PMID- 20518811
OWN - NLM
STAT- MEDLINE
DCOM- 20110603
LR  - 20131125
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 12
IP  - 6
DP  - 2010 Jun
TI  - Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 
      diabetes: a large observational study.
PG  - 548-51
LID - 10.1111/j.1463-1326.2010.01201.x [doi]
AB  - The objective of this Phase 4, open-label, multicentre, observational study was 
      to fulfil food and drug administration (FDA) postapproval requirement to evaluate 
      in healthcare practices the risk of insulin-induced severe hypoglycaemia 
      following initiation of pramlintide therapy in N = 1297 patients with type 1 
      diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) with inadequate 
      glycaemic control. The duration of the study was approximately 6 months. During 
      the adjustment period (0-3 months), the incidence and event rate of 
      patient-ascertained severe hypoglycaemia (PASH) were 4.8% and 0.33 
      events/patient-year in patients with T1DM and 2.8% and 0.19 events/patient-year 
      in patients with T2DM. During the maintenance period (>3-6 months), the incidence 
      and event rate of PASH declined in patients with T1DM or T2DM. This study 
      confirms that in healthcare practices, the risk of insulin-induced severe 
      hypoglycaemia following the initiation of pramlintide is low in patients with 
      T1DM or T2DM.
FAU - Pencek, R
AU  - Pencek R
FAU - Roddy, T
AU  - Roddy T
FAU - Peters, Y
AU  - Peters Y
FAU - De Young, M B
AU  - De Young MB
FAU - Herrmann, K
AU  - Herrmann K
FAU - Meller, L
AU  - Meller L
FAU - Nguyen, H
AU  - Nguyen H
FAU - Chen, S
AU  - Chen S
FAU - Lutz, K
AU  - Lutz K
LA  - eng
SI  - ClinicalTrials.gov/NCT00229658
PT  - Letter
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Islet Amyloid Polypeptide)
RN  - D3FM8FA78T (pramlintide)
SB  - IM
MH  - Diabetes Mellitus, Type 1/*drug therapy
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/pharmacology/*therapeutic use
MH  - Insulin/*administration & dosage
MH  - Islet Amyloid Polypeptide/*administration & dosage/*adverse effects
MH  - Male
MH  - Postprandial Period
MH  - Treatment Outcome
EDAT- 2010/06/04 06:00
MHDA- 2011/06/04 06:00
CRDT- 2010/06/04 06:00
PHST- 2010/06/04 06:00 [entrez]
PHST- 2010/06/04 06:00 [pubmed]
PHST- 2011/06/04 06:00 [medline]
AID - DOM1201 [pii]
AID - 10.1111/j.1463-1326.2010.01201.x [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2010 Jun;12(6):548-51. doi: 
      10.1111/j.1463-1326.2010.01201.x.