TY - JOUR
T1 - Intensive therapy in newly diagnosed type 2 diabetes
T2 - Results of a 6-year randomized trial
AU - Harrison, Lindsay B.
AU - Huet, Beverley A
AU - Li, Xilong
AU - Raskin, Philip
AU - Lingvay, Ildiko
N1 - Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2014/4
Y1 - 2014/4
N2 - Background: This study aimed to assess the efficacy of early intensive diabetes therapy with either insulin plus metformin (INS) or triple oral therapy (TOT) with metformin, glyburide, and pioglitazone on glycemic control and β-Cell function. Methods: Fifty-eight treatment-naive newly diagnosed patients with type 2 diabetes underwent a 3-month lead-in treatment period with insulin and metformin, then were randomized to INS or TOT for 6 years. β-Cell function was measured using mixed-meal challenge test. β-Cell function remained stable throughout the 6-year study in both groups, as measured by the C-peptide area under the curve (AUC; P = 0.13), the AUC C-peptide/AUC glucose (P = 0.9), and by the disposition index (P = 0.8). Excellent glycemic control was maintained in both groups (end-of-study hemoglobinA1c, 7.3% [SD, 1.7%] INS vs 6.4% [1.4%] TOT; P = 0.4). There were 8 treatment failures (confirmed hemoglobinA1c, 98%) in INS and 6 in TOT (P = 0.93). The predictors of treatment failure included higher fasting glucose (P = 0.008), fasting C-peptide (P = 0.008), systolic blood pressure (P = 0.004), and lower insulin sensitivity (P = 0.04) at randomization. Conclusions: Early intensive treatment at the time of type 2 diabetes diagnosisVinitial short-term insulin treatment followed by either insulinbased or intensive oral hypoglycemic-based therapyVstabilizes β-Cell function for at least 6 years. Treatment failure was independent of intervention and was associated with worse disease pathology at baseline.
AB - Background: This study aimed to assess the efficacy of early intensive diabetes therapy with either insulin plus metformin (INS) or triple oral therapy (TOT) with metformin, glyburide, and pioglitazone on glycemic control and β-Cell function. Methods: Fifty-eight treatment-naive newly diagnosed patients with type 2 diabetes underwent a 3-month lead-in treatment period with insulin and metformin, then were randomized to INS or TOT for 6 years. β-Cell function was measured using mixed-meal challenge test. β-Cell function remained stable throughout the 6-year study in both groups, as measured by the C-peptide area under the curve (AUC; P = 0.13), the AUC C-peptide/AUC glucose (P = 0.9), and by the disposition index (P = 0.8). Excellent glycemic control was maintained in both groups (end-of-study hemoglobinA1c, 7.3% [SD, 1.7%] INS vs 6.4% [1.4%] TOT; P = 0.4). There were 8 treatment failures (confirmed hemoglobinA1c, 98%) in INS and 6 in TOT (P = 0.93). The predictors of treatment failure included higher fasting glucose (P = 0.008), fasting C-peptide (P = 0.008), systolic blood pressure (P = 0.004), and lower insulin sensitivity (P = 0.04) at randomization. Conclusions: Early intensive treatment at the time of type 2 diabetes diagnosisVinitial short-term insulin treatment followed by either insulinbased or intensive oral hypoglycemic-based therapyVstabilizes β-Cell function for at least 6 years. Treatment failure was independent of intervention and was associated with worse disease pathology at baseline.
KW - Glycemic control
KW - Hypoglycemia
KW - Insulin resistance
KW - Insulin treatment
KW - Mixed-meal challenge test
KW - Quality of life
KW - Triple oral hypoglycemic therapy
KW - Type 2 diabetes
KW - Weight gain
KW - β-cell function
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U2 - 10.2310/JIM.0000000000000068
DO - 10.2310/JIM.0000000000000068
M3 - Article
C2 - 24569485
AN - SCOPUS:84902134777
VL - 62
SP - 676
EP - 686
JO - Journal of Investigative Medicine
JF - Journal of Investigative Medicine
SN - 1081-5589
IS - 4
ER -