Quality statement 4: First intensification of blood glucose lowering therapy in type 2 diabetes

Quality statement

Adults with type 2 diabetes whose HbA1c level is 58 mmol/mol (7.5%) or above after 6 months with single-drug treatment are offered dual therapy. [new 2016]

Rationale

Good blood glucose control in people with type 2 diabetes is important for mitigating the risk of microvascular and macrovascular complicationsassociated with hyperglycaemia, such as damage to the eyes, kidneys and nerves. If HbA1c levels are not well controlled with single-drug treatment, it is important to offer intensification of drug treatment, as well as reinforcing advice about diet, lifestyle and adherence to drug treatment and supporting the person to aim for an HbA1c level of 53 mmol/mol (7.0%). A timescale of 6 months allows time to improve diet, lifestyle and adherence to drug treatment, while also ensuring that first intensification is not unnecessarily delayed. Timely first intensification can delay the need for second intensification, which may involve insulin therapy.

Quality measures

Structure

Evidence of local arrangements to ensure that adults with type 2 diabetes are offered dual therapy if their HbA1c level is 58 mmol/mol (7.5%) or above after 6 months with single-drug treatment.

Data source: Local data collection.

Process

Proportion of adults with type 2 diabetes who are started on dual therapy when their HbA1c level is 58 mmol/mol (7.5%) or above after 6 months with single-drug treatment.

Numerator – the number in the denominator who are started on dual therapy.

Denominator – the number of adults with type 2 diabetes whose HbA1c level is 58 mmol/mol (7.5%) or above after 6 months with single-drug treatment.

Data source: Local data collection.

Outcome

a) Adults with type 2 diabetes feel supported to aim for an HbA1c level of 53 mmol/mol (7.0%) or less.

Data source: Local data collection.

b) Incidence of diabetes-related complications.

Data source: Local data collection. National data are collected in the National Diabetes Audit.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as GPs and community healthcare providers) ensure that processes are in place so that adults with type 2 diabetes whose HbA1c level is 58 mmol/mol (7.5%) or above after 6 months with single-drug treatment are offered dual therapy.

Healthcare professionals (such as GPs, practice nurses and community healthcare providers) ensure that they offer dual therapy to adults with type 2 diabetes whose HbA1c level is 58 mmol/mol (7.5%) or above after 6 months with single-drug treatment. They also reinforce advice about diet, lifestyle and adherence to treatment.

Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which adults with type 2 diabetes whose HbA1c level is 58 mmol/mol (7.5%) or above after 6 months with single-drug treatment are offered dual therapy.

What the quality statement means for patients, service users and carers

Adults with type 2 diabetes who need medication to control their blood glucose levels usually start off by taking a single medicine. If after 6 months this first medicine doesn't help or their diabetes gets worse over time, despite advice about diet, lifestyle and taking the medicine properly, they are offered another type of medicine as well as the one they already take.

Source guidance

Definitions of terms used in this quality statement

Dual therapy

Consider dual therapy with:

  • metformin and a DPP-4 inhibitor or

  • metformin and pioglitazone[2] or

  • metformin and a sulfonylurea.

If metformin is contraindicated or not tolerated, consider dual therapy[3] with

  • a DPP-4 inhibitor and pioglitazone[2] or

  • a DPP-4 inhibitor and a sulfonylurea or

  • pioglitazone[2] and a sulfonylurea.

Treatment with combinations of medicines including sodium–glucose cotransporter 2 (SGLT‑2) inhibitors may be appropriate for some people with type 2 diabetes; see the NICE guidance on canagliflozin in combination therapy for treating type 2 diabetes, dapagliflozin in combination therapy for treating type 2 diabetes and empagliflozin in combination therapy for treating type 2 diabetes.

[Adapted from NICE's guideline on Type 2 diabetes in adults: management, recommendations 1.6.25 and 1.6.26]

Equality and diversity considerations

An individualised approach to diabetes care should be taken that is tailored to the needs and circumstances of each adult with type 2 diabetes. The target HbA1c level may need to be relaxed on a case-by-case basis. Examples include adults who have a reduced life expectancy, adults for whom tight blood glucose control poses a high risk of the consequences of hypoglycaemia and adults with significant comorbidities for whom intensive management would not be appropriate. Particular consideration should be given for people who are older or frail.



[2] When prescribing pioglitazone, exercise particular caution if the person is at high risk of the adverse effects of the drug. Pioglitazone is associated with an increased risk of heart failure, bladder cancer and bone fracture. Known risk factors for these conditions, including increased age, should be carefully evaluated before treatment: see the manufacturers' summaries of product characteristics for details. Medicines and Healthcare products Regulatory Agency (MHRA) guidance (2011) advises that 'prescribers should review the safety and efficacy of pioglitazone in individuals after 3–6 months of treatment to ensure that only patients who are deriving benefit continue to be treated'.

[3] Be aware that the drugs in dual therapy should be introduced in a stepwise manner, checking for tolerability and effectiveness of each drug.