review of the newer anti-diabetic therapies in the...

Adapted with permission from surveys and audits developed by NHS Haringey Clinical Commissioning Group, NHS Lambeth Clinical Commissioning Group and NHS Southwark Clinical Commissioning Group. Developed April 2015

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Review of the Newer Anti-diabetic Therapies in the Management of Type 2 Diabetes Mellitus in Adults

Aim To assess whether the prescribing of newer agents for Type 2 diabetes is in accordance with National Institute for Health and Clinical Excellence (NICE) guidance. Objectives

To assess if newer agents for Type 2 diabetes are being initiated in line with NICE guidance

To assess if the effectiveness of the newer agents for Type 2 diabetes are being reviewed in line with NICE guidance

To determine whether patients on the newer agents are being reviewed for their benefits annually Background Type 2 Diabetes is a progressive long term condition. Management involves optimising glycaemic control and appropriately managing cardiovascular risk through a combination of non-pharmacological and pharmacological interventions to prevent/delay macrovascular and microvascular complications. Optimising both non-pharmacological and pharmacological interventions ensures good early glycaemic control and improves outcomes for patients. Acting early to prevent complications limits the impact on people’s lives and saves the NHS money.

Numerous studies have shown that there can be considerable delays in treatment intensification in people with Type 2 diabetes where the average sub-optimal control is between 5 – 7 years prior to insulin initiation.

In May 2008 NICE produced “Type 2 Diabetes –newer agent’s clinical guideline 87” (CG87), which partially updated and replaced NICE clinical guideline 66. CG87 outlines pathways for the management of Type 2 diabetes including recommendations for optimising glycaemic control, blood pressure management and lipid control. Since this date a number of technology appraisals and new medicine evidence summaries have been published for the newer anti-diabetic agents that have entered the market since the publication of the guidelines. These include:

Liraglutide for the treatment of type 2 diabetes mellitus (Technology Appraisal 203)

Exenatide prolonged release suspension for injection in combination with oral anti-diabetic therapy for the treatment of type 2 diabetes (Technology Appraisal 248)

Type 2 diabetes –Lixisenatide (Evidence Summaries- New Medicines 10)

Dapagliflozin in combination therapy for treating type 2 diabetes (Technology Appraisal 288)

Canagliflozin in combination therapy for treating type 2 diabetes (Technology Appraisal 315)

Empagliflozin in combination therapy for treating type 2 diabetes (Technology Appraisal 336) In these documents, NICE make recommendations regarding place in therapy, monitoring, and in places, where agents should be used in preference to others. NICE have also published quality standards for Diabetes in adults (NICE Quality Standard 6). The key statements relating to medication are: Statement 4 - People with diabetes agree with their healthcare professional a documented personalised HbA1c target, usually between 48 mmol/mol and 58 mmol/mol (6.5% and 7.5%), and receive an ongoing review of treatment to minimise hypoglycaemia.

Statement 5 - People with diabetes agree with their healthcare professional to start, review and stop medications to lower blood glucose, blood pressure and blood lipids in accordance with NICE guidance.

This review will assess adherence to NICE guidance recommendations for initiation, monitoring and review criteria for the following newer agents:


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Oral dipeptidyl peptidase 4 (DPP-4) inhibitors - alogliptin, linagliptin, saxagliptin, sitagliptin and vildagliptin

Oral thiazolidinediones - pioglitazone

Glucagon-like peptide-1 (GLP-1) analogues – exenatide, liraglutide, lixisenatide and dulaglitide

Sodium glucose transporter-2 (SGLT-2) inhibitors – dapagliflozin, canagliflozin and empagliflozin

NICE make additional recommendations stating that HbA1c levels should be monitored 2-6 monthly (tailored to individual needs) until the blood glucose level is stable on unchanging therapy and 6 monthly once the blood glucose level and therapy are stable. This review will also look at adherence to a minimum of annual reviews of therapy.


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Standards

Number Criteria Standard Exceptions

1 DPP-4 inhibitors are initiated in line with NICE guidance 90% With documented evidence

2 There is evidence in the patients notes that potential benefits and risks of treatment with a DPP-4 inhibitor have been discussed prior to initiation*

100% nil

3 DPP-4 inhibitors are continued after six months of therapy only if a reduction of at least 0.5 percentage points in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved

100% With documented evidence

4 DPP-4 inhibitor therapy are reviewed at least annually for an assessment of efficacy and appropriateness


5 Pioglitazone therapy is initiated in line with NICE guidance 90% With documented evidence

6 There is evidence in the patients notes that potential benefits and risks of treatment with pioglitazone have been discussed prior to initiation (including bladder cancer)*

