that the intervention was effective in reducing the risk of that outcome.

Systematic review

Research that summarises the evidence on a clearly formulated question according to a pre-defined protocol using systematic and explicit methods to identify, select and appraise relevant studies, and to extract, collate and report their findings. It may or may not use statistical meta-analysis.

3.2.2 Abbreviations

BMI

body mass index

CI

confidence interval

DPP-4

dipeptidyl peptidase-4

GLP-1

glucagon-like peptide-1

HbA1c

glycated haemoglobin

HDL

high-density lipoprotein

ICER

incremental cost-effectiveness ratio

OR

odds ratio

QALY

quality-adjusted life year

RR

relative risk

SPC

summary of product characteristics

UKPDS

UK Prospective Diabetes Study

Copyright © 2009, National Institute for Health and Clinical Excellence.

All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of NICE.

Bookshelf ID: NBK61849
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