PMID- 23531118 OWN - NLM STAT- MEDLINE DCOM- 20140519 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 15 IP - 10 DP - 2013 Oct TI - Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. PG - 906-14 LID - 10.1111/dom.12102 [doi] AB - AIM: To prospectively evaluate the efficacy and safety of alogliptin versus glipizide in elderly patients with type 2 diabetes mellitus (T2DM) over 1 year of treatment. METHODS: This was a randomized, double-blind, active-controlled study of elderly T2DM patients (aged 65-90 years) with mild hyperglycaemia on diet/exercise therapy alone [glycosylated haemoglobin (HbA1c) 6.5-9.0%] or plus oral antidiabetic monotherapy (HbA1c 6.5-8.0%). Patients were randomized to once-daily alogliptin 25 mg or glipizide 5 mg titrated to 10 mg, if needed. Hypoglycaemic episodes were systematically captured under predefined criteria. RESULTS: In the primary analysis, HbA1c mean changes from a baseline of 7.5% were -0.14% with alogliptin (n = 222) and -0.09% with glipizide (n = 219) at the end of the study, demonstrating non-inferiority of alogliptin to glipizide [least squares (LS) mean difference = -0.05%; one-sided 97.5% confidence interval (CI): -infinity, 0.13%]. More clinically relevant HbA1c reductions occurred among patients who completed the study: -0.42 and -0.33% with alogliptin and glipizide, with non-inferiority again confirmed (LS mean difference = -0.09%; one-sided 97.5% CI: -infinity, 0.07%). Overall, alogliptin was safe and well tolerated, with notably fewer hypoglycaemic episodes than glipizide [5.4% (31 episodes) vs. 26.0% (232 episodes), respectively]; three patients experienced severe hypoglycaemia, all with glipizide. Alogliptin also resulted in favourable weight changes versus glipizide (-0.62 vs. 0.60 kg at week 52; p < 0.001). CONCLUSIONS: Alogliptin monotherapy maintained glycaemic control comparable to that of glipizide in elderly patients with T2DM over 1 year of treatment, with substantially lower risk of hypoglycaemia and without weight gain. CI - (c) 2013 John Wiley & Sons Ltd. FAU - Rosenstock, J AU - Rosenstock J AD - Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA. FAU - Wilson, C AU - Wilson C FAU - Fleck, P AU - Fleck P LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130418 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Blood Glucose) RN - 0 (Dipeptidyl-Peptidase IV Inhibitors) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Piperidines) RN - 0 (Triglycerides) RN - 0 (hemoglobin A1c protein, human) RN - 56HH86ZVCT (Uracil) RN - 9100L32L2N (Metformin) RN - JHC049LO86 (alogliptin) RN - X7WDT95N5C (Glipizide) SB - IM MH - Aged MH - Aged, 80 and over MH - Blood Glucose/drug effects MH - Diabetes Mellitus, Type 2/blood/*drug therapy/mortality MH - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use MH - Dizziness/chemically induced MH - Double-Blind Method MH - Female MH - Glipizide/adverse effects/*therapeutic use MH - Glycated Hemoglobin/drug effects MH - Headache/chemically induced MH - Humans MH - Hyperglycemia/blood/*drug therapy MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/*therapeutic use MH - Male MH - Metformin/therapeutic use MH - Piperidines/adverse effects/*therapeutic use MH - Prospective Studies MH - Treatment Outcome MH - Triglycerides/blood MH - Uracil/adverse effects/*analogs & derivatives/therapeutic use MH - Weight Gain/drug effects OTO - NOTNLM OT - alogliptin OT - dipeptidyl peptidase-4 inhibitor OT - elderly OT - glipizide OT - hypoglycaemia OT - older OT - prospective OT - type 2 diabetes mellitus EDAT- 2013/03/28 06:00 MHDA- 2014/05/20 06:00 CRDT- 2013/03/28 06:00 PHST- 2012/10/10 00:00 [received] PHST- 2012/11/20 00:00 [revised] PHST- 2013/02/22 00:00 [accepted] PHST- 2013/03/28 06:00 [entrez] PHST- 2013/03/28 06:00 [pubmed] PHST- 2014/05/20 06:00 [medline] AID - 10.1111/dom.12102 [doi] PST - ppublish SO - Diabetes Obes Metab. 2013 Oct;15(10):906-14. doi: 10.1111/dom.12102. Epub 2013 Apr 18.