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.
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.



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 [HbA1c] at target [<7%]), "residual hyperglycemia" (fasting plasma glucose [FPG] but not HbA1cat target [FPG <7.2/7.8 mmol/L, <130/140 mg/dL, depending on country-specific recommendations]), or "uncontrolled" (both FPG and HbA1cabove target). Predictor factors were identified from the RCT data set using logistic regression analysis.



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 HbA1c(all countries/regions except Brazil), high baseline FPG (United Kingdom/Japan), longer duration of diabetes (Brazil), and female sex (Europe/Latin America).



Irrespective of intrinsic differences between data sources, 24% to 54% of patients with T2DM globally had residual hyperglycemia with HbA1cnot at target, despite achieving FPG control, indicating a significant unmet need for postprandial glycemic control.
Department of Diabetology, University Hospital Sainte-Marguerite, Marseille, France.
Denis
D
Raccah
Sanofi R&D, Bridgewater, NJ, USA.
Engels
E
Chou
Boden Institute, University of Sydney, Camperdown, NSW, Australia.
Stephen
S
Colagiuri
Department of Medicine, András Jósa Teaching Hospital, Nyíregyháza, Hungary.
Zsolt
Z
Gaàl
Servicio de Endocrinología, Facultad de Medicina UANL, Hospital Universitario, Monterrey, NL, Mexico.
Fernando
F
Lavalle
Moscow State Medical and Stomatological University named after Evdokimov, Moscow, Russian Federation.
Ashot
A
Mkrtumyan
Sanofi Global Medical Affairs, Bridgewater, NJ, USA.
Elena
E
Nikonova
University of Athens Medical School, Athens, Greece.
Nikolaos
N
Tentolouris
Endocrinology and Nutrition Department, Hospital Clinic, Barcelona, Spain.
Josep
J
Vidal
Diabetes Research Centre, University of Leicester, Leicester, United Kingdom.
Melanie
M
Davies
D015415:Biomarkers / Q000032:analysis; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D005215:Fasting / Q000502:physiology; D014943:Global Health; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D020380:Needs Assessment; D011379:Prognosis
D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human
fasting plasma glucose; glycemic control; insulin therapy; postprandial glucose; residual hyperglycemia; type 2 diabetes mellitus