PMID- 22958426
OWN - NLM
STAT- MEDLINE
DCOM- 20130802
LR  - 20181202
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 15
IP  - 3
DP  - 2013 Mar
TI  - Efficacy and tolerability of taspoglutide versus pioglitazone in subjects with 
      type 2 diabetes uncontrolled with sulphonylurea or sulphonylurea-metformin 
      therapy: a randomized, double-blind study (T-emerge 6).
PG  - 234-40
LID - 10.1111/dom.12009 [doi]
AB  - AIMS: This study compared the efficacy and tolerability of taspoglutide versus 
      pioglitazone in subjects with type 2 diabetes inadequately controlled with 
      sulphonylurea +/- metformin. METHODS: In this double-blind, double-dummy, 
      parallel-group trial, 760 subjects (49% male, age 56.4 years, diabetes duration 
      8.8 years, body mass index 32.7 kg/m(2) and haemoglobin A1c [HbA1c] 8.3%) were 
      randomized (1 : 1 : 1) to subcutaneous injections of taspoglutide 10 or 20 mg 
      once weekly or oral pioglitazone 45 mg daily. The primary endpoint was change in 
      HbA1c after 24 weeks. RESULTS: Mean (+/-s.e.) HbA1c reductions with taspoglutide 10 
      (-1.18 +/- 0.08%) and 20 mg (-1.36 +/- 0.08%) were non-inferior to pioglitazone 
      (-1.30 +/- 0.08%) (p = 0.21 and 0.37, respectively); mean treatment differences 
      were 0.12 (95% confidence interval: -0.03, -0.26) and -0.06 (-0.20, 0.08) for 
      taspoglutide 10 and 20 mg versus pioglitazone. Mean (+/-s.e.) changes in body 
      weight (kg) were -0.8 +/- 0.3, -1.0 +/- 0.3 and 3.6 +/- 0.3 for taspoglutide 10 and 20 
      mg and pioglitazone, respectively; 8, 11 and 1% of patients achieved >/=5% weight 
      loss. A higher incidence of adverse events (AEs) occurred with taspoglutide, 
      predominantly gastrointestinal disturbances and injection-site reactions, 
      resulting in higher rates of discontinuation versus pioglitazone. No treatment 
      differences in serious AEs were observed. CONCLUSIONS: Taspoglutide offered good 
      glycaemic control similar to pioglitazone, while achieving beneficial weight loss 
      rather than weight gain, but was associated with more AEs. Due to the higher than 
      expected discontinuation rates, mainly because of gastrointestinal 
      intolerability, the taspoglutide clinical programme was stopped.
CI  - (c) 2012 Blackwell Publishing Ltd.
FAU - Pratley, R E
AU  - Pratley RE
AD  - Florida Hospital - Sanford-Burnham Translational Research Institute for 
      Metabolism and Diabetes, Orlando, FL, USA. richard.pratley@flhosp.org
FAU - Urosevic, D
AU  - Urosevic D
FAU - Boldrin, M
AU  - Boldrin M
FAU - Balena, R
AU  - Balena R
CN  - T-emerge 6 Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120930
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Peptides)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (Thiazolidinediones)
RN  - 2PHK27IP3B (taspoglutide)
RN  - 9100L32L2N (Metformin)
RN  - X4OV71U42S (Pioglitazone)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Blood Glucose/drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dizziness/chemically induced
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Metformin/administration & dosage/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Peptides/administration & dosage/adverse effects/*therapeutic use
MH  - Pioglitazone
MH  - Sulfonylurea Compounds/administration & dosage/adverse effects/*therapeutic use
MH  - Thiazolidinediones/administration & dosage/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2012/09/11 06:00
MHDA- 2013/08/03 06:00
CRDT- 2012/09/11 06:00
PHST- 2012/03/26 00:00 [received]
PHST- 2012/05/02 00:00 [revised]
PHST- 2012/09/02 00:00 [accepted]
PHST- 2012/09/11 06:00 [entrez]
PHST- 2012/09/11 06:00 [pubmed]
PHST- 2013/08/03 06:00 [medline]
AID - 10.1111/dom.12009 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2013 Mar;15(3):234-40. doi: 10.1111/dom.12009. Epub 2012 Sep 
      30.