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Table of Contents
EDITORIAL
Year : 2013  |  Volume : 17  |  Issue : 8  |  Page : 395-396

The A 1 chieve study: Mapping the Ibn Battuta trail


1 Department of Endocrinology, Bharti Hospital and BRIDE, Karnal, Haryana, India
2 Hedi Chaker Hospital, 3029 Sfax, Tunisia
3 Department of Endocrinology, S.L. Raheja Hospital, Mumbai, Maharashtra, India

Date of Web Publication27-Nov-2013

Correspondence Address:
Sanjay Kalra
Department of Endocrinology, Bharti Hospital and BRIDE, Karnal, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.122038

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How to cite this article:
Kalra S, Kamoun M, Shah SN. The A 1 chieve study: Mapping the Ibn Battuta trail. Indian J Endocr Metab 2013;17, Suppl S2:395-6

How to cite this URL:
Kalra S, Kamoun M, Shah SN. The A 1 chieve study: Mapping the Ibn Battuta trail. Indian J Endocr Metab [serial online] 2013 [cited 2019 Nov 22];17, Suppl S2:395-6. Available from: http://www.ijem.in/text.asp?2013/17/8/395/122038

Ibn Battuta (1304-69), the Moroccan explorer, was famous for his observational skills, as well as his multifaceted acumen. His travels extended from Morocco, his homeland, across North Africa, Arabia, and the Arabian Gulf, to India and beyond. His observations, recorded in the book Rihla (The Journey) provide an accurate account of the world that he inhabited seven centuries ago. [1]

This supplement of the Indian Journal of Endocrinology and Metabolism traces Ibn Battuta's trail in ways more than one. The huge geographical spread of the articles mentioned in this issue corresponds to his epic journey. The number of subjects studied, the number of clinical trial sites and countries represented, remind us of Ibn Battuta's travels. The sheer number of original papers, and the amount of data presented, try to live up to the voluminous Rihla. The wide spectrum of analyses reported upon the full variety of insulin analogues used in this trial seem similar to the equally vast cultures reported by Ibn Battuta long ago.

Observational studies are non-interventional studies that are conducted to ascertain the efficacy and safety of therapies in the post-marketing period. The main feature of these studies is to collect safety data in a large cohort of patients as a representative of the whole population. [2] Just as Ibn Battuta's observations give us an accurate, vivid account of life in his times, observational studies today describe the real-life picture of health and disease.

While observational studies have been carried out with insulin analogues there has been no large scale study with all three viz., basal, bolus and premix insulin analogues. A 1 chieve study was a 24-week, international, prospective, multicentre, non-randomized, observational study in type 2 diabetes mellitus (T2DM) patients, which evaluated safety and effectiveness of insulin analogues viz., insulin aspart (NovoRapid ® , Novo Nordisk), insulin detemir (Levemir ® , Novo Nordisk, Denmark) and biphasic insulin aspart 30 (NovoMix 30 ® , Novo Nordisk), alone or in combination with OADs in routine clinical practice. The A 1 chieve study was carried out in more than 60,000 patients from 28 countries across four continents (Asia, Africa, Latin America and Europe). The robust methodology and statistical analysis, coupled with the Brobdingnagian subject pool, has made the A 1 chieve study a landmark in modern diabetology.

This Afro-Asian results supplement details the results from 43 regions of India, the Arabian Gulf, Morocco, Tunisia and Libya. This editorial describes, in brief, the methodology of A 1 chieve study. [3] This applies to the study conducted across the nations and continents. The study was conducted in accordance with the principles of declaration of Helsinki and good clinical practice (GCP) guidelines. Before the commencement of the study, ethics committee approval and informed consent from all participants, was obtained.

Patients with type 2 diabetes who had not used any of the study insulin's previously, and who had been started on one of the study insulin's or excipients within past 4 weeks of study commencement, were recruited. People with hypersensitivity to study insulin's and women who were either pregnant or breast feeding or planning to conceive within 6 months of the study, were excluded. Participants were free to withdraw at any time during the study. If they withdrew, the data collected was used for analysis until the point when consent was withdrawn.

The primary objective was to assess number of serious adverse drug reactions (SADRs) including major hypoglycemic events recorded from baseline to final visit. All serious adverse events (SAEs) and adverse drug reactions (ADRs) were also recorded. An ADR was defined as an adverse event for which the reporting physician suspected a possible or probable relationship to a study drug. Minor hypoglycaemic episodes and nocturnal hypoglycaemia were also assessed. Major hypoglycaemic events were defined as events with severe central nervous system symptoms, consistent with hypoglycaemia, for which the person was unable to self-treat, and accompanied by plasma glucose < 3.1 mmol/L or 56 mg/dL, or reversal of symptoms after either food intake or glucagon or intravenous glucose administration. Minor hypoglycaemia was any event, with or without symptoms of hypoglycaemia, with a plasma glucose reading below 3.1 mmol/L or 56 mg/dL and the participant was able to self-treat. Nocturnal hypoglycaemia was defined as a symptomatic event consistent with hypoglycaemia that occurred during sleep between bedtime after the evening insulin injection and before getting up in the morning.

Efficacy of the study drugs was determined by measuring change in HbA 1 c, fasting plasma glucose (FPG), and post-prandial glucose at interim visit and final visit compared with baseline. Body weight, blood pressure, and serum lipids were also recorded at final visit to identify any cardiovascular risk. Furthermore, effect on health related quality of life (HRQoL) of the participants was also evaluated.

The insulin therapies were prescribed by the physician in routine clinical practice. The data was collected at baseline, interim (around 12 weeks from baseline) and final (around 24 weeks from baseline) visit. The time period of 4 weeks past baseline visit, was defined as a pre-study period. Data was collected from the physician's clinical notes, and participant's recall and self-monitoring diary/meter at each visit and transferred to a standard case report form (CRF).

HRQoL was measured using the EQ-5D questionnaire at baseline and after 24 weeks of therapy with insulin analogues.

Statistical analyses were performed for the entire cohort and for the entire cohort classified as insulin-naïve or prior insulin users. For the change in hypoglycaemia from baseline, the percentage of patients reporting at least one event was analyzed using Fisher's exact test. The change from baseline in HbA 1 c, FPG, PPPG, SBP, body weight, blood lipids and HRQoL was analyzed using a paired t-test using baseline and end-of-study values. Data analyses were performed by Novo Nordisk using SAS (version 9.1.3).

In this study, we present the data for subgroups having 5 or more patients only.

The aim of A 1 chieve study was not only to focus on the safety and efficacy of study insulin but also to gather data for future health economic analysis. Moreover further analyses may confer benefits to vulnerable population such as the elderly and/or those with co-morbidities since such groups are generally excluded from randomized controlled trials (RCTs).

This supplement of the Indian Journal of Endocrinology and Metabolism is proud to follow in Ibn Battuta's trail, presenting robust multinational data, to a discerning international audience.

 
   References Top

1.Neville CH. The East Coast, Madagascar and the Indian Ocean. In: Roland O, editor. Cambridge History of Africa. Vol. 3. From c. 1050 to c. 1600. Cambridge: Cambridge University Press; 1977. p. 183-231.  Back to cited text no. 1
    
2.Yang W, Zilov A, Soewondo P, Bech OM, Sekkal F, Home PD. Observational studies: Going beyond the boundaries of randomized controlled trials. Diabetes Res Clin Pract 2010;88 Suppl 1:S3-9.  Back to cited text no. 2
    
3.Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve study: A 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract 2010;88 Suppl 1:S11-6.  Back to cited text no. 3
    




 

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