Draft guidance consultation
You can now review and comment on this draft guideline.
The consultation closes on Thursday 02 October 2025 at 5pm.
How to comment
1. Register your organisation or comment as an individual
If you’re commenting for an organisation, your organisation needs to be registered as a stakeholder.
Not eligible? Contact the Stakeholder that most closely represents your interests and pass your comments to them.
We can accept comments from individuals. These will be considered, but you won’t get a formal response and they won’t be posted on the NICE website. Wherever possible we encourage you to submit your comments through a registered stakeholder organisation.
2. Read the consultation documents
Documents to comment on:
- Draft guideline, which includes a refresh of the type 2 diabetes insulin-based treatment recommendations
- Evidence reviews: see section 5 evidence reviews for an explanation of all the evidence documents and links to each file. You can also access the files on the project documents page.
- Methods
- Economic model report
- Economic model
- Equality and health inequalities assessment (EHIA)
- Health inequalities report
- SGLT2 Uptake report
- Expert testimony – Trans Gap project
- Interests register
- Acknowledgements
We also invite comments on our Draft Resource impact template
If you want to review the economic model, please see 5. Economic models below and fill in the confidentiality form
Other information about the consultation:
- Committee membership list
Developing NICE guidelines: how to get involved
- Final scope – for information
3. Add your comments
- You must use this form.
- You must declare any links with, or funding from, the tobacco industry
If you share similar views with another organisation, send a joint response.
Make sure you consider:
- The areas that will have the biggest impact on practice and be challenging to implement
- How to help users overcome challenges
Developing NICE guidelines: how to get involved suggests some other areas to comment on.
4. Email the form to us
Email: [email protected]
Deadline: Thursday 02 October 2025 at 5pm
5. Economic model
The developer has produced an economic model to support the guideline on Type 2 diabetes in adults: management (medicines update). To receive an executable version of this model, please submit a request to [email protected] with a signed copy of the confidentiality acknowledgement and undertaking form.
We will then send you a link to an executable version of the economic model by email. The deadline for returning your comments is the same as for the guideline consultation: Thursday 02 October 2025 at 5pm.
6. Evidence review guide
The evidence reviews for the medicines updates are split into two questions:
- Report E: For different population subgroups, which individual and/or combinations of pharmacological therapies are most clinically and cost effective as initial treatment for the management of type 2 diabetes?
- Report F: For different population subgroups, which individual and/or combinations of pharmacological therapies are most clinically and cost effective as subsequent treatment for the management of type 2 diabetes?
The Committee discussion of the evidence for the two reviews is combined into one report.
The methods for both reviews can be found in the Methods document, while the methods for the network meta-analyses (NMA) can be found within each report discussing each specific analysis.
The Health economic modelling report relates to both reviews. The UPKDS model results are included with the report.
Two additional reports, one examining the uptake of SGLT2 inhibitors in people with type 2 diabetes and one that considers Health inequalities in accessing SGLT-2 inhibitors in the UK, which estimates the impact of different uptake scenarios of SGLT-2 inhibitors in people in UK primary care are included.
An Expert testimony was given by Dr Michael Ni’Man from the Trans Gap Project to discuss health inequalities for trans people with diabetes and scoring systems used.
Initial treatment (report E)
The characteristics of the review question are described in this table.
|
Population |
Adults (age ≥18 years) with type 2 diabetes mellitus stratified into five groups: people with heart failure; people with atherosclerotic cardiovascular disease; people with chronic kidney disease; people at low cardiovascular risk with no other comorbidities; people at high cardiovascular risk (or mixed/unclear cardiovascular risk) with no other comorbidities |
|
Intervention |
Pharmacological therapies for people with type 2 diabetes, including biguanides (metformin standard release and slow release); DPP-4 inhibitors (alogliptin, linagliptin, saxagliptin, sitagliptin and vildagliptin); GLP-1 receptor agonists (dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide); dual GIP/GLP-1 receptor co-agonists (tirzepatide); SGLT-2 inhibitors (canagliflozin, dapagliflozin, empagliflozin and ertugliflozin); sulfonylureas (gliclazide, glimepiride, glipizide and tolbutamide); thiazolidinediones (pioglitazone) and combinations of the therapies listed. |
|
Comparator |
Different therapies listed in the intervention section to each other; oral formulations compared to injectable formulations; insulin (all types and doses pooled together in the same class); placebo. |
|
Outcome |
Health-related quality of life; all-cause mortality; cardiovascular mortality; 3-item MACE; 4-item MACE; 5-item MACE; non-fatal stroke; non-fatal myocardial infarction; unstable angina; hospitalisation for heart failure; acute kidney injury; persistent signs of worsening kidney disease; development of end stage kidney disease; death from renal causes; cardiac arrhythmia; diabetic ketoacidosis; falls requiring hospitalisation; progression of liver disease; remission; hypoglycaemia episodes; at night hypoglycaemic episodes; severe hypoglycaemic episodes; HbA1c change; weight change; BMI change. All outcomes were assessed at the final time point reported in the trial. |
|
Study design |
Systematic reviews of randomised controlled trials |
This review is split into seven documents:
- E1.1, E1.2, E1.3: This contains the main study report and appendices A-D, which show the review protocol, literature search strategies, effectiveness evidence study selection and evidence summary tables.