100% nil

7 Pioglitazone is not initiated in people who have heart failure, or who are at higher risk of fracture.

100% nil

8 Pioglitazone is continued after six months of therapy only if a reduction of at least 0.5 percentage points in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved


9 Pioglitazone therapy is reviewed at least annually for an assessment of efficacy, safety and appropriateness


7 GLP-1 analogues are initiated in line with NICE guidance 90% With documented evidence

8 There is evidence in the patients notes that potential benefits and risks of treatment with a GLP-1 analogue have been discussed prior to initiation*

100% nil

9 GLP-1 analogues are continued after six months of therapy only if:

1. At least a 1 percentage point reduction in HbA1c (DCCT values) or 12mmol/mol (IFCC values) is seen from baseline values AND**

2. At least a 3% body weight reduction is seen from baseline values


10 GLP-1 analogues therapy are reviewed at least annually for an assessment of efficacy and appropriateness


11 SGLT-2 inhibitors are initiated in line with NICE guidance 90% With documented evidence

12 There is evidence in the patients notes that potential benefits and risks of treatment with a SGLT-2 inhibitor have been discussed prior to initiation*

100% nil

13 SGLT-2 inhibitors are continued after six months of therapy only if a reduction of at least 0.5 percentage points in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved


14 SGLT-2 inhibitors are reviewed at least annually for an assessment of efficacy and appropriateness


*Please see summary of product characteristics (www.medicines.org.uk) and information from the Medicines and Healthcare Products Regulatory Agency for further information. **For third line use both criteria need to be met. For second line use, only HbA1c reductions need to be met

http://www.medicines.org.uk/


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Undertaking the review

Step 1:

1. Run a computer search for all patients with a prescription for the “Newer Agents” listed below including their brand names (listed in brackets) in the last 12 months:

Alogliptin (Vipidia®▼), alogliptin and metformin combination tablets (Vipdomet®▼), linagliptin (Trajenta®▼), linagliptin and metformin combination tablets (Jentadueto®▼), saxagliptin (Onglyza®), saxagliptin and metformin combination tablets (Komboglyze®), sitagliptin (Januvia®), sitagliptin and metformin combination products (Janumet®) and vildagliptin (Galvus®), and vildagliptin and metformin combination tablets (Eucreas®)

Pioglitazone (Actos®) and pioglitazone and metformin combination tablets (Competact®)

Dulaglutide (Trulicity®▼), exenatide (Byetta®, Bydureon®), liraglutide (Victoza®), liraglutide and insulin degludec combination products (Xultophy®▼) and lixisenatide (Lyxumia®▼)

Canagliflozin (Invokana®▼) and canagliflozin and metformin combination tablets (Vokanamet®▼), dapagliflozin (Forxiga®▼) and dapagliflozin and metformin combination tablets (Xigduo®▼) and empagliflozin (Jardiance®▼)

Step 2: Undertake the review and complete sections of the data collection form relevant to the patients identified:

Table 1 for patients taking DPP-4 inhibitors (see appendix 1 for a summary of NICE guidance related to DPP-4 inhibitors)

Table 2 for patients taking pioglitazone (see appendix 2 for a summary of NICE guidance related to pioglitazone)

Table 3 for patients taking GLP-1 analogues (see appendix 3 for a summary of NICE guidance related to GLP-1 analogues)

Table 4 for patients taking SGLT-2 inhibitors (see appendix 4 for a summary of NICE guidance related to SGLT-2 inhibitors)

Step 3: Complete the review summary sheet on page 9. Share findings at a practice meeting and develop an action plan to improve any areas where standards were not met. Patients who have not met NICE criteria should be called for a review of therapy with the practice/referred to the local diabetes team as appropriate.


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Data Collection Sheets Table 1: DPP-4 inhibitors

D1 D2 D3 D4 D5 D6 D7

Patient ID Therapy initiated in line with NICE

guidance? (Y/N)

Discussion regarding potential benefits and

risks of treatment documented in notes

(Y/N)

HbA1c at start of therapy

HbA1c after 6 months of therapy

Therapy continued after six months only if a reduction of at least 0.5 percentage points

in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is

achieved (Y/N)

Patients therapy reviewed in the last

year (Y/N)

Comments


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Table 2: Pioglitazone

P1 P2 P3 P4 P5 P6 P7 P8 Patient ID Therapy initiated in

line with NICE guidance? (Y/N)

Discussion regarding potential benefits

and risks of treatment

documented in notes including bladder cancer

(Y/N)

