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Insulin glargine provides greater improvements in glycaemic control vs. intensifying lifestyle management for people with type 2 diabetes treated with OADs and 7–8% A1c levels. The TULIP study
Author(s) -
Blicklé JF.,
Hancu N.,
Piletic M.,
Profozic V.,
Shestakova M.,
Dain MP.,
Jacqueminet S.,
Grimaldi A.
Publication year - 2009
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2008.00980.x
Subject(s) - medicine , insulin glargine , type 2 diabetes , body mass index , diabetes mellitus , clinical endpoint , metformin , randomized controlled trial , gastroenterology , insulin , endocrinology
Aim: To determine whether earlier administration of insulin glargine (glargine) vs. the intensification of lifestyle management (LM) improves glycaemic control in type 2 diabetes patients with A1c 7–8% treated with oral therapy. Methods: TULIP [Testing the Usefulness of gLargine when Initiated Promptly in type 2 diabetes mellitus (T2DM)] was a 9‐month, 12‐visit, open‐label, multinational, multicentre, randomized study to evaluate starting glargine or intensifying LM in T2DM patients aged 40–75 years, body mass index (BMI) 24–35 kg/m 2 and A1c 7–8%, treated with maximum doses of metformin and sulphonylurea for ≥ 2 years. Glargine was injected once daily (evening) and titrated to fasting blood glucose 0.7–1.0 g/l. In the LM arm, dietary and physical activity counselling recommended stable weight for people with BMI < 27 kg/m 2 or weight loss of 3 kg for patients with BMI ≥ 27 kg/m 2 . A total of 215 patients were randomized to glargine (n = 106) or LM (n = 109). The primary objective was patients achieving A1c < 7% at endpoint. Secondary endpoints included changes in A1c, in fasting plasma glucose (FPG), body weight and hypoglycaemia incidence. Results: Two hundred and eleven (52.6% male) patients were randomized and treated; mean (± s.d.) age 60.7 ± 7.9 years, weight 84.5 ± 13.1 kg, BMI 29.9 ± 3.5 kg/m 2 and A1c 7.6 ± 0.4%. More patients reached A1c < 7% (66 vs. 38%; p < 0.0001) or < 6.5% (34 vs. 11%; p = 0.0001) with glargine vs. LM. The change in FPG from baseline to study endpoint was significantly greater in the glargine vs. the LM arm (−0.50 ± 0.47 vs. −0.05 ± 0.39 g/l respectively; p < 0.0001). Compared with the glargine group, the LM group showed a decrease in weight (+0.9 ± 2.9 vs. −2.5 ± 3.2 kg; p < 0.0001), as well as the expected lower symptomatic hypoglycaemia (55.3 vs. 25.0%; p < 0.0001) and nocturnal hypoglycaemia (20.4 vs. 5.6%; p = 0.0016). No significant changes were observed from baseline to study endpoint in any of the lipid parameters tested. Conclusions: In patients with T2DM with A1c 7–8%, who were previously treated by conventional LM and OAD therapy, adding glargine resulted in greater improvements in glycaemic control vs. intensifying LM.