PMID- 19125992
OWN - NLM
STAT- MEDLINE
DCOM- 20090515
LR  - 20221207
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Linking)
VI  - 63
IP  - 1
DP  - 2009 Jan
TI  - Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to 
      metformin therapy in patients with type 2 diabetes inadequately controlled with 
      metformin monotherapy: a multicentre, randomised, double-blind, 
      placebo-controlled study.
PG  - 46-55
LID - 10.1111/j.1742-1241.2008.01933.x [doi]
AB  - AIMS: To evaluate the efficacy and safety of alogliptin, a new dipeptidyl 
      peptidase-4 inhibitor, for 26 weeks at once-daily doses of 12.5 and 25 mg in 
      combination with metformin in patients whose HbA(1c) levels were inadequately 
      controlled on metformin alone. METHODS AND PATIENTS: Patients with type 2 
      diabetes and inadequate glycaemic control (HbA(1c) 7.0-10.0%) were randomised to 
      continue a stable daily metformin dose regimen (> or = 1500 mg) plus the addition 
      of placebo (n = 104) or alogliptin at once-daily doses of 12.5 (n = 213) or 25 mg 
      (n = 210). HbA(1c), insulin, proinsulin, C-peptide and fasting plasma glucose 
      (FPG) concentrations were determined over a period of 26 weeks. RESULTS: 
      Alogliptin at either dose produced least squares mean (SE) decreases from 
      baseline in HbA(1c) of -0.6 (0.1)% and in FPG of -17.0 (2.5) mg/dl [-1.0 (0.1) 
      mmol/l], decreases that were significantly (p < 0.001) greater than those 
      observed with placebo. The between treatment differences (alogliptin - placebo) 
      in FPG reached statistical significance (p < 0.001) as early as week 1 and 
      persisted for the duration of the study. Overall, adverse events (AEs) observed 
      with alogliptin were not substantially different from those observed with 
      placebo. This includes low event rates for gastrointestinal side effects and 
      hypoglycaemic episodes. There was no dose-related pattern of AE reporting between 
      alogliptin groups and few serious AEs were reported. CONCLUSION: Alogliptin is an 
      effective and safe treatment for type 2 diabetes when added to metformin for 
      patients not sufficiently controlled on metformin monotherapy.
FAU - Nauck, M A
AU  - Nauck MA
AD  - Diabeteszentrum Bad Lauterberg im Harz, Bad Lauterberg, Germany. 
      nauck@diabeteszentrum.de
FAU - Ellis, G C
AU  - Ellis GC
FAU - Fleck, P R
AU  - Fleck PR
FAU - Wilson, C A
AU  - Wilson CA
FAU - Mekki, Q
AU  - Mekki Q
CN  - Alogliptin Study 008 Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00286442
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Piperidines)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 56HH86ZVCT (Uracil)
RN  - 9100L32L2N (Metformin)
RN  - JHC049LO86 (alogliptin)
SB  - IM
MH  - Aged
MH  - Blood Glucose/*drug effects
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Metformin/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Piperidines/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Uracil/administration & dosage/adverse effects/*analogs & derivatives
EDAT- 2009/01/08 09:00
MHDA- 2009/05/16 09:00
CRDT- 2009/01/08 09:00
PHST- 2009/01/08 09:00 [entrez]
PHST- 2009/01/08 09:00 [pubmed]
PHST- 2009/05/16 09:00 [medline]
AID - IJCP1933 [pii]
AID - 10.1111/j.1742-1241.2008.01933.x [doi]
PST - ppublish
SO  - Int J Clin Pract. 2009 Jan;63(1):46-55. doi: 10.1111/j.1742-1241.2008.01933.x.