PMID- 24482985
OWN - NLM
STAT- MEDLINE
DCOM- 20140403
LR  - 20221207
IS  - 0004-5772 (Print)
IS  - 0004-5772 (Linking)
VI  - 61
IP  - 1 Suppl
DP  - 2013 Jan
TI  - Improvement of glycemic control with addition of insulin detemir to existing 
      antidiabetic therapy: a sub-group analysis of A1chieve observational study.
PG  - 28-30
AB  - BACKGROUND: The A1chieve study evaluated safety and effectiveness of insulin 
      analogues in a large and diverse population. This report presents a subgroup 
      analysis of the A1chieve observational study pertaining to India. OBJECTIVE: To 
      assess safety and effectiveness of initiation or intensification of insulin 
      detemir in patients with type 2 diabetes mellitus (T2DM) not achieving adequate 
      glycemic control. METHODS: The A1chieve study was a prospective, multi-center, 
      open-label, non-interventional study of 24-weeks duration. In this post-hoc 
      analysis, Indian patients with T2DM who did not achieve their glycemic targets, 
      and were started with or switched to insulin detemir, were evaluated at baseline 
      and after 24 weeks of therapy for safety and effectiveness. Adverse events (AE) 
      noted during the course of therapy were recorded. Additionally Glycemic, 
      non-glycemic parameters and quality of life indices were reported. Appropriate 
      statistical analysis was carried out to assess the statistical significance. 
      RESULTS: The Indian cohort of 2707 patients with T2DM treated with insulin 
      detemir included 2336 (86.29%) insulin-naive and 371 (13.71%) insulin-experienced 
      patients. No adverse drug reaction (ADR) was noted over 24 weeks, one patient 
      (out of 2707) reported serious adverse event. Major hypoglycemia was reported in 
      0.5% (0.08 events/patient year) patients and reduced to 0% (0 events/patient 
      year) over 24 weeks. After 24 weeks' treatment with insulin detemir, an overall 
      reduction in HbA(1c) of 2.1% was noted (p < 0.001), with a 2.1% (p < 0.001) and 
      2% (p < 0.001) reduction in insulin-naive and insulin-experienced groups, 
      respectively. A significant reduction in fasting ([mean +/- SD] -3.8 +/- 2.5 
      mmol/L) and postprandial (-5.2 +/- 3.9 mmol/L) blood glucose (FPG and PPG) was 
      also observed (p < 0.001 for both). At end of the study, 24.4% patients achieved 
      the ADA target of < 7.0% and 14.3% patients achieved the AACE target of < 6.5% 
      for HbA(1c). A significant improvement in quality of life indices like ED-5D 
      (0.31 +/- 0.29; p < 0.001) and EQ-VAS (21.7 +/- 16.7; p < 0.001) was noticed. 
      CONCLUSION: In patients with T2DM not achieving their glycemic targets addition 
      of basal insulin detemir was well tolerated and reported improvement in glycemic 
      control.
FAU - Kesavadev, Jothydev
AU  - Kesavadev J
AD  - Jothydev's Diabetes Research Centre, Trivandrum 695032, Kerala.
FAU - Joshi, Shashank R
AU  - Joshi SR
AD  - Department of Endocrinology, Lilavati Hospital, Mumbai.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - India
TA  - J Assoc Physicians India
JT  - The Journal of the Association of Physicians of India
JID - 7505585
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin, Long-Acting)
RN  - 4FT78T86XV (Insulin Detemir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - India
MH  - Insulin Detemir
MH  - Insulin, Long-Acting/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
EDAT- 2014/02/04 06:00
MHDA- 2014/04/04 06:00
CRDT- 2014/02/04 06:00
PHST- 2014/02/04 06:00 [entrez]
PHST- 2014/02/04 06:00 [pubmed]
PHST- 2014/04/04 06:00 [medline]
PST - ppublish
SO  - J Assoc Physicians India. 2013 Jan;61(1 Suppl):28-30.