PMID- 27606888 OWN - NLM STAT- MEDLINE DCOM- 20170926 LR - 20231112 IS - 1520-7560 (Electronic) IS - 1520-7552 (Print) IS - 1520-7552 (Linking) VI - 33 IP - 3 DP - 2017 Mar TI - A global study of the unmet need for glycemic control and predictor factors among patients with type 2 diabetes mellitus who have achieved optimal fasting plasma glucose control on basal insulin. LID - 10.1002/dmrr.2858 [doi] LID - e2858 AB - BACKGROUND: This study used data from different sources to identify the extent of the unmet need for postprandial glycemic control in patients with type 2 diabetes mellitus (T2DM) after the initiation of basal insulin therapy in Europe, Asia Pacific, the United States, and Latin America. METHODS: Different levels of evidence were used as available for each country/region, with data extracted from seven randomized controlled trials (RCTs), three clinical trial registries (CTRs), and three electronic medical record (EMR) databases. Glycemic status was categorized as "well controlled" (glycated hemoglobin [HbA(1c) ] at target [<7%]), "residual hyperglycemia" (fasting plasma glucose [FPG] but not HbA(1c) at target [FPG <7.2/7.8 mmol/L, <130/140 mg/dL, depending on country-specific recommendations]), or "uncontrolled" (both FPG and HbA(1c) above target). Predictor factors were identified from the RCT data set using logistic regression analysis. RESULTS: RCT data showed that 16.9% to 28.0%, 42.7% to 54.4%, and 16.9% to 38.1% of patients with T2DM had well-controlled glycemia, residual hyperglycemia, and uncontrolled hyperglycemia, respectively. In CTRs, respective ranges were 21.8% to 33.6%, 31.5% to 35.6%, and 30.7% to 46.8%, and in EMR databases were 4.4% to 21.0%, 23.9% to 31.8%, and 53.6% to 63.8%. Significant predictor factors of residual hyperglycemia identified from RCT data included high baseline HbA(1c) (all countries/regions except Brazil), high baseline FPG (United Kingdom/Japan), longer duration of diabetes (Brazil), and female sex (Europe/Latin America). CONCLUSIONS: Irrespective of intrinsic differences between data sources, 24% to 54% of patients with T2DM globally had residual hyperglycemia with HbA(1c) not at target, despite achieving FPG control, indicating a significant unmet need for postprandial glycemic control. CI - (c) 2016 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons Ltd. FAU - Raccah, Denis AU - Raccah D AD - Department of Diabetology, University Hospital Sainte-Marguerite, Marseille, France. FAU - Chou, Engels AU - Chou E AD - Sanofi R&D, Bridgewater, NJ, USA. FAU - Colagiuri, Stephen AU - Colagiuri S AD - Boden Institute, University of Sydney, Camperdown, NSW, Australia. FAU - Gaal, Zsolt AU - Gaal Z AD - Department of Medicine, Andras Josa Teaching Hospital, Nyiregyhaza, Hungary. FAU - Lavalle, Fernando AU - Lavalle F AD - Servicio de Endocrinologia, Facultad de Medicina UANL, Hospital Universitario, Monterrey, NL, Mexico. FAU - Mkrtumyan, Ashot AU - Mkrtumyan A AD - Moscow State Medical and Stomatological University named after Evdokimov, Moscow, Russian Federation. FAU - Nikonova, Elena AU - Nikonova E AD - Sanofi Global Medical Affairs, Bridgewater, NJ, USA. FAU - Tentolouris, Nikolaos AU - Tentolouris N AD - University of Athens Medical School, Athens, Greece. FAU - Vidal, Josep AU - Vidal J AD - Endocrinology and Nutrition Department, Hospital Clinic, Barcelona, Spain. FAU - Davies, Melanie AU - Davies M AD - Diabetes Research Centre, University of Leicester, Leicester, United Kingdom. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20161013 PL - England TA - Diabetes Metab Res Rev JT - Diabetes/metabolism research and reviews JID - 100883450 RN - 0 (Biomarkers) RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (hemoglobin A1c protein, human) SB - IM MH - Biomarkers/analysis MH - Blood Glucose/metabolism MH - Diabetes Mellitus, Type 2/blood/*drug therapy/epidemiology MH - Fasting/physiology MH - Global Health MH - Glycated Hemoglobin/analysis MH - Humans MH - Hyperglycemia/*prevention & control MH - Hypoglycemic Agents/*therapeutic use MH - Insulin/*therapeutic use MH - *Needs Assessment MH - Prognosis PMC - PMC5347910 OTO - NOTNLM OT - fasting plasma glucose OT - glycemic control OT - insulin therapy OT - postprandial glucose OT - residual hyperglycemia OT - type 2 diabetes mellitus EDAT- 2016/09/09 06:00 MHDA- 2017/09/28 06:00 PMCR- 2017/03/13 CRDT- 2016/09/09 06:00 PHST- 2015/10/23 00:00 [received] PHST- 2016/05/13 00:00 [revised] PHST- 2016/09/04 00:00 [accepted] PHST- 2016/09/09 06:00 [pubmed] PHST- 2017/09/28 06:00 [medline] PHST- 2016/09/09 06:00 [entrez] PHST- 2017/03/13 00:00 [pmc-release] AID - DMRR2858 [pii] AID - 10.1002/dmrr.2858 [doi] PST - ppublish SO - Diabetes Metab Res Rev. 2017 Mar;33(3):e2858. doi: 10.1002/dmrr.2858. Epub 2016 Oct 13.