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Type Diabetes

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									Type 2 diabetes: Notes for key slides 3 — Management of blood
glucose

Slide 1
In this third key slide set we are going to discuss the management of blood glucose,
focusing on oral hypoglycaemic agents and recommendations from the NICE Clinical
Guideline 66. Further background on the evidence for reducing blood glucose in
people with type 2 diabetes, including from the landmark UKPDS studies,2,3,4 is
summarised in Key slide set 1.


For further information and detail on this section please view Part 4 of the eLearning
in less than 60 minutes on-line presentation.

Slide 2
This is the guidance given by NICE in their type 2 diabetes guideline, around setting
targets for glucose control. They recommend an aspirational target glycated
haemoglobin or HbA1c level of 6.5% for people with type 2 diabetes in general.
However, they stress that it is important to set individualised HbA1c targets, which
may well be above this, involving the patient in the decision as to what is an
appropriate target for them. NICE also make it clear that highly intensive blood
glucose management to pursue ever lower HbA1c targets is not appropriate.1

Slide 3
So, what do NICE recommend for the management of blood glucose in type 2
diabetes? The next two slides show the NICE algorithm for blood glucose control.
As you can see metformin is the first-choice hypoglycaemic drug, with a
sulphonylurea an option if the patient is not overweight, if a rapid therapeutic
response is required, or if metformin is contraindicated or not tolerated.


If blood glucose control is inadequate on metformin alone, the addition of a
sulphonylurea is second-line therapy.


Rapid-acting insulin secretagogues, such as repaglinide and nateglinide, should only
be used for people with erratic lifestyles. These have not shown benefits over
sulphonylureas and are more expensive. Acarbose can be considered for people
This resource has been produced with the support of a number of NHS individuals and organisations. It is intended as a template from which you
                                        can produce local versions adapted to your own local needs.
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unable to use other oral hypoglycaemic agents. However, it has lower glucose-
lowering efficacy, a higher rate of intolerance and is more expensive than metformin
or sulphonylureas.1

Slide 4
The third-line option, if HbA1c levels remain above 7.5% is to initiate insulin therapy
or add in a thiazolidinedione (also called a glitazone).1


NICE recommend intermediate acting human isophane insulin (or human NPH
insulin as it is also called) as the preferred basal insulin, taken at bed-time or twice-
daily according to need.1


They recommend continuing metformin and sulphonylurea treatment when insulin is
initiated, reviewing the use of the sulphonylurea if hypoglycaemia occurs.1 Insulin
therapy is discussed in more detail in Part 4 of the eLearning in less than 60 minutes
on-line presentation, and also in the related workshop on type 1 diabetes, which can
be found on the Type 1 diabetes floor of NPCi.


If using insulin is likely to be unacceptable or ineffective, NICE suggest that
glitazones can be added to metformin and a sulphonylurea. Glitazones are also an
option in addition to a sulphonylurea if metformin is not tolerated or in addition to
metformin if a sulphonylurea is not appropriate. Exenatide is not recommended by
NICE for routine use in type 2 diabetes.1


It should be noted that this guidance on glitazones and exenatide will be updated in
the NICE Short Clinical Guideline on newer agents for type 2 diabetes, expected in
May 2009 – see our blogpage for details.1


Slide 5
Nationally the cost of oral hypoglycaemic prescribing is dominated by the glitazones
and, more recently, other drugs which include acarbose, meglitinides, gliptins and
exenatide (see Part 4 of <60 minute presentation). You may want to look at how
much your practice or Primary Care Trust (PCT) spends on these agents, and local
prescribing trends.

This resource has been produced with the support of a number of NHS individuals and organisations. It is intended as a template from which you
                                        can produce local versions adapted to your own local needs.
2

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In the Clinical Guideline 66, NICE recommend glitazones as third-line agents added
to metformin and a sulphonylurea if HbA1c is more than 7.5% (or other higher level
agreed with the individual), if human insulin is likely to be unacceptable or
ineffective.1


They can also be considered as second-line agents in people with HbA1c levels of at
least 6.5%, either added to metformin as an alternative to a sulphonylurea where
hypoglycaemia would be a particular issue, or added to a sulphonylurea where
metformin is not tolerated or contraindicated. Only pioglitazone▼, not rosiglitazone,
can be used with insulin.1


The new NICE guideline on newer agents for blood glucose in type 2 diabetes
should be consulted when this is published (due May 2009), as the glitazones
section will be updated.1


There are significant safety issues with glitazones that are discussed in more detail
in Part 4 of the 60 minute on-line presentation. Up to date prescribing advice from
the MHRA should be sought before initiating therapy.


