PMID- 19087105 OWN - NLM STAT- MEDLINE DCOM- 20100122 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 11 IP - 4 DP - 2009 Apr TI - 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. PG - 379-86 LID - 10.1111/j.1463-1326.2008.00980.x [doi] AB - 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/m2 and A1c 7-8%, treated with maximum doses of metformin and sulphonylurea for > or = 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 > or = 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. FAU - Blickle, J-F AU - Blickle JF AD - Hopitaux Universitaires de Strasbourg, France. Jean-Frederic.Blickle@chru-strasbourg.fr FAU - Hancu, N AU - Hancu N FAU - Piletic, M AU - Piletic M FAU - Profozic, V AU - Profozic V FAU - Shestakova, M AU - Shestakova M FAU - Dain, M-P AU - Dain MP FAU - Jacqueminet, S AU - Jacqueminet S FAU - Grimaldi, A AU - Grimaldi A LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20081214 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (Insulin, Long-Acting) RN - 0 (hemoglobin A1c protein, human) RN - 2ZM8CX04RZ (Insulin Glargine) SB - IM MH - Adult MH - Aged MH - Blood Glucose/*metabolism MH - Combined Modality Therapy MH - Diabetes Mellitus, Type 2/blood/*drug therapy/therapy MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Glycated Hemoglobin/metabolism MH - Humans MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use MH - Insulin/administration & dosage/adverse effects/*analogs & derivatives/therapeutic use MH - Insulin Glargine MH - Insulin, Long-Acting MH - *Life Style MH - Middle Aged MH - Treatment Outcome EDAT- 2008/12/18 09:00 MHDA- 2010/01/23 06:00 CRDT- 2008/12/18 09:00 PHST- 2008/12/18 09:00 [entrez] PHST- 2008/12/18 09:00 [pubmed] PHST- 2010/01/23 06:00 [medline] AID - DOM980 [pii] AID - 10.1111/j.1463-1326.2008.00980.x [doi] PST - ppublish SO - Diabetes Obes Metab. 2009 Apr;11(4):379-86. doi: 10.1111/j.1463-1326.2008.00980.x. Epub 2008 Dec 14.