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Slow-acting insulin analogues vs. NPH insulin There are three SRs (151-153) and a report from a Canadian agency with an SR and a meta-analysis (154) which have assessed the effectiveness and safety of the different types of insulin. Three of them assess insulins glargine and detemir in comparison to NPH insulin, while the third type (152), funded by the manufacturer, aims to assess only the hypoglycaemia events of insulin glargine. The studies included in the reviews compare single night insulin glargine doses in contrast to one or two doses of NPH insulin, while the comparison of insulin detemir in contrast to NPH insulin is with one or two doses of both. The duration of the studies is limited in time (24-52 weeks), which makes it difficult to detect differences in variables such as micro- and macroangiopathy. The variables assessed are glycemic control measured as glycosylated haemoglobin values and the hypoglycaemias as safety variables. The latter are assessed as total night and severe hypoglycaemias without any standardization of their definition and their recording. In some studies, these are referred by the patients themselves, without masking of the treatment received. There are no differences in glycemic control between insulin glargine or detemir in contrast to NPH insulin. There are no differences either between the number of severe hypoglycaemias, though there is in the total number of hypoglycaemias, especially at the expense of night hypoglycaemias, which are less than with analogues. The number of severe hypoglycaemias is seldom found in the RCTs included in the SRs. Appendix 3 describes the guidelines to begin the insulinization process and the use of hypoglycaemic drugs. Appendix 4 records the hypoglycaemia treatment. SR of RCT 1+ Evidence summary 1+ The combination of single night dose NPH insulin associated with an oral anti-diabetic drug provides glycemic control comparable to monotherapy with insulin every 12 hours or on a multiple schedule (144). 1+ In comparison with the insulin monotherapy, the combination of metformin with insulin improves glycemic control (reduction of HbA 1 c) with less weight gain (145-147). The results on the frequency of hypoglycaemias are contradictory (144-1<strong>46</strong>; 148), though a higher incidence has been proved as the treatment intensifies. There are no data on morbimortality. 1+ The studies which compare the different insulins are not designed to show differences in micro- and macrovascular complications and they do not provide data on quality of life or patients’ preferences (151-154). 1+ There are no significant differences as regards glycemic control assessed by means of glycosylated haemoglobin between the slow-acting insulin analogues and NPH insulin. Slow acting insulin analogues are associated with a lower risk of hypoglycaemias at the expense of the reduction of night hypoglycaemias (151-154). 72 CLINICAL PRACTICE GUIDELINES IN THE NHS
1+ There are no significant differences as regards glycemic control assessed by means of glycosylated haemoglobin between fast-acting insulin analogues and fast-acting human insulin. There are no differences in the frequency of hypoglycaemias (149; 150). Recommendations A A D CPG When treatment with insulin is started, it is recommendable to keep up the therapy with metformin and/or sulfonylureas. The need to continue with sulfonylureas or to reduce their dosage due to the risk of hypoglycaemias is to be reviewed. In DM 2 patients who require insulinization, the general use of insulin analogues is recommended. The use of slow-acting insulin analogues in patients with increased risk of night hypoglycaemias is recommended. DM 2 patients who require intensive insulinization, are not recommended the use of fast-acting analogues, as they present no advantages. DCPG When selecting an initial insulin schedule, the patient’s preference, the adverse effects risks (mainly hypoglycaemia) and the costs are to be taken into consideration. Figure 2. DM 2 treatment algorithm INTERVENTION ON LIFE STYLE (diet and exercise) 3-6 months Monotherapy HbA 1 c ≥ 7% f METFORMIN a A sulfonylurea can be considered for patients not overweight (BMI < 25) HbA 1 c ≥ 7% f Double therapy METFORMIN b + SULFONYLUREA c Insulin rejection SU + MET + PIOGLITAZONE. HbA 1 c ≥ 7% f, g Combined treatment: oral anti-diabetic drug + INSULIN NIGHT INSULIN (NPH) d + METFORMIN ± SULFONYLUREAS e HbA 1 c ≥ 7% f, g (METFORMIN ± SULFONYLUREAS) + Intensify the treatment with insulin in two or more dose a If intolerance to Metformin, use Sulfonylureas. b If intolerance to Metformin, Pioglitazone. c If Sulfonylureas are contraindicated or the patient follows irregular meals, use metiglinides (Repaglinide, Nateglinide). d If the patient suffers night-time hypoglycaemias, use slow-acting insulin analogue (Glargine or Detemir). e Review the need to continue with sulfonylureas or reduce the dose due to risk of hypoglycaemias. f The HbA 1 c ³7% target is for guidance. The aim is to be set individually, depending on cardiovascular risk, comorbidity, disease evolution time, life expectancy and the patients’ preferences. g Before insulinization start and during the intensifi cation process, less strict aims can be considered. CLINICAL PRACTICE GUIDELINE ON TYPE 2 DIABETES 73
