PMID- 24477670 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20140622 LR - 20211021 IS - 1869-6953 (Print) IS - 1869-6961 (Electronic) IS - 1869-6961 (Linking) VI - 5 IP - 1 DP - 2014 Jun TI - Type 2 diabetes mellitus management and body mass index: experiences with initiating insulin detemir in the a1chieve study. PG - 127-40 LID - 10.1007/s13300-014-0054-2 [doi] AB - INTRODUCTION: This sub-analysis of the A1chieve study aimed to examine the safety and efficacy of insulin detemir (IDet) initiation over 24 weeks in relation to baseline body mass index (BMI) in people with type 2 diabetes mellitus (T2DM). METHODS: A1chieve was a 24-week non-interventional study to assess the safety and efficacy of insulin analogs in routine practice. This sub-analysis included insulin-naive patients who initiated IDet therapy based on their physicians' decision. Patients were stratified according to baseline BMI (Group I, <25.0 kg/m(2); Group II, 25.0 to <30.0 kg/m(2); Group III, 30.0 to <35.0 kg/m(2); Group IV >/=35.0 kg/m(2)). Safety and efficacy variables were assessed over 24 weeks. RESULTS: Overall, 10,650 insulin-naive patients were included (3,045 patients in Group I, 4,186 patients in Group II, 2,365 patients in Group III, and 1,054 patients in Group IV). Four serious adverse drug reactions (SADRs) were reported. From baseline to Week 24, there was no statistically significant difference in the proportion of patients reporting overall hypoglycemia in Group I (4.0% vs. 4.4%), while a significant decrease in Group II (4.8% vs. 4.0%, p = 0.0335) and significant increases in Groups III and IV (3.3% vs. 5.4% and 3.4% vs. 7.0%, respectively, p < 0.001) were noted. The mean body weight increased from baseline to Week 24 in Group I (60.7 +/- 8.4 vs. 61.8 +/- 8.5 kg) and reduced in Groups II, III, and IV (74.5 +/- 9.2 vs. 74.2 +/- 9.2 kg, 87.4 +/- 10.3 vs. 86.0 +/- 9.8 kg, and 102.2 +/- 14.3 vs. 100.1 +/- 14.2 kg, respectively; all p < 0.001). Significant improvements were noted in glycemic parameters, systolic blood pressure, and lipids over 24 weeks, irrespective of baseline BMI status. CONCLUSION: IDet therapy was associated with improved glycemic control and a low number of SADRs. Greater weight loss was observed with higher BMI. FAU - Khamseh, Mohammed E AU - Khamseh ME AD - Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran, khamseh.m@iums.ac.ir. FAU - Prusty, Vinay AU - Prusty V FAU - Latif, Zafar AU - Latif Z FAU - Gonzalez-Galvez, Guillermo AU - Gonzalez-Galvez G FAU - Dieuzeide, Guillermo AU - Dieuzeide G FAU - Zilov, Alexey AU - Zilov A LA - eng PT - Journal Article DEP - 20140130 PL - United States TA - Diabetes Ther JT - Diabetes therapy : research, treatment and education of diabetes and related disorders JID - 101539025 PMC - PMC4065301 EDAT- 2014/01/31 06:00 MHDA- 2014/01/31 06:01 PMCR- 2014/01/30 CRDT- 2014/01/31 06:00 PHST- 2013/10/07 00:00 [received] PHST- 2014/01/31 06:00 [entrez] PHST- 2014/01/31 06:00 [pubmed] PHST- 2014/01/31 06:01 [medline] PHST- 2014/01/30 00:00 [pmc-release] AID - 54 [pii] AID - 10.1007/s13300-014-0054-2 [doi] PST - ppublish SO - Diabetes Ther. 2014 Jun;5(1):127-40. doi: 10.1007/s13300-014-0054-2. Epub 2014 Jan 30.