Pioglitazone has not been initiated in those with heart failure, or those

with a high risk of fracture

(Y/N)



Therapy continued after six months

only if a reduction of at least 0.5

percentage points in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved

(Y/N)


year (Y/N)

Comments


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Table 3: GLP-1 analogues

G1 G2 G3 G4 G5 G6 G7 G8 Patient ID Therapy initiated in

line with NICE guidance? (Y/N)

Discussion regarding potential benefits

and risks of treatment

documented in notes (Y/N)

HbA1c and weight at start of therapy

HbA1c and weight after 6 months of

therapy

Second line use$ -

therapy continued after six months

only if a reduction of at least one

percentage point in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved

(Y/N)

Third line use - therapy continued

after six months only if a reduction of

at least one percentage point in

HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved AND a reduction of 3% of bodyweight

from baseline

(Y/N)


year (Y/N)

Comments

$NICE recommend the use of liraglutide and exenatide prolonged release as either second or third line therapies. Exenatide standard release is recommended as third line therapy only.


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Table 4: SGLT-2 inhibitors

S1 S2 S3 S4 S5 S6 S7

Patient ID Therapy initiated in line with NICE

guidance? (Y/N)

Discussion regarding potential benefits and

risks of treatment documented in notes

(Y/N)



Therapy continued after six months only if a reduction of at least 0.5 percentage points

in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is

achieved (Y/N)


year (Y/N)

Comments


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Review summary sheets

Completed by ………………………………………………………………………………. Date……………………………………………Practice Name………………………………………………………………. Number Criteria Standard Where to find the

information % achieved Action plan/learning

1 DPP-4 inhibitors are initiated in line with NICE guidance 90% Table 1, column D1

2 There is evidence in the patients notes that potential benefits and risks of treatment with a DPP-4 inhibitor have been discussed prior to initiation

100% Table 1, column D2

3 DPP-4 inhibitors are continued after six months of therapy only if a reduction of at least 0.5 percentage points in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved


4 DPP-4 inhibitor therapy are reviewed at least annually for an assessment of efficacy and appropriateness


5 Pioglitazone therapy is initiated in line with NICE guidance 90% Table 2, column P1

6 There is evidence in the patients notes that potential benefits and risks of treatment with pioglitazone have been discussed prior to initiation (including bladder cancer)

100% Table 2, column P2

7 Pioglitazone is not initiated in people who have heart failure, or who are at higher risk of fracture. 100% Table 2, column P3

8 Pioglitazone is continued after six months of therapy only if a reduction of at least 0.5 percentage points in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved


9 Pioglitazone therapy is reviewed at least annually for an assessment of efficacy, safety and appropriateness


7 GLP-1 analogues are initiated in line with NICE guidance 90% Table 3, column G1

8 There is evidence in the patients notes that potential benefits and risks of treatment with a GLP-1 analogue have been discussed prior to initiation

100% Table 3, column G2

9 GLP-1 analogues are continued after six months of therapy only if: 1. At least a 1 percentage points in HbA1c (DCCT values) or 12mmol/mol (IFCC values)

reduction is seen from baseline values AND**

2. At least a 3% body weight reduction is seen from baseline values

100% Table 3, column G5 & G6

10 GLP-1 analogue therapy are reviewed at least annually for an assessment of efficacy and appropriateness

100% Table 3, column G7

11 SGLT-2 inhibitors are initiated in line with NICE guidance 90% Table 4, column S1

12 There is evidence in the patients notes that potential benefits and risks of treatment with a SGLT-2 inhibitor have been discussed prior to initiation

100% Table 4, column S2

13 SGLT-2 inhibitors are continued after six months of therapy only if a reduction of at least 0.5 percentage points in HbA1c (DCCT values) or 6mmol/mol (IFCC values) is achieved

100% Table 4, column S5

14 SGLT-2 inhibitors are reviewed at least annually for an assessment of efficacy and appropriateness 100% Table 4, column S6 **For third line use both criteria need to be met. For second line use, only HbA1c reductions need to be met


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Appendix 1 - Summary of NICE guidance for DPP-4 inhibitors for Type 2 diabetes NICE guidance 87 refers to sitagliptin and vildagliptin only as at the time of publication these were the only DPP-4 inhibitors available in the UK. Alogliptin, linagliptin and saxagliptin are now available. NICE criteria and guidance should be followed in line with all licensed indications.