Slide 6
So what is the evidence base for benefits from glitazones? This slide gives details of
the Cochrane Reviews for pioglitazone▼ and rosiglitazone, both of which concluded
that there is no convincing evidence that patient-oriented outcomes (POOs), such as
mortality, morbidity, adverse effects, costs or quality of life, are positively influenced
by either pioglitazone▼ or rosiglitazone.5,6


Slide 7
So what about safety concerns? Some of the side effects of glitazones have been
known since they were first licensed, and some are emerging as volume of use has
increased.
As detailed on this slide, in December 2007 the MHRA publication Drug Safety
Update stated that rosiglitazone might be associated with a small increased risk of
cardiac ischaemia, particularly in combination with insulin. Prescribing information
has been updated to include warnings that rosiglitazone should be used in patients
This resource has been produced with the support of a number of NHS individuals and organisations. It is intended as a template from which you
                                        can produce local versions adapted to your own local needs.
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with ischaemic heart disease only after careful evaluation of every patient’s individual
risk, and combined use with insulin should be used only in exceptional cases and
under close supervision.7


There is consistent evidence that both rosiglitazone and pioglitazone ▼ can cause
weight gain, fluid retention, and lead to new or worsening heart failure. This is not a
rare occurrence, and can be serious and sometimes fatal. A meta-analysis of three
randomised controlled trials (RCTs) estimated that about 1 in every 50 patients
taking a glitazone for 26 months would experience heart failure compared with those
taking placebo or another oral antidiabetic agent.8


The final safety issue with glitazones is an increased risk of fractures. This has been
seen in women, not men, given rosiglitazone and pioglitazone ▼. The MHRA have
stated that the risk of fracture should be considered in the care of patients, especially
women, treated with both glitazones.9 A meta-analysis of the fracture risk with both
glitazones has recently been published. It found glitazones approximately doubled
the relative risk of fractures in women, but not men.10


Slide 8
So are there any benefits in using the newer glucose-lowering treatments compared
with older treatments? This systematic review from 2007 found these newer, more
expensive oral hypoglycaemic agents offer no advantages over metformin and
sulphonylureas. POO data, such as effects on cardiovascular endpoints, are very
limited for the newer agents.11


A Drug and Therapeutics Bulletin provides useful information on the three newest
drugs for the management of blood glucose: exenatide and the oral gliptins,
sitagliptin and vildagliptin. There is no POO data for any of these new drugs.12
Recommendations on all these drugs, the glitazones, and the long-acting insulin
analogues are expected in the new guidance from NICE due to be published in May
2009.1


Slide 9

This resource has been produced with the support of a number of NHS individuals and organisations. It is intended as a template from which you
                                        can produce local versions adapted to your own local needs.
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The value of self-monitoring of blood glucose has been debated for many years. For
those people on insulin therapy who are adjusting their doses on the basis of their
blood glucose, there’s no debate about the value of self-monitoring. However, the
question is, what do people using lifestyle interventions or oral agents to control their
glycaemia actually do with the self-monitoring results?


NICE have now given very clear guidance on the place of self-monitoring in people
with type 2 diabetes, as shown on this slide. They recommend it should only be used
if it is going to be an integral part of the patients’ self-management education, and
the continued benefit of self-monitoring should be assessed in a structured way each
year. Self-monitoring of blood glucose is appropriate in some people with type 2
diabetes, and should be made available in these circumstances, which include
people on insulin therapy and during intercurrent illness or medication and lifestyle
changes.1


Two recently published RCTs have confirmed that, in patients with type 2 diabetes
not on insulin but who remain relatively well-controlled with oral drugs, little is to be
gained from promoting the self-monitoring of blood glucose, either in terms of
improved glycaemic control or better quality of life. Discussion of these studies and
links to original papers are available from an NPCi Blog.13

Attention and resources could then be directed to interventions likely to make a
difference to patients’ symptoms and CV risk; these include support and advice
around nutrition, exercise, smoking cessation, and foot care, etc.


As the guidelines have now clarified when self-monitoring is appropriate you may
want to look at how much your practice or PCT spends on blood glucose test strips,
and local prescribing trends, and debate whether this is a good use of the
prescribing budget.


References
1. NICE Full Clinical Guideline 66; Type 2 diabetes: the management of type 2
     diabetes. May 2008.

This resource has been produced with the support of a number of NHS individuals and organisations. It is intended as a template from which you
                                        can produce local versions adapted to your own local needs.
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2. UK Prospective Diabetes Study (UKPDS) Group. 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:
      837–853.
3. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-
      glucose control with metformin on complications in overweight patients with type
      2 diabetes (UKPDS 34). Lancet 1998;352:54–865.
4. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of
      macrovascular and microvascular complications in type 2 diabetes: UKPDS 38.
      BMJ 1998;317:703–713.
5. Richter B, et al. Pioglitazone for type 2 diabetes mellitus. Cochrane Database of
      Systematic Reviews 2006;(4):CD006060.
6. Richter B, et al. Rosiglitazone for type 2 diabetes mellitus. Cochrane Database of
      Systematic Reviews 2007;(3):CD006063.
7. Drug Safety Update 2007;1(5) Rosiglitazone and pioglitazone; cardiovascular
      safety.
8. MeReC Extra 30;November 2007. Update on the CV risk of glitazones.
9. Drug Safety Update 2007;1(3) Safety of glitazones; fracture risk
10. NPCi Blog 253. Glitazones double the risk of bone fracture in women.
11.   Bolen S, et al. Systematic Review: Comparative Effectiveness and Safety of Oral
      Medications for Type 2 Diabetes Mellitus. Ann Intern Med 2007;147:386-399.
12. Drug Ther Bull 2008;46(7):49–52 Three new drugs for type 2 diabetes.
13. NPCi Blog 102. Self-monitoring in type 2 diabetes not treated with insulin usually
      doesn't help, can worsen quality of life, and may waste NHS resources.




This resource has been produced with the support of a number of NHS individuals and organisations. It is intended as a template from which you
                                        can produce local versions adapted to your own local needs.
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