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Losing weight following type 2 diabetes diagnosis boosts chance of
`remission
`
`DIABETES, METABOLICS AND HORMONES | 21.11.19 | doi: 10.3310/signal-000841
`
`People who lose at least 10% of their body weight in the rst year after being diagnosed
`with type 2 diabetes increase their chances of being in remission after ve years, compared
`with those whose weight remains stable. Losing this achievable amount of weight over the
`next four years also makes remission more likely.
`
`In this study of 867 people, 257 (30%) achieved remission at ve-year follow-up. The
`participants had been taking part in a trial but had not received intensive lifestyle
`interventions or been put on extremely calorie-restricted diets.
`
`This NIHR-funded study strengthens the evidence that healthy behaviour change and
`weight loss can result in remission of type 2 diabetes. This nding may help to motivate
`people to lose weight soon after a diabetes diagnosis ─ setting realistic and achievable
`targets can make a difference in the longer term.
`
`Why was this study needed?
`
`Around 1 in 10 adults over 40 in the UK have been diagnosed with type 2 diabetes. This has
`been fuelled by the rise in obesity rates. Diabetes UK estimates that in addition to the 3.8
`million adults who have been diagnosed with type 2 diabetes, a further one million have the
`disease without knowing it. Diabetes and its complications, including kidney failure, loss of
`sight and lower limb amputations, cost the NHS £6 billion per year.
`
`Previous studies have shown that remission of type 2 diabetes, without medication or
`surgery, is achievable through intensive low-calorie diets and behaviour change in those
`who have lived with diabetes for some years. Many of these studies have also been
`relatively short.
`
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`
`Novo Nordisk Exhibit 2386
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`The present study looked at whether a more moderate approach could achieve remission
`over the longer term, and whether a window of opportunity exists following diagnosis when
`weight loss interventions may be both effective and acceptable.
`
`What did this study do?
`
`This was a prospective cohort study of 867 people, aged 40 to 69, newly diagnosed with
`diabetes. Participants had been enrolled in the ADDITION-Cambridge randomised
`controlled trial, from 49 East of England GP practices between 2002 and 2006. The trial
`randomised participants into an intervention group, who received additional support, or the
`control ‘usual care’ group. This cohort study pooled data from both groups to look at who
`achieved remission during ve years of follow-up.
`
`Participants’ weight, physical activity, diet and alcohol consumption at baseline and one
`year were assessed. At ve-year follow-up, 730 people (84%) had weight and HbA (long-
`1c
`term blood sugar measurement) measures taken. The participants were predominantly
`white.
`
`What did it nd?
`
`Diabetes remission, dened as an HbA level of less than 48mmol/mol (6.5%) in the
`1c
`absence of any diabetes medication or bariatric surgery, was achieved in 257
`participants (30%) at ve-year follow-up.
`
`People who lost at least 10% of their body weight in the rst year after diagnosis of
`diabetes were more likely to achieve remission at ve years compared to those with
`stable or increased weight (risk ratio [RR] 1.77, 95% condence interval [CI] 1.32 to
`2.38).
`
`Similar trends were observed in those who had more modest weight loss of 5 to 10%
`over the rst year after diagnosis, but this was not statistically signicant.
`
`In the subsequent four years (i.e. between the end of the rst year and the end of the
`ve-year study), achieving at least a 10% weight loss was associated with more than
`double the chance of remission at ve-year follow-up (RR 2.43, 95% CI 1.78 to 3.31).
`
`In this period weight loss of 5 to 10% was also associated with an increased likelihood
`Back to top 
`of remission (RR 1.43, 95% CI 1.03 to 1.98).
`
`Novo Nordisk Exhibit 2386
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`What does current guidance say on this issue?
`
`NICE’s guideline (NG28 updated in 2019), states that people diagnosed with type 2
`diabetes should receive personalised and ongoing dietary advice. This should be integrated
`within a personalised diabetes management plan that includes other lifestyle modications,
`such as losing weight and becoming more physically active.
`
`The guideline states that for overweight adults diagnosed with type 2 diabetes, an initial
`body weight loss target of 5 to 10% should be set. NICE notes that lesser degrees of weight
`loss may still be benecial and that a larger degree of weight loss in the longer term will
`have advantageous metabolic impact.
`
`What are the implications?
`
`This was a reasonably large cohort study whose ndings should be generalisable to wider
`UK diabetes populations. The ndings support the current guidelines around patient
`education and setting weight loss targets. Healthcare professionals and people newly
`diagnosed with type 2 diabetes will welcome the nding that relatively achievable weight
`loss in the rst year after diabetes diagnosis or within ve years can lead to disease
`remission.
`
`Further studies to conrm ndings in more diverse populations, such as black and ethnic
`minority groups who are at signicantly greater risk of developing type 2 diabetes, would
`be helpful.
`
`Citation and Funding
`
`Dambha‐Miller H, Day AJ, Strelitz J et al. Behaviour change, weight loss and remission of
`Type 2 diabetes: a community‐based prospective cohort study
`(https://onlinelibrary.wiley.com/doi/full/10.1111/dme.14122) . Diabet Med. 2019; Sept 3.
`doi: 10.1111/dme.14122. [Epub ahead of print].
`
`This project was funded by the NIHR Health Technology Assessment Programme (project
`number 08/116/300) as well as the Wellcome Trust (grant number: G061895), the
`Epidemiology Unit programme (MC_UU_12015/4), and the National Health Service R&D
`support funding.
`
`Back to top 
`

`
`Novo Nordisk Exhibit 2386
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`Bibliography
`
`MRC Epidemiology Unit. ADDITION. (http://www.mrc-
`epid.cam.ac.uk/research/studies/addition/) Cambridge: MRC Epidemiology Unit; accessed
`2019.
`
`NHS England. Type 2 diabetes and the importance of prevention.
`(https://www.england.nhs.uk/blog/type-2-diabetes-and-the-importance-of-prevention/)
`London: Department of Health and Social Care; updated April 2018.
`
`NICE. Type 2 diabetes in adults: management.
`(https://www.nice.org.uk/guidance/ng28/chapter/1-Recommendations#individualised-
`care) NG28. London: National Institute for Health and Care Excellence; updated August
`2019.
`
`Produced by the University of Southampton and Bazian on behalf of NIHR through the
`NIHR Dissemination Centre
`

`
`Back to top 
`
`Novo Nordisk Exhibit 2386
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

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