PMID- 22974280
OWN - NLM
STAT- MEDLINE
DCOM- 20150223
LR  - 20170203
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 14
IP  - 12
DP  - 2012 Dec
TI  - Linagliptin monotherapy in type 2 diabetes patients for whom metformin is 
      inappropriate: an 18-week randomized, double-blind, placebo-controlled phase III 
      trial with a 34-week active-controlled extension.
PG  - 1145-54
LID - 10.1111/dom.12011 [doi]
AB  - AIMS: To investigate the efficacy and safety of linagliptin, a dipeptidyl 
      peptidase-4 inhibitor, in type 2 diabetes mellitus (T2DM) patients for whom 
      metformin was inappropriate. METHODS: This 1-year double-blind study 
      (ClinicalTrials.gov, NCT00740051) enrolled T2DM patients with inadequate 
      glycaemic control, treatment-naive [glycated haemoglobin (HbA1c) 7.0-10.0%] or 
      previously treated with one oral antidiabetes drug (HbA1c 6.5-9.0% before 
      washout), ineligible for metformin because of contraindications (e.g. renal 
      impairment) or previous intolerable side effects. Patients were randomized to 
      monotherapy with linagliptin 5 mg once daily (n = 151) or placebo (n = 76) for 
      18 weeks, after which placebo patients switched to glimepiride 1-4 mg once daily 
      and treatments continued for another 34 weeks. The primary endpoint was change 
      from baseline in HbA1c after 18 weeks (full-analysis set, last observation 
      carried forward). RESULTS: At week 18, adjusted mean difference in change from 
      baseline HbA1c (8.1%) was -0.60% (95% confidence interval -0.88, -0.32; 
      p < 0.0001) (-0.39% with linagliptin, +0.21% with placebo). At week 52, mean 
      HbA1c was decreased from baseline in both groups [linagliptin: -0.44%; 
      placebo/glimepiride: -0.72% (observed cases)]. Adverse events occurred in 40.4 
      and 48.7% of linagliptin and placebo patients, respectively, during the initial 
      18 weeks. During the 34-week extension, patients receiving linagliptin 
      experienced less hypoglycaemia (2.2% vs. 7.8%) and no weight gain (mean change 
      from baseline of -0.2 and +1.3 kg, respectively) compared with glimepiride 
      patients. CONCLUSIONS: In T2DM patients for whom metformin was inappropriate, 
      linagliptin improved glycaemic control and was well tolerated, with less 
      hypoglycaemia and relative weight loss compared with glimepiride.
CI  - (c) 2012 Blackwell Publishing Ltd.
FAU - Barnett, A H
AU  - Barnett AH
AD  - Diabetes Centre, Heart of England NHS Foundation Trust and University of 
      Birmingham, Birmingham, UK.
FAU - Patel, S
AU  - Patel S
FAU - Harper, R
AU  - Harper R
FAU - Toorawa, R
AU  - Toorawa R
FAU - Thiemann, S
AU  - Thiemann S
FAU - von Eynatten, M
AU  - von Eynatten M
FAU - Woerle, H-J
AU  - Woerle HJ
LA  - eng
SI  - ClinicalTrials.gov/NCT00740051
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121001
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 0 (Sulfonylurea Compounds)
RN  - 3X29ZEJ4R2 (Linagliptin)
RN  - 6KY687524K (glