PMID- 21472661
OWN - NLM
STAT- MEDLINE
DCOM- 20111109
LR  - 20141120
IS  - 1439-3646 (Electronic)
IS  - 0947-7349 (Linking)
VI  - 119
IP  - 7
DP  - 2011 Jul
TI  - A Dose-Ranging Study of the DPP-IV Inhibitor PF-734200 Added to Metformin in 
      Subjects With Type 2 Diabetes*.
PG  - 401-7
LID - 10.1055/s-0031-1273737 [doi]
AB  - The purpose of this phase 2, multicentre, randomized, double-blind, 
      placebo-controlled, 12-week dose-ranging study was to assess the efficacy, 
      safety, and tolerability of the dipeptidyl peptidase-IV (DPP-IV) inhibitor 
      PF-734200 in adult subjects with type 2 diabetes who were on a stable dose of 
      metformin. Men and women with inadequate glycaemic control with metformin as 
      their sole diabetes medication were randomized to placebo or PF-734200 2 mg, 5 
      mg, 10 mg, or 20 mg every day. A population subset underwent mixed meal tolerance 
      tests (MMTT) at baseline and week 12. A total of 301 subjects were treated. At 
      week 12, PF-734200 doses of >/=5 mg produced a statistically significant reduction 
      in haemoglobin A (1C) (HbA (1c)) compared with placebo. The mean (95% confidence 
      interval) placebo-adjusted changes in HbA (1c) were -0.31% (-0.70 to 0.08), 
      -0.74% (-1.12 to -0.36), -0.70% (-1.02 to -0.38), and -0.75% (-1.07 to -0.43) for 
      the 2 mg, 5 mg, 10 mg, and 20 mg doses, respectively. PF-734200 20 mg 
      significantly reduced glucose area under the curve following MMTT (-12.8% [-22.9 
      to -2.7]; p=0.003) compared with placebo. The reductions observed with other 
      doses were not statistically significant. PF-734200 was safe and well tolerated 
      at all doses tested when added to metformin. PF-734200 safely and effectively 
      lowered HbA (1c) in subjects receiving metformin. The 20 mg dose provided the 
      greatest improvements in post-prandial glucose.
CI  - (c) J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart . New York.
FAU - Terra, S G
AU  - Terra SG
AD  - Pfizer Global Research and Development, New London, Connecticut, USA. 
      steven.g.terra@pfizer.com
FAU - Somayaji, V
AU  - Somayaji V
FAU - Schwartz, S
AU  - Schwartz S
FAU - Lewin, A J
AU  - Lewin AJ
FAU - Teeter, J G
AU  - Teeter JG
FAU - Dai, H
AU  - Dai H
FAU - Nguyen, T T
AU  - Nguyen TT
FAU - Calle, R A
AU  - Calle RA
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110406
PL  - Germany
TA  - Exp Clin Endocrinol Diabetes
JT  - Experimental and clinical endocrinology & diabetes : official journal, German 
      Society of Endocrinology [and] German Diabetes Association
JID - 9505926
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Protease Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrrolidines)
RN  - 9100L32L2N (Metformin)
RN  - EC 3.4.14.5 (DPP4 protein, human)
RN  - EC 3.4.14.5 (Dipeptidyl Peptidase 4)
RN  - GI718UO477 (gosogliptin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Blood Glucose/metabolism
MH  - Case-Control Studies
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - *Dipeptidyl Peptidase 4
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Metformin/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Protease Inhibitors/*administration & dosage/adverse effects
MH  - Pyrimidines/*administration & dosage/adverse effects
MH  - Pyrrolidines/*administration & dosage/adverse effects
EDAT- 2011/04/08 06:00
MHDA- 2011/11/10 06:00
CRDT- 2011/04/08 06:00
PHST- 2011/04/08 06:00 [entrez]
PHST- 2011/04/08 06:00 [pubmed]
PHST- 2011/11/10 06:00 [medline]
AID - 10.1055/s-0031-1273737 [doi]
PST - ppublish
SO  - Exp Clin Endocrinol Diabetes. 2011 Jul;119(7):401-7. doi: 10.1055/s-0031-1273737. 
      Epub 2011 Apr 6.