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1. /2.03.12 УКПМД цукровий д_абет.doc
2. /АКН ЦД 2 тип.doc
Уніфікований клінічний протокол медичної допомоги цукровий діабет тип 2
Діабет 2 типу
Diabetes, Obesity

& Metabolism 2006;8(4):436–447.

163 Poon T, Nelson P, Shen L et al. Exenatide improves glycemic control and reduces body weight in subjects

with type 2 diabetes: a dose-ranging study. Diabetes Technology & Therapeutics 2005;7(3):467–477.

164 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(8):559–569.

165 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).

166 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 noninferiority

study. Diabetologia 2007;50(2):259–267.

167 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(7):

477–485.

168 European Medicines Agency. EPARs for authorised medicinal products for human use. Available from:

www.emea.europa.eu. Last accessed on: 19 January 2008.

169 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 & Opinion 2007;23(3):

609–622.

170 Goudswaard AN, Furlong NJ, Rutten GE et al. Insulin monotherapy versus combinations of insulin with

oral hypoglycaemic agents in patients with type 2 diabetes mellitus. Cochrane Database of Systematic

Reviews 2004;(4):CD003418.

171 Kokic SB. Lispro insulin and metformin versus other combination in the diabetes mellitus type 2

management after secondary oral antidiabetic drug failure. Collegium Antropologicum 2003;27(1):181–187.

172 Olsson PO, Lindstrom T. Combination-therapy with bedtime nph insulin and sulphonylureas gives

similar glycaemic control but lower weight gain than insulin twice daily in patients with type 2 diabetes.

Diabetes & Metabolism 2002;28(4:Pt 1):272–277.

173 Altuntas Y, Ozen B, Ozturk B et al. Comparison of additional metformin or NPH insulin to mealtime

insulin lispro therapy with mealtime human insulin therapy in secondary OAD failure. Diabetes, Obesity

& Metabolism 2003;5(6):371–378.

174 Kabadi MU, Kabadi UM. Efficacy of sulfonylureas with insulin in type 2 diabetes mellitus. Annals of

Pharmacotherapy 2003;37(11):1572–1576.

175 Zargar AH, Masoodi SR, Laway BA et al. Response of regimens of insulin therapy in type 2 diabetes mellitus

subjects with secondary failure. Journal of the Association of Physicians of India 2002;50(5):641–646.

176 Douek IF, Allen SE, Ewings P et al. Continuing metformin when starting insulin in patients with type 2

diabetes: a double-blind randomized placebo-controlled trial. Diabetic Medicine 2005;22(5):634–640.

177 Goudswaard AN, Stolk RP, Zuithoff P et al. Starting insulin in type 2 diabetes: continue oral hypoglycemic

agents? A randomized trial in primary care. Journal of Family Practice 2004;53(5):393–399.

178 Janka HU, Plewe G, Riddle MC et al. Comparison of basal insulin added to oral agents versus twice-daily

premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 2005; 28(2):254–259.

179 Stehouwer MH, DeVries JH, Lumeij JA et al. Combined bedtime insulin – daytime sulphonylurea regimen

compared with two different daily insulin regimens in type 2 diabetes: effects on HbA1c and hypoglycaemia

rate – a randomised trial. Diabetes/Metabolism Research and Reviews 2003;19(2):148–152.


Посилання

180 Lechleitner M, Roden M, Haehling E et al. Insulin glargine in combination with oral antidiabetic drugs as

a cost-equivalent alternative to conventional insulin therapy in type 2 diabetes mellitus. Wiener Klinische

Wochenschrift 2005;117(17):593–598.

181 Drummond M, O’Brien B, Stoddart G, Torrance G. Methods for economic evaluation of health care

programmes, 2nd edn. Oxford: Oxford University Press, 2003.

182 Christiansen JS, Vaz JA, Metelko Z. Twice daily biphasic insulin aspart improves postprandial glycaemic

control more effectively than twice daily NPH insulin, with low risk of hypoglycaemia, in patients with

type 2 diabetes. Diabetes, Obesity & Metabolism 2003;5(6):446–454.

183 Kilo C, Mezitis N, Jain R et al. Starting patients with type 2 diabetes on insulin therapy using once-daily

injections of biphasic insulin aspart 70/30, biphasic human insulin 70/30, or NPH insulin in combination

with metformin. Journal of Diabetes & its Complications 2003;17(6):307–313.

184 Ceriello A, Del PS, Bue VJ et al. Premeal insulin lispro plus bedtime NPH or twice-daily NPH in patients

with type 2 diabetes: acute postprandial and chronic effects on glycemic control and cardiovascular risk

factors. Journal of Diabetes & its Complications 2007;21(1):20–27.

185 Siebenhofer A, Plank J, Berghold A et al. Short acting insulin analogues versus regular human insulin in

patients with diabetes mellitus. Cochrane Database of Systematic Reviews 2006;(2):CD003287.

186 Boehm BO, Home PD, Behrend C et al. Premixed insulin aspart 30 vs. premixed human insulin 30/70

twice daily: a randomized trial in type 1 and type 2 diabetic patients [erratum appears in Diabetic Medicine.

2002 Sep;19(9):797]. Diabetic Medicine 2002;19(5):393–399.

187 Boehm BO, Vaz JA, Brondsted L et al. Long-term efficacy and safety of biphasic insulin aspart in patients

with type 2 diabetes. European Journal of Internal Medicine 2004;15(8):496–502.

188 Abrahamian H, Ludvik B, Schernthaner G et al. Improvement of glucose tolerance in type 2 diabetic

patients: traditional vs. modern insulin regimens (results from the Austrian Biaspart Study). Hormone &

Metabolic Research 2005;37(11):684–689.

189 Schernthaner G, Kopp HP, Ristic S et al. Metabolic control in patients with type 2 diabetes using Humalog

Mix50 injected three times daily: crossover comparison with human insulin 30/70. Hormone & Metabolic

Research 2004;36(3):188–193.

190 Ligthelm RJ, Mouritzen U, Lynggaard H et al. Biphasic insulin aspart given thrice daily is as efficacious as

a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four

months comparison in patients with type 2 diabetes. Experimental & Clinical Endocrinology & Diabetes

2006;114(9):511–519.

191 Joshi SR, Kalra S, Badgandi M et al. Designer insulins regimens in clinical practice – pilot multicenter

Indian study. Journal of the Association of Physicians of India 2005;53(Sept):775–779.

192 Davies M, Storms F, Shutler S. Initiation of Insulin Glargine in type 2 patients with suboptimal glycaemic

control on twice-daily premix insulin: results from the AT.LANTUS trial. Diabetologia 2004;47(Suppl 1):

319.

193 National Institute for Clinical Excellence. The clinical effectiveness and cost effectiveness of long acting insulin

analogues for diabetes (TA53). London: NICE, 2002.

194 Rosenstock J, Dailey G, Massi-Benedetti M et al. Reduced hypoglycemia risk with insulin glargine: a metaanalysis

comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care 2005;

28(4):950–955.

195 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 of Systematic Reviews 2007;(2):CD005613.

196 Yki JH, Kauppinen MR, Tiikkainen M et al. Insulin glargine or NPH combined with metformin in type 2

diabetes: the LANMET study. Diabetologia 2006;49(3):442–451.

197 Herman WH, Ilag LL, Johnson SL et al. A clinical trial of continuous subcutaneous insulin infusion versus

multiple daily injections in older adults with type 2 diabetes. Diabetes Care 2005;28(7):1568–1573.

198 Raskin P, Allen E, Hollander P et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic

and basal insulin analogs. Diabetes Care 2005;28(2):260–265.


Діабет 2 типу.

199 Eliaschewitz FG, Calvo C, Valbuena H et al. Therapy in type 2 diabetes: insulin glargine vs. NPH insulin

both in combination with glimepiride. Archives of Medical Research 2006;37(4):495–501.

200 Rosskamp R. Safety and efficacy of insulin glargine (HOE 901) versus NPH insulin in combination with

oral treatment in type 2 diabetic patients. Diabetic Medicine 2003;20(7):545–551.

201 Malone JK, Kerr LF, Campaigne BN et al. Combined therapy with insulin lispro mix 75/25 plus metformin

or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with

type 2 diabetes beginning insulin therapy. Clinical Therapeutics 2004;26(12):2034–2044.

202 Malone JK, Bai S, Campaigne BN et al. Twice-daily pre-mixed insulin rather than basal insulin therapy

alone results in better overall glycaemic control in patients with type 2 diabetes. Diabetic Medicine

2005;22(4): 374–381.

203 Jacober SJ, Scism BJ, Zagar AJ. A comparison of intensive mixture therapy with basal insulin therapy in

insulin-naive patients with type 2 diabetes receiving oral antidiabetes agents. Diabetes, Obesity &

Metabolism 2006;8(4):448–455.

204 Kann PH, Wascher T, Zackova V et al. Starting insulin therapy in type 2 diabetes: twice-daily biphasic

insulin aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Experimental &

Clinical Endocrinology & Diabetes 2006;114(9):527–532.

205 Kazda C, Hulstrunk H, Helsberg K et al. Prandial insulin substitution with insulin lispro or insulin lispro

mid mixture vs. basal therapy with insulin glargine: a randomized controlled trial in patients with type 2

diabetes beginning insulin therapy. Journal of Diabetes & its Complications 2006;20(3):145–152.

206 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(1):111–118.

207 Raskin PR, Hollander PA, Lewin A et al. Basal insulin or premix analogue therapy in type 2 diabetes

patients. European Journal of Internal Medicine 2007;18(1):56–62.

208 Yokoyama H, Tada J, Kamikawa F et al. Efficacy of conversion from bedtime NPH insulin to morning

insulin glargine in type 2 diabetic patients on basal-prandial insulin therapy. Diabetes Research & Clinical

Practice 2006;73(1):35–40.

209 Standl E, Maxeiner S, Raptis S et al. Once-daily insulin glargine administration in the morning compared

to bedtime in combination with morning glimepiride in patients with type 2 diabetes: an assessment of

treatment flexibility. Hormone & Metabolic Research 2006;38(3):172–177.

210 Gerstein HC, Yale JF, Harris SB et al. A randomized trial of adding insulin glargine vs. avoidance of insulin

in people with type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of

metformin and/or sulphonylureas. The Canadian INSIGHT (Implementing New Strategies with Insulin

Glargine for Hyperglycaemia Treatment) Study. Diabetic Medicine 2006;23(7):736–742.

211 Fritsche A, Schweitzer MA, Haring HU et al. Glimepiride combined with morning insulin glargine,

bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes.

A randomized, controlled trial. Annals of Internal Medicine 2003;138(12):952–959.

212 Massi BM, Humburg E, Dressler A et al. A one-year, randomised, multicentre trial comparing insulin

glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Hormone &

Metabolic Research 2003;35(3):189–196.

213 Riddle MC, Rosenstock J, Gerich J et al. The treat-to-target trial: randomized addition of glargine or

human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003;26(11):3080–3086.

214 Rosenstock J, Schwartz SL, Clark CM Jr et al. Basal insulin therapy in type 2 diabetes: 28-week comparison

of insulin glargine (HOE 901) and NPH insulin. Diabetes Care 2001;24(4):631–636.

215 Warren E, Weatherley-Jones E, Chilcott J et al. Systematic review and economic evaluation of a longacting

insulin analogue, insulin glargine. Health Technology Assessment 2004;8(45):iii, 1–57.

216 McEwan P, Poole CD, Telow T et al. Evaluation of the cost-effectiveness of insulin glargine versus NPH

insulin for the treatment of type 1 diabetes in the UK. Current Medical Research & Opinion 2007;23(1):

S7–S19.

217 National Institute for Health and Clinical Excellence. The clinical effectiveness and cost effectiveness of

insulin pump therapy (TA57). London: NICE, 2003.


Посилання

218 Little RR, Rohilfing CL, Wiedmeyer HM et al. The National Glycohaemoglobin Standardization Program

(NGSP): a five-year progress report. Clinical Chemistry 2001;47:1985–1992.

219 Coscelli C. Safety, efficacy, acceptability of a pre-filled insulin pen in diabetic patients over 60 years old.

Diabetes Research & Clinical Practice 1995;28(3):173–177.

220 Fox C, McKinnon C, Wall A et al. Ability to handle, and patient preference for, insulin delivery devices in

visually impaired patients with type 2 diabetes. Practical Diabetes International 2002;19(4):104–107.

221 Kadiri A, Chraibi A, Marouan F et al. Comparison of NovoPen 3 and syringes/vials in the acceptance of

insulin therapy in NIDDM patients with secondary failure to oral hypoglycaemic agents. Diabetes Research

& Clinical Practice 1998;41(1):15–23.

222 Korytkowski M, Bell D, Jacobsen C et al. A multicenter, randomized, open-label, comparative, two-period

crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional

vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. Clinical Therapeutics

2003;25(11):2836–2848.

223 Shelmet J. Preference and resource utilization in elderly patients: InnoLet versus vial/syringe. Diabetes

Research & Clinical Practice 2004;63(1):27–35.

224 Stockl K, Ory C, Vanderplas A et al. An evaluation of patient preference for an alternative insulin delivery

system compared to standard vial and syringe. Current Medical Research & Opinion 2007;23(1):133–146.

225 Asakura T, Seino H. Assessment of dose selection attributes with audible notification in insulin pen

devices. Diabetes Technology & Therapeutics 2005;7(4):620–626.

226 Turner R, Holman R, Stratton I et al. Tight blood pressure control and risk of macrovascular and

microvascular complications in type 2 diabetes (UKPDS 38). British Medical Journal 1998;317:703–713.

227 Sibal L, Law HN, Gebbie J et al. Cardiovascular risk factors predicting the development of distal

symmetrical polyneuropathy in people with type 1 diabetes: A 9-year follow-up study. Annals of the New

York Academy of Sciences 2006;1084:304–318.

228 Pohl MA, Blumenthal S, Cordonnier DJ et al. Independent and additive impact of blood pressure control

and angiotensin II receptor blockade on renal outcomes in the irbesartan diabetic nephropathy trial:

clinical implications and limitations. Journal of the American Society of Nephrology 2005;16(10):3027–3037.

229 Berl T, Hunsicker LG, Lewis JB et al. Impact of achieved blood pressure on cardiovascular outcomes in the

Irbesartan Diabetic Nephropathy Trial. Journal of the American Society of Nephrology 2005;16(7):2170–2179.

230 Matthews DR, Stratton IM, Aldington SJ et al. Risks of progression of retinopathy and vision loss related

to tight blood pressure control in type 2 diabetes mellitus (UKPDS 69). Archives of Opthalmology

2004;122(11):1631–1640.

231 Bakris GL, Weir MR, Shanifar S et al. Effects of blood pressure level on progression of diabetic

nephropathy: results from the RENAAL study. Archives of Internal Medicine 2003;163(13):1555–1565.

232 Estacio RO, Coll JR, Tran ZV et al. Effect of intensive blood pressure control with valsartan on urinary

albumin excretion in normotensive patients with type 2 diabetes. American Journal of Hypertension

2006;19(12):1241–1248.

233 Schrier RW, Estacio RO, Esler A et al. Effects of aggressive blood pressure control in normotensive type 2

diabetic patients on albuminuria, retinopathy and strokes. Kidney International 2002;61(3):1086–1097.

234 Turnbull F, Neal B, Algert C et al. Effects of different blood pressure-lowering regimens on major

cardiovascular events in individuals with and without diabetes mellitus: results of prospectively designed

overviews of randomized trials. Archives of Internal Medicine 2005;165(12):1410–1419.

235 Torffvit O, Agardh CD. A blood pressure cut-off level identified for renal failure, but not for macrovascular

complications in type 2 diabetes: a 10-year observation study. Hormone & Metabolic Research

2002;34(1):32–35.

236 Strippoli GF, Craig M, Craig JC. Antihypertensive agents for preventing diabetic kidney disease. Cochrane

Database of Systematic Reviews 2005;(4):CD004136.

237 Strippoli GF, Bonifati C, Craig M et al. Angiotensin converting enzyme inhibitors and angiotensin II

receptor antagonists for preventing the progression of diabetic kidney disease. Cochrane Database of

Systematic Reviews 2006;(4):CD006257.


Діабет 2 типу.

238 Casas JP, Chua W, Loukogeorgakis S et al. Effect of inhibitors of the renin-angiotensin system and other

antihypertensive drugs on renal outcomes: systematic review and meta-analysis. Lancet 2005;366(9502):

2026–2033.

239 Mann JF, Gerstein HC, Yi QL et al. Progression of renal insufficiency in type 2 diabetes with and without

microalbuminuria: results of the Heart Outcomes and Prevention Evaluation (HOPE) randomized study.

American Journal of Kidney Diseases 2003;42(5):936–942.

240 Mann JF, Gerstein HC, Yi QL et al. Development of renal disease in people at high cardiovascular risk:

results of the HOPE randomized study. Journal of the American Society of Nephrology 2003;14(3):641–647.

241 Bosch J. Long-term effects of ramipril on cardiovascular events and on diabetes: results of the HOPE study

extension. Circulation 2005;112(9):1339–1346.

242 Barnett AH, Bain SC, Bouter P et al. Angiotensin-receptor blockade versus converting-enzyme inhibition

in type 2 diabetes and nephropathy. New England Journal of Medicine 2004;351(19):1952–1961.

243 Sengul AM, Altuntas Y, Kurklu A et al. Beneficial effect of lisinopril plus telmisartan in patients with type

2 diabetes, microalbuminuria and hypertension. Diabetes Research & Clinical Practice 2006;71(2):210–219.

244 Dalla VM, Pozza G, Mosca A et al. Effect of lercanidipine compared with ramipril on albumin excretion rate

in hypertensive type 2 diabetic patients with microalbuminuria: DIAL study (diabete, ipertensione,

albuminuria, lercanidipina). Diabetes, Nutrition & Metabolism – Clinical & Experimental 2004;17(5):259–266.

245 Fogari R, Preti P, Zoppi A et al. Effects of amlodipine fosinopril combination on microalbuminuria in

hypertensive type 2 diabetic patients. American Journal of Hypertension 2002;15(12):1042–1049.

246 Ruggenenti P, Perna A, Ganeva M et al. Impact of blood pressure control and angiotensin-converting

enzyme inhibitor therapy on new-onset microalbuminuria in type 2 diabetes: a post hoc analysis of the

BENEDICT trial. Journal of the American Society of Nephrology 2006;17(12):3472–3481.

247 Whelton PK, Barzilay J, Cushman WC et al. Clinical outcomes in antihypertensive treatment of type 2

diabetes, impaired fasting glucose concentration, and normoglycemia: Antihypertensive and Lipid-Lowering

Treatment to Prevent Heart Attack Trial (ALLHAT).
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