A1chieve

Contents

What is A1chieve®?

A1chieve® is the largest ever study on the use of insulin therapy in type 2 diabetes. It involves 66,726 people from 28 countries across Asia, Africa, Europe and Latin America.[1]

A1chieve® is an international, prospective, observational, multi-centre, open label, non-interventional 24-week study of insulin analogues in near-routine daily clinical practice run by Novo Nordisk. Before entering into the study, people were started on one of three Novo Nordisk insulin analogue regimens based on their physician’s clinical judgement: premix (biphasic insulin aspart 30 [NovoMix 30®]), basal (insulin detemir [Levemir®]), and meal-time (insulin aspart [NovoRapid®]).

The aims of A1chieve®

The primary aim of the study was to evaluate the clinical safety of the study insulins, assessed by the incidence of serious adverse drug reactions (SADRs) including rates of major hypoglycaemia (low blood sugar). In addition, effectiveness (blood glucose control [HbA1c] fasting plasma glucose, and postprandial plasma glucose) and patient quality of life outcomes were measured.[2]

Baseline data

Comprehensive epidemiological data were collected at baseline. These data show that before treatment with a Novo Nordisk insulin analogue was initiated, the average HbA1c among the study participants was 9.5 %, which is well above the internationally recognised target of 7 %.[3] Poor blood glucose control puts people at high risk of developing diabetes-related complications; in this study up to 80% of people had diabetes complications and 75% already had cardiovascular disease.[4]

Final results

After 24 weeks of treatment with a Novo Nordisk insulin analogue there was a significant reduction in HbA1c levels of 2.1 %, from 9.5 % to 7.4 %.[4] Reported rates of overall hypoglycaemia slightly increased in those new to insulin, from 1.07 to 1.19 events/person/year, and fell in those who switched from other insulin therapies from 7.31 to 2.48 events/person/year.[5] Furthermore patients’ reported quality of life improved significantly.[6] The total rate of reported SADRs after initiation of insulin analogues was 0.13 events/100 patient-years.

References

  1. ^ www.a1chieve.com
  2. ^ Shah, Siddharth N.; Litwak, León; Haddad, Jihad; Chakkarwar, Praful N.; Hajjaji, Issam (2010). "The A1chieve study: A 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice". Diabetes Research and Clinical Practice 88: S11–6. doi:10.1016/S0168-8227(10)70003-6. PMID 20466163
  3. ^ Soewondo P et al. Delay in beginning or optimizing insulin therapy despite poor glycemic control: data from the A1chieve® study. Abstract presented at ADA, San Diego, June 2011.
  4. ^ a b Zilov AV et al. Prevalence of complications of diabetes in people with type 2 diabetes: data from Asia, Europe and Latin America from the A1chieve® study. Abstract published at ADA, San Diego, June 2011
  5. ^ Home P, Naggar N E, Khamseh M et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res Clin Pract 2011; 94: 352-63. PII: S0168-8227(11)00562-6
  6. ^ Shah S, Zilov A, Malek R et al. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Research and Clinical Pract 2011; 94: 364-70. PII: S0168-8227(11)00563-8