PMID- 19461584
OWN - NLM
STAT- MEDLINE
DCOM- 20100331
LR  - 20221207
IS  - 1930-739X (Electronic)
IS  - 1930-7381 (Linking)
VI  - 18
IP  - 1
DP  - 2010 Jan
TI  - Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, 
      placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat 
      (Xenical).
PG  - 108-15
LID - 10.1038/oby.2009.155 [doi]
AB  - 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.
FAU - Kopelman, Peter
AU  - Kopelman P
AD  - St Georges, University of London, London, UK.
FAU - Groot, Gerrit de H
AU  - Groot Gde H
FAU - Rissanen, Aila
AU  - Rissanen A
FAU - Rossner, Stephan
AU  - Rossner S
FAU - Toubro, Soren
AU  - Toubro S
FAU - Palmer, Richard
AU  - Palmer R
FAU - Hallam, Rob
AU  - Hallam R
FAU - Bryson, Andrew
AU  - Bryson A
FAU - Hickling, Roger I
AU  - Hickling RI
LA  - eng
SI  - ClinicalTrials.gov/NCT00156897
SI  - ISRCTN/ISRCTN62647464
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20090521
PL  - United States
TA  - Obesity (Silver Spring)
JT  - Obesity (Silver Spring, Md.)
JID - 101264860
RN  - 0 (Benzoxazines)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Lactones)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 9100L32L2N (Metformin)
RN  - 95M8R751W8 (Orlistat)
RN  - EC 3.1.1.3 (Lipase)
RN  - LC5G1JUA39 (cetilistat)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Benzoxazines/*therapeutic use
MH  - Diabetes Mellitus, Type 2/*complications/drug therapy/metabolism
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Glycated Hemoglobin/*metabolism
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Intention to Treat Analysis
MH  - Lactones/*therapeutic use
MH  - Lipase/antagonists & inhibitors
MH  - Male
MH  - Metformin/therapeutic use
MH  - Middle Aged
MH  - Obesity/complications/*drug therapy/metabolism
MH  - Orlistat
MH  - Patient Selection
MH  - Treatment Outcome
MH  - Weight Loss/*drug effects
EDAT- 2009/05/23 09:00
MHDA- 2010/04/01 06:00
CRDT- 2009/05/23 09:00
PHST- 2009/05/23 09:00 [entrez]
PHST- 2009/05/23 09:00 [pubmed]
PHST- 2010/04/01 06:00 [medline]
AID - oby2009155 [pii]
AID - 10.1038/oby.2009.155 [doi]
PST - ppublish
SO  - Obesity (Silver Spring). 2010 Jan;18(1):108-15. doi: 10.1038/oby.2009.155. Epub 
      2009 May 21.