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GOAL study: clinical and non-clinical predictive factors for achieving glycemic control in people with type 2 diabetes in real clinical practice
  1. Abdulqawi Al Mansari1,
  2. Youssef Obeid2,
  3. Najmul Islam3,
  4. Mohammed Fariduddin4,
  5. Ahmed Hassoun5,
  6. Khier Djaballah6,
  7. Mojtaba Malek7,
  8. Dror Dicker8,
  9. Tirthankar Chaudhury9
  1. 1 Department of Endocrinolog, Erfan Hospital, Jeddah, Saudi Arabia
  2. 2 Department of Endocrinology, Zalka, Haroun Hospital, Beirut, Lebanon
  3. 3 Section of Diabetes, Endocrinology & Metabolism, Department of Medicine, The Aga Khan University Hospital, Karachi, Pakistan
  4. 4 Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  5. 5 Department of Endocrinology, Dubai Diabetes Center, Dubai, UAE
  6. 6 Department of Endocrinology, Sanofi, Paris, France
  7. 7 Department of Endocrinology, Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology & Metabolism, Iran University of Medical Sciences, Tehran, Iran
  8. 8 Department of Endocrinology, Internal Medicine D, Hasharon Hospital Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
  9. 9 Department of Endocrinology, Apollo Gleneagles Hospitals, Kolkata, West Bengal, India
  1. Correspondence to Dr Tirthankar Chaudhury; tchaudhury67{at}yahoo.co.uk

Abstract

Objective The American Diabetes Association and the European Association for the Study of Diabetes guidelines recommend to individualize treatment targets/strategies in inadequately controlled patients by lifestyle management and glucose-lowering drugs to decrease the burden of diabetes-related complications. This real-world practice study aimed to assess predictive factors for achieving the glycemic hemoglobin A1c (HbA1c) at 6 months as targeted by the treating physician in adults with type 2 diabetes who required initiation of basal insulin, initiation of bolus insulin, or modification from basal or premixed insulin to new insulin regimen containing insulin glargine and/or insulin glulisine. 

Research design and methods This was an international, multicenter, observational survey with 12-month follow-up time in adults with type 2 diabetes inadequately controlled conducted in 10 developing countries. 

Results Overall, 2704 patients (mean age: 54.6 years, body mass index: 28.7 kg/m2; Caucasian: 46.1%, type 2 diabetes duration: 10.1 years) with poor glycemic control (mean HbA1c: 9.7% (83 mmol/mol), fasting blood glucose: 196.8 mg/dL) were eligible. At 6 months, advanced age, Caucasian ethnicity, shorter type 2 diabetes duration (>10 vs 1 year, p<0.0001), lower baseline HbA1c (≥ 8.5% vs <7%, p<0.0001) and no intake of oral antidiabetic drug (OAD) (none vs 2, p=0.02) were predictive factors for achieving glycemic goal as targeted by the treating physician. Absolute changes in the mean HbA1c of −1.7% and −2% were observed from baseline to 6 and 12 months, respectively. 

Conclusions Along with some well-known predictive factors, this study suggested that early insulin regimen treatment initiation and/or intensification allowed patients to promote glycemic control.

  • Type 2 Diabetes
  • Insulin
  • glycemic control
  • HbA1c

This is an Open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Presented at Abstract of GOAL study results was published at the 77th American Diabetes Association Scientific session in 9–13 June 2017 (No. 2359-PUB).

  • Contributors All authors were involved in the analysis and interpretation of data, contributed to the discussion and writing of the manuscript, and approved the final version of the article.

  • Funding The study and data analysis was sponsored by Sanofi, Paris, France.

  • Competing interests KD is employee at Sanofi. MF, YO, AAIM, AH and DD were national investigators for the study in their respective countries. AAIM, YO, NI, MF, AH, MM, TC received support from Sanofi to discuss the design, analysis, and interpretation of the study.

  • Patient consent Not required.

  • Ethics approval Ethics approval was obtained from institutional boards of each country.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data statement No additional data available.

  • Author note GOAL (non-interventional on the therapeutic strategy). There was no EUDRACT or NCT number as for clinical trials. Protocol was not disclosed to CT.gov. Study identifications numbers were: ClubNet number (LANTUR06314) and the OPTIMEnumber (OBS13527).