DPP-4 inhibitors – second line therapy

Consider DPP-4 inhibitor (sitagliptin, vildagliptin) instead of a sulfonylurea as second-line therapy to first-line metformin when control of blood glucose remains or becomes inadequate (HbA1c ≥ 6.5%, or other higher level agreed with the individual) if:

the person is at significant risk of hypoglycaemia or its consequences (for example, older people and people in certain jobs [for example, those working at heights or with heavy machinery] or people in certain social circumstances [for example, those living alone]), or

the person does not tolerate a sulfonylurea or a sulfonylurea is contraindicated. Consider DPP-4 inhibitor (sitagliptin, vildagliptin) as second line therapy to sulfonylurea monotherapy when control of blood glucose remains or becomes inadequate (HbA1c ≥ 6.5%, or other higher level agreed with the individual) if:

the person does not tolerate metformin, or metformin is contraindicated.

DPP-4 inhibitors – third line therapy

Consider adding sitagliptin as third-line therapy to first-line metformin and a second-line sulfonylurea when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5% or other higher level agreed with the individual) and insulin is unacceptable or inappropriate.

DPP-4 inhibitors – Continuation criteria

Only continue DPP-4 inhibitor therapy (sitagliptin, vildagliptin) if the person has had a beneficial metabolic response (a reduction of at least 0.5 percentage points in HbA1c in 6 months).

DPP-4 inhibitors - general prescribing points

Discuss the potential benefits and risks of treatment with a DPP-4 inhibitor with the person to enable them to make an informed decision.

A DPP-4 inhibitor (sitagliptin, vildagliptin) may be preferable to pioglitazone if: further weight gain would cause or exacerbate significant problems associated with a high body weight, or pioglitazone is contraindicated, or the person has previously had a poor response to, or did not tolerate, pioglitazone

There may be some people for whom either a DPP-4 inhibitor (sitagliptin, vildagliptin) or pioglitazone may be suitable and, in this case, the choice of treatment should be based on patient preference


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Appendix 2: Summary of NICE guidance for pioglitazone for Type 2 diabetes

Pioglitazone - second line therapy

Consider adding pioglitazone instead of a sulfonylurea as second-line therapy to first-line metformin when control of blood glucose remains or becomes inadequate (HbA1c ≥ 6.5%, or other higher level agreed with the individual) if:

the person is at significant risk of hypoglycaemia or its consequences (for example, older people and people in certain jobs [for example, those working at heights or with heavy machinery] or people in certain social circumstances [for example, those living alone]), or

person does not tolerate a sulfonylurea or a sulfonylurea is contraindicated. Consider adding pioglitazone as second-line therapy to first-line sulfonylurea monotherapy when control of blood glucose remains or becomes inadequate (HbA1c ≥ 6.5%, or other higher level agreed with the individual) if:

the person does not tolerate metformin or metformin is contraindicated.

Pioglitazone - third line therapy

Consider adding pioglitazone as third-line therapy to first line metformin and a second-line sulfonylurea when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual) and insulin is unacceptable or inappropriate

Pioglitazone - continuation criteria

Only continue pioglitazone if the person has had a beneficial metabolic response (a reduction of at least 0.5 percentage points in HbA1c in 6 months)

Pioglitazone - general prescribing points

Do not commence or continue pioglitazone in people who have heart failure, or who are at higher risk of fracture. When selecting pioglitazone take into account up-to-date advice from the relevant regulatory bodies (the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency), cost, safety and prescribing issues.

Consider combining pioglitazone with insulin therapy for a person: o who has previously had a marked glucose-lowering response to thiazolidinedione therapy (pioglitazone), or o who is on high-dose insulin therapy and whose blood glucose is inadequately controlled.

Discuss the potential benefits and risks of treatment with pioglitazone with the person to enable them to make an informed decision.

Pioglitazone may be preferable to a DPP-4 inhibitor (sitagliptin, vildagliptin) if: o the person has marked insulin insensitivity, or o a DPP-4 inhibitor (sitagliptin, vildagliptin) is contraindicated, or o the person has previously had a poor response to, or did not tolerate, a DPP-4 inhibitor (sitagliptin, vildagliptin).

There may be some people for whom either a pioglitazone or a DPP-4 inhibitor (sitagliptin, vildagliptin) may be suitable and, in this case, the choice of treatment should be based on patient preference.


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Appendix 3: Summary of NICE guidance for GLP-1 analogues for Type 2 diabetes

Exenatide twice daily (standard release)

NICE (CG 87) recommends considering adding a GLP-1 analogue (exenatide) as third-line therapy to first-line metformin and a second-line sulfonylurea when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual), and the person has:

o BMI≥35.0 kg/m2 in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high

body weight OR o BMI<35.0 kg/m

2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities

Treatment should be continued only if a reduction of at least 1 percentage point in HbA1c AND weight loss of at least 3% of initial body weight have been achieved at 6 months.

Discuss the potential benefits and risks of treatment

Exenatide weekly (prolonged release)

NICE (TA 248) Prolonged-release exenatide in triple therapy regimens (in combination with metformin and a sulfonylurea, or metformin and a thiazolidinedione) is recommended for the treatment of type 2 diabetes, only when glycaemic control is inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual), and the patient has:

o BMI≥35 kg/m² in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight OR

o BMI<35 kg/m², and insulin would have significant occupational implications or weight loss would benefit other significant obesity related co-morbidities.

Treatment should be continued only if a reduction of at least 1 percentage point HbA1c AND weight loss of at least 3% of initial body weight are achieved at 6 months

Prolonged-release exenatide in dual therapy regimens (in combination with metformin or a sulphonylurea) is recommended only if: o treatment with metformin or a sulphonylurea is contra-indicated or not tolerated, and o treatment with thiazolidinediones and dipeptidyl peptidase-4 inhibitors is contra-indicated or not tolerated

Treatment should be continued only if HbA1c is reduced by at least 1 percentage point at 6 months of therapy.

Liraglutide

NICE (TA 203) 1.2g daily as triple therapy regimens (in combination with metformin & a sulfonylurea OR metformin and a thiazolidinedione) if control of blood sugar becomes inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual) AND the person has:

o BMI≥35 kg/m² in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight OR

o BMI<35 kg/m², and insulin would have significant occupational implications or weight loss would benefit other significant obesity related co-morbidities.

Treatment should be continued only if a reduction of at least 1 percentage point in HbA1c AND weight loss of at least 3% of initial body weight are achieved at 6 months

Liraglutide in dual therapy regimens (in combination with metformin or a sulfonylurea) is recommended only if: o treatment with metformin or a sulfonylurea is contra-indicated or not tolerated, AND o treatment with thiazolidinediones and dipeptidyl peptidase-4 inhibitors is contra-indicated or not tolerated.

Treatment should be continued only if HbA1c is reduced by at least 1 percentage point at 6 months

NICE do not recommend the use of Liraglutide 1.8mg daily


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Lixisenatide

Local Formulary and Guideline Recommendations

To date, NICE have not formally reviewed the use of lixisenatide in Type 2 diabetes. Please review prescribing of lixisenatide in line with your local formulary and guideline recommendations and the summary of product characteristics found at www.medicines.org.uk

Dulaglutide


To date, NICE have not formally reviewed the use of dulaglutide in Type 2 diabetes. Please review prescribing of dulaglutide in line with your local formulary and guideline recommendations and the summary of product characteristics found at www.medicines.org.uk

Combination use of GLP-1 analogues and insulin


To date, NICE have not formally reviewed the combination use of GLP-1 analogues and insulin in Type 2 diabetes. Please review prescribing of this combination in line with your local formulary and guideline recommendations and the summary of product characteristics found at www.medicines.org.uk





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Appendix 4 - Summary of NICE guidance for SGLT-2 inhibitors for Type 2 diabetes

Canagliflozin - dual therapy

Canagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if a sulfonylurea is contraindicated or not tolerated or the person is at significant risk of hypoglycaemia or its consequences.

Canagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

Canagliflozin - triple therapy

Canagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in combination with metformin and a sulfonylurea or metformin and a thiazolidinedione.

Canagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

Dapagliflozin - dual therapy

Dapagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if it is used as described for dipeptidyl peptidase-4 (DPP-4) inhibitors in Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87).

Dapagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

Dapagliflozin - triple therapy

Dapagliflozin in a triple therapy regimen in combination with metformin and a sulfonylurea is not recommended for treating type 2 diabetes, except as part of a clinical trial.

Empagliflozin - dual therapy

Empagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if a sulfonylurea is contraindicated or not tolerated, or the person is at significant risk of hypoglycaemia or its consequences.

Empagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

Empagliflozin - triple therapy

Empagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in combination with metformin and a sulfonylurea or metformin and a thiazolidinedione.

Empagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.

SGLT-2 inhibitor continuation criteria (based on NICE TA288 for dapagliflozin)

Only continue SGLT-2 inhibitor therapy if the person has had a beneficial metabolic response (a reduction of at least 0.5 percentage points in HbA1c at 6 months)


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http://www.lambethccg.nhs.uk/news-and-publications/meeting-papers/south-east-london-area-prescribing-committee/Documents/Shared%20Care%20Protocols/SGLT2%20inhibitors%20in%20Type%202%20Diabetes%20GP%20information%20sheet%20April%202015.pdf