- E2.1, E2.2, E2.3: This contains appendices E-K, which show the forest plots, GRADE tables, economic evidence study selection, economic evidence tables, excluded studies and risk of bias and directness tables.
- E3: This contains information about the network meta-analyses (NMAs) conducted for this review (for the population with type 2 diabetes at high risk of cardiovascular disease, for HbA1c change and weight change).
Subsequent treatment (report F)
The characteristics of the review question are described in this table.
|
Population |
Adults (age ≥18 years) with type 2 diabetes mellitus who are currently receiving therapy for type 2 diabetes, stratified into five groups: people with heart failure; people with atherosclerotic cardiovascular disease; people with chronic kidney disease; people at low cardiovascular risk with no other comorbidities; people at high cardiovascular risk (or mixed/unclear cardiovascular risk) with no other comorbidities |
|
Intervention |
Different pharmacological therapies being used after initial therapy has been taken by people with type 2 diabetes, including biguanides (metformin standard release and slow release); DPP-4 inhibitors (alogliptin, linagliptin, saxagliptin, sitagliptin and vildagliptin); GLP-1 receptor agonists (dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide); dual GIP/GLP-1 receptor co-agonists (tirzepatide); SGLT-2 inhibitors (canagliflozin, dapagliflozin, empagliflozin and ertugliflozin); sulfonylureas (gliclazide, glimepiride, glipizide and tolbutamide); thiazolidinediones (pioglitazone) and combinations of the therapies listed. Different strategies to optimise treatment: adding a new treatment; stopping a previous treatment; switching to a different treatment, |
|
Comparator |
Different strategies to optimise treatment; different therapies listed in the intervention section to each other; oral formulations compared to injectable formulations; insulin (all types and doses pooled together in the same class); placebo |
|
Outcome |
Health-related quality of life; all-cause mortality; cardiovascular mortality; 3-item MACE; 4-item MACE; 5-item MACE; non-fatal stroke; non-fatal myocardial infarction; unstable angina; hospitalisation for heart failure; acute kidney injury; persistent signs of worsening kidney disease; development of end stage kidney disease; death from renal causes; cardiac arrhythmia; diabetic ketoacidosis; falls requiring hospitalisation; progression of liver disease; remission; hypoglycaemia episodes; at night hypoglycaemic episodes; severe hypoglycaemic episodes; HbA1c change; weight change; BMI change. All outcomes were assessed at the final time point reported in the trial. |
|
Study design |
Systematic reviews of randomised controlled trials |
This review has been split into 24 documents:
- F2.1, F2.2, F2.3, F2.4, F2.5, F2.6, F2.7, F2.8, F2.9: This contains appendices A-D, which include the review protocol, literature search strategies, effectiveness evidence study selection and effectiveness evidence study summary tables.
- F3: This contains appendices E-F, which include the forest plots and GRADE tables for the population with type 2 diabetes and heart failure.
- F4: This contains appendices G-H, which include the forest plots and GRADE tables for the population with type 2 diabetes and cardiovascular disease.
- F5: This contains appendices I-J, which include the forest plots and GRADE tables for the population with type 2 diabetes and chronic kidney disease.
- F6: This contains appendix K, which includes the forest plots for the population with type 2 diabetes who were at high risk of developing cardiovascular disease.
- F7: This contains appendix L, which includes the GRADE tables for the population with type 2 diabetes who were at high risk of developing cardiovascular disease.
- F8.1, F8.2, F8.3: This contains appendices M-R, which includes the economic evidence study selection, economic evidence tables, excluded studies, research recommendation protocols and risk of bias and directness tables.
- F9: This contains the NMA report for NMAs conducted for people with type 2 diabetes and chronic kidney disease, heart failure and cardiovascular disease.
- F10: This contains the NMA report for NMAs on binary outcomes (cardiovascular mortality, 3-item MACE, 4-item MACE, 5-item MACE, non-fatal myocardial infarction, non-fatal stroke, unstable angina, hospitalisation for heart failure and development of end-stage renal failure) conducted for people with type 2 diabetes at high risk of developing cardiovascular disease. This also includes information about GRADE assessment for all NMAs conducted across both reviews and how absolute effect values were ascertained from hazard ratios.
- F11: This contains the NMA report for NMAs on continuous outcomes (HbA1c change and weight change) conducted for people with type 2 diabetes at high risk of developing cardiovascular disease.
- F12: This contains a report of the NMA for people with type 2 diabetes and chronic kidney disease for HbA1c change after an additional study was identified during rerun searches
- F13: This contains a report of the NMA for people with type 2 diabetes and chronic kidney disease for weight change after an additional study was identified during rerun searches
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