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
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/m2 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/m2 or weight loss of 3 kg for patients with BMI ≥ 27 kg/m2. 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/m2 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.
Document Type: Research Article
Affiliations: 1: Iuliu Hatieganu, University of Medicine, Cluj Napoca, Romania 2: General Hospital, Novo Mesto, Slovenia 3: Vuk Vrhovac, University Clinic, Zagreb, Croatia 4: Endocrinology Research Center, Moscow, Russia 5: sanofi-aventis, Paris, France 6: Hopital de la Pitie, Paris, France
Publication date: April 1, 2009