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Clinical Practice Guideline on type
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A bibliographic record of this work
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Table of Contents Presentation 9 Au
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11. Diabetic foot. Assessment, prev
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Presentation Care practice is becom
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Other collaborations Rosa Rico Itur
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13. Which drug combination strategi
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Summary of recommendations Defi nit
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D CPG B B B B A daily single dose
Page 23 and 24: A B CPG Hypertense patients with DM
Page 25 and 26: Treatment for diabetic foot ulcers
Page 27: 1. Introduction Effective care for
Page 31 and 32: 3. Methodology Methodology. Evidenc
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Page 35: However, the quality of the assista
Page 38 and 39: 5.2. Risk factors for the developme
Page 40 and 41: 5.2.8. Diet and alcohol Type of die
Page 42 and 43: 5.2.12. Heart failure The associati
Page 44 and 45: The ADA does not recommend it for c
Page 46 and 47: Figure 1. DM 2 diagnostic algorithm
Page 48 and 49: 46 CLINICAL PRACTICE GUIDELINES IN
Page 50 and 51: 6.1. Impaired Fating Glucoseucose (
Page 52 and 53: 1++ An intensive intervention on li
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Page 56 and 57: 7.1.4. Other dietary interventions
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Page 60 and 61: duration and intensity). Performing
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Page 66 and 67: without heart failure. In this stud
Page 68 and 69: B B B B Metillinides can play a ro
Page 70 and 71: Recommendations B A A B B B B When
Page 72 and 73: 8.2. Insulin therapy 8.2.1. Associa
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Page 79 and 80: The validity and applicability of a
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Page 87: Recommendations B/D A B CPG Patient
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Page 94 and 95: Summary of evidence 1++ In hyperten
Page 96 and 97: An SR on drugs to treat diabetic ne
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Page 107 and 108: B D CPG B Diabetic foot screening m
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Page 111: 2+ The culture has a limited value
Page 114 and 115: • Promote healthy lifestyles: die
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Page 118 and 119: 12.3. Contents and methods of an ed
Page 120 and 121: Assessment of self-management recor
Page 122 and 123: 13.4. Referral criteria to medical
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Appendices Appendix 1. Levels of Ev
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Appendix 2. DM 2 diet Estimating ca
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CLINICAL PRACTICE GUIDELINE ON TYPE
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GPL-1 Analogues Biguanides Glitazon
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Devices FLEXPEN (Novo Nordisk): OPT
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Treatment for an unconscious patien
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Appendix 6. Assessment of macro- an
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Appendix 8. Use of monofilament Mon
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Indicators of final outcomes • Nu
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Impaired Glucose Tolerance (IGT): I
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IGT INSIGHT Trial IV LDL LH LIFE Tr
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Bibliography 1. Estrategia en diabe
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33. Iso H, Date C, Wakai K, Fukui M
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64. Screening for type 2 diabetes.
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97. Thomas DE, Elliott EJ, Naughton
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129. Lincoff AM, Wolski K, Nicholls
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157. Natarajan S, Liao Y, Cao G, Li
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185. de GG. Low-dose aspirin and vi
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214. Rahman M, Pressel S, Davis BR,
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245. NZGG. Management of type 2 dia
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279. Norris SL, Nichols PJ, Caspers
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