PMID- 29760944
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220317
IS  - 2055-8260 (Print)
IS  - 2055-8260 (Electronic)
IS  - 2055-8260 (Linking)
VI  - 4
DP  - 2018
TI  - Characteristics of insulin-Naive people with type 2 diabetes who successfully 
      respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of 
      individual participant data from 3 randomized clinical trials.
PG  - 10
LID - 10.1186/s40842-018-0059-2 [doi]
LID - 10
AB  - BACKGROUND: To identify baseline/clinical characteristics associated with 
      clinically meaningful responses to insulin glargine 100 U/mL (IGlar) in 
      insulin-naive people with type 2 diabetes mellitus (T2DM). METHODS: Individual 
      participant data were pooled from 3 randomized trials to compare baseline 
      characteristics and clinical outcomes associated with 24-week response to IGlar 
      in combination with non-insulin antihyperglycemic agents in participants with 
      T2DM. Responders were defined as achieving endpoint HbA1c target < 53 mmol/mol 
      (< 7%) and/or >/= 11 mmol/mol (>/= 1%) HbA1c reduction from baseline. RESULTS: 
      Differences in baseline characteristics for responders versus nonresponders were 
      higher HbA1c (99 vs 91 mmol/mol [9.1 vs 8.3%]; P < 0.001), higher fasting blood 
      glucose (FBG; 10.4 vs 8.8 mmol/L [187 vs 159 mg/dL; P < 0.001), and fewer 
      participants (94% vs 98%; P = 0.006) taking oral medications targeting 
      postprandial blood glucose (BG). Most participants (80%) achieved one or both 
      components of composite endpoint. 12-week response was a strong predictor of 
      subsequent 24-week response (sensitivity, 85.9%; predictive positive value, 
      91.4%). At both 12 and 24 weeks, < 40% of responders and nonresponders reached 
      target FBG </= 5.6 mmol/L (</= 100 mg/dL). Responders at 24 weeks had higher 
      incidence of hypoglycemia (total, 82.5% vs 70.4%; P < 0.001; nocturnal, 60.3% vs 
      50.5%; P = 0.002; documented symptomatic, 65.8% vs 55.6%; P < 0.001) than 
      nonresponders. CONCLUSIONS: Baseline characteristics associated with response 
      were identified. The strong predictability of 12-week response suggests that the 
      magnitude of early HbA1c reduction should be considered when assessing response 
      to IGlar. More aggressive IGlar titration may be reasonable for nonresponders and 
      responders who have not reached FBG and HbA1c targets, taking into account other 
      BG timepoints.
FAU - Cummings, M H
AU  - Cummings MH
AD  - 1Queen Alexandra Hospital, Portsmouth, UK. ISNI: 0000 0004 0392 0072. GRID: 
      grid.415470.3
FAU - Cao, D
AU  - Cao D
AD  - 2Eli Lilly and Company, Indianapolis, IN USA. ISNI: 0000 0000 2220 2544. GRID: 
      grid.417540.3
FAU - Hadjiyianni, I
AU  - Hadjiyianni I
AD  - 3Lilly Deutschland GmbH, Bad Homburg, Germany. ISNI: 0000 0004 0533 9169. GRID: 
      grid.435900.b
FAU - Ilag, L L
AU  - Ilag LL
AUID- ORCID: 0000-0001-8831-9726
AD  - 2Eli Lilly and Company, Indianapolis, IN USA. ISNI: 0000 0000 2220 2544. GRID: 
      grid.417540.3
FAU - Tan, M H
AU  - Tan MH
AD  - 4University of Michigan, Ann Arbor, MI USA. ISNI: 0000000086837370. GRID: 
      grid.214458.e
LA  - eng
PT  - Journal Article
DEP - 20180508
PL  - England
TA  - Clin Diabetes Endocrinol
JT  - Clinical diabetes and endocrinology
JID - 101669619
PMC - PMC5941643
OTO - NOTNLM
OT  - Baseline characteristics
OT  - HbA1c composite endpoint
OT  - Insulin glargine
OT  - Insulin naive
OT  - Responders
OT  - Type 2 diabetes
COIS- Not applicable.MHC has participated in Abasaglar speaker events for which he 
      received honorarium from Eli Lilly and Company and Boehringer-Ingelheim. LLI, DC, 
      and IH are employees of and hold stock in Eli Lilly and Company. MHT is a retiree 
      of Eli Lilly and Company. This study was previously published in part as two 
      abstracts, the first at the American Diabetes Association's 76th Annual 
      Scientific Sessions in New Orleans, LA, USA in June 2016 and the second at 
      Diabetes UK Professional Conference, Manchester, UK in March 2017.Springer Nature 
      remains neutral with regard to jurisdictional claims in published maps and 
      institutional affiliations.
EDAT- 2018/05/16 06:00
MHDA- 2018/05/16 06:01
PMCR- 2018/05/08
CRDT- 2018/05/16 06:00
PHST- 2017/10/27 00:00 [received]
PHST- 2018/04/04 00:00 [accepted]
PHST- 2018/05/16 06:00 [entrez]
PHST- 2018/05/16 06:00 [pubmed]
PHST- 2018/05/16 06:01 [medline]
PHST- 2018/05/08 00:00 [pmc-release]
AID - 59 [pii]
AID - 10.1186/s40842-018-0059-2 [doi]
PST - epublish
SO  - Clin Diabetes Endocrinol. 2018 May 8;4:10. doi: 10.1186/s40842-018-0059-2. 
      eCollection 2018.