PMID- 20536952
OWN - NLM
STAT- MEDLINE
DCOM- 20101105
LR  - 20221207
IS  - 1464-5491 (Electronic)
IS  - 0742-3071 (Print)
IS  - 0742-3071 (Linking)
VI  - 27
IP  - 5
DP  - 2010 May
TI  - Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 
      analogue, in diabetic patients treated with metformin: a randomized double-blind 
      placebo-controlled study.
PG  - 556-62
LID - 10.1111/j.1464-5491.2010.02990.x [doi]
AB  - AIMS: The study objective was to investigate the safety and tolerability of 
      up-titration to high doses of taspoglutide, a once-weekly human glucagon-like 
      peptide-1 analogue, in subjects with Type 2 diabetes inadequately controlled on 
      metformin alone. METHODS: In this double-blind phase II trial, subjects were 
      randomized to placebo or taspoglutide (20 mg; three separate groups) administered 
      once weekly by subcutaneous injection for 4 weeks. This was followed by dose 
      maintenance at 20 mg, or titration to 30 mg (20/30) or 40 mg (20/40) once weekly 
      with matched placebo for an additional 4 weeks. Subjects were monitored for 
      adverse events (AEs) throughout the study and 4-week follow-up. RESULTS: One 
      hundred and twenty-nine subjects were randomized and treated [mean age 57 years, 
      mean baseline glycated haemoglobin (HbA(1c)), 7.9%]. The most frequently reported 
      AEs were nausea and vomiting. The number of patients reporting gastrointestinal 
      AEs did not increase following titration to higher doses of taspoglutide or when 
      continuing the initial 20 mg regimen. Three subjects were withdrawn from the 
      study as a result of gastrointestinal AEs (one before and two after titration to 
      higher doses). Although not designed to investigate efficacy, improvement in 
      glycaemic control was observed in all active arms of the study. The proportion of 
      subjects achieving HbA(1c) < 7.0% after 8 weeks of treatment was 72, 53 and 70% 
      in the 20/20-, 20/30- and 20/40-mg arms, respectively, vs. 19% for placebo. 
      CONCLUSIONS: Taspoglutide was safe, well tolerated at high doses and efficacious 
      for lowering HbA(1c). Up-titration of dose was not associated with a worsening AE 
      profile.
FAU - Ratner, R
AU  - Ratner R
AD  - Medstar Research Institute, Hyattsville, MD, USA.
FAU - Nauck, M
AU  - Nauck M
FAU - Kapitza, C
AU  - Kapitza C
FAU - Asnaghi, V
AU  - Asnaghi V
FAU - Boldrin, M
AU  - Boldrin M
FAU - Balena, R
AU  - Balena R
LA  - eng
SI  - ClinicalTrials.gov/NCT00460941
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Diabet Med
JT  - Diabetic medicine : a journal of the British Diabetic Association
JID - 8500858
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (GLP1R protein, human)
RN  - 0 (Glucagon-Like Peptide-1 Receptor)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Peptides)
RN  - 0 (Receptors, Glucagon)
RN  - 2PHK27IP3B (taspoglutide)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
RN  - 9100L32L2N (Metformin)
SB  - IM
EIN - Diabet Med. 2010 Jun;27(6):732
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced
MH  - Glucagon-Like Peptide 1/administration & dosage/adverse effects/*analogs & 
      derivatives/*therapeutic use
MH  - Glucagon-Like Peptide-1 Receptor
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/*adverse effects/*therapeutic use
MH  - Injections, Subcutaneous
MH  - Male
MH  - Metformin/*therapeutic use
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Peptides/administration & dosage/*adverse effects/*therapeutic use
MH  - Receptors, Glucagon/*antagonists & inhibitors
MH  - Vomiting/chemically induced
PMC - PMC2948428
EDAT- 2010/06/12 06:00
MHDA- 2010/11/06 06:00
CRDT- 2010/06/12 06:00
PHST- 2010/06/12 06:00 [entrez]
PHST- 2010/06/12 06:00 [pubmed]
PHST- 2010/11/06 06:00 [medline]
AID - DME2990 [pii]
AID - 10.1111/j.1464-5491.2010.02990.x [doi]
PST - ppublish
SO  - Diabet Med. 2010 May;27(5):556-62. doi: 10.1111/j.1464-5491.2010.02990.x.