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 ORIGINAL ARTICLE
Year : 2014  |  Volume : 60  |  Issue : 2  |  Page : 151-155

Correlation between measures of hypoglycemia and glycemic improvement in sulfonylurea treated patients with type 2 diabetes in India: Results from the OBSTACLE hypoglycemia study


1 Department of Endocrinology, Karnal Bharti Hospital, Karnal, Haryana, India
2 Department of Diabetes, Madhav Diabetes Center, Chennai, Tamil Nadu, India
3 Department of Medical Affairs, MSD Pharmaceuticals Pvt Ltd, Lucknow, Uttar Pradesh, India
4 Department of Diabetes, Sri Ramkamal Diabetes and Heart Clinic, Lucknow, Uttar Pradesh, India

Correspondence Address:
Dr. V Singh
Department of Medical Affairs, MSD Pharmaceuticals Pvt Ltd, Lucknow, Uttar Pradesh
India
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Source of Support: The study was sponsored by MSD Pharmaceuticals Private Limited,, Conflict of Interest: Deepak MC, Kalra S, and Maheshwari A are clinicians based in India and were investigators for this study. They have received payments for their services for the current study and have also previously received payments against other scientific services provided to MSD Pharmaceuticals Pvt. Ltd., India. P Narang, and V Singh are full-time employees of MSD Pharmaceuticals Pvt. Ltd., India.


DOI: 10.4103/0022-3859.132322

Clinical trial registration NCT00907881

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Background: This study aimed to assess correlation between measures of hypoglycemia and glycemic control in patients with type 2 diabetes mellitus (T2DM) treated with sulfonylureas. Materials and Methods: T2DM patients being initiated on a sulfonylurea (SU) on background of a failing oral antihyperglycemic regimen were followed up for 12 weeks. (HbA1c) was measured at baseline and end of follow-up. Hypoglycemia was assessed using Stanford Hypoglycemia Questionnaire at week 12. Results: Of the total 1069 patients enrolled, 950 were considered evaluable. A weak negative correlation was observed between end of follow-up HbA1c values and hypoglycemia score, using both linear regression analysis (correlation coefficient -0.12; P = 0.0002) and negative binomial regression (β slope -0.09; P = 0.0010). A similar correlation was also observed between change in HbA1c from baseline and hypoglycemia score (β slope -0.07; P = 0.0048). Mean HbA1c reduction was lowest (0.65 ± 2.27%) in patients not reporting any hypoglycemia and highest (1.28 ± 2.40%) in patients with hypoglycemia score greater than median of 2 (P = 0.0031). There was no correlation between hypoglycemia frequency and end of follow-up HbA1c values (P = 0.4111). Conclusion: With addition of SU on a background of a failing oral anti-hyperglycemic regimen, the extent of glycemic control correlates directly with measures of patient reported hypoglycemia.






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Online since 12th February '04
2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
Published by Wolters Kluwer - Medknow