Linked Life Data

19461584

Source:http://linkedlifedata.com/resource/pubmed/id/19461584

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2009-12-25
pubmed:databankReference
pubmed:abstractText
The objective of this multicenter, randomized, double-blind study was to determine the efficacy and safety of cetilistat and orlistat relative to placebo in obese patients with type 2 diabetes, on metformin. Following a 2-week run-in, patients were randomized to placebo, cetilistat (40, 80, or 120 mg three times daily), or orlistat 120 mg t.i.d., for 12 weeks. The primary endpoint was absolute change in body weight from baseline. Secondary endpoints included other measures of obesity and glycemic control. Similar reductions in body weight were observed in patients receiving cetilistat 80 or 120 mg t.i.d. or 120 mg t.i.d. orlistat; these reductions were significant vs. placebo (3.85 kg, P = 0.01; 4.32 kg, P = 0.0002; 3.78 kg, P = 0.008). In the 40 mg t.i.d. and placebo groups, reductions were 2.94 kg, P = 0.958 and 2.86 kg, respectively. Statistically significant reductions in glycosylated hemoglobin (HbA(1c)) were noted. Cetilistat was well tolerated, and showed fewer discontinuations due to adverse events (AEs) than in the placebo and orlistat groups. Discontinuation in the orlistat group was significantly worse than in the 120 mg cetilistat and placebo groups and was entirely due to gastrointestinal (GI) AEs. Treatment with cetilistat 80 or 120 mg t.i.d., or with orlistat 120 mg t.i.d., significantly reduced body weight and improved glycemic control relative to placebo in obese diabetic patients. Cetilistat was well tolerated with the number of discontinuations due to AEs being similar to placebo.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
1930-7381
pubmed:author
pubmed:issnType
Print
pubmed:volume
18
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
108-15
pubmed:meshHeading
pubmed-meshheading:19461584-Adolescent, pubmed-meshheading:19461584-Adult, pubmed-meshheading:19461584-Aged, pubmed-meshheading:19461584-Benzoxazines, pubmed-meshheading:19461584-Diabetes Mellitus, Type 2, pubmed-meshheading:19461584-Dose-Response Relationship, Drug, pubmed-meshheading:19461584-Double-Blind Method, pubmed-meshheading:19461584-Female, pubmed-meshheading:19461584-Hemoglobin A, Glycosylated, pubmed-meshheading:19461584-Humans, pubmed-meshheading:19461584-Hypoglycemic Agents, pubmed-meshheading:19461584-Intention to Treat Analysis, pubmed-meshheading:19461584-Lactones, pubmed-meshheading:19461584-Lipase, pubmed-meshheading:19461584-Male, pubmed-meshheading:19461584-Metformin, pubmed-meshheading:19461584-Middle Aged, pubmed-meshheading:19461584-Obesity, pubmed-meshheading:19461584-Patient Selection, pubmed-meshheading:19461584-Treatment Outcome, pubmed-meshheading:19461584-Weight Loss
pubmed:year
2010
pubmed:articleTitle
Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat (Xenical).
pubmed:affiliation
St Georges, University of London, London, UK.
pubmed:publicationType
Journal Article, Comparative Study, Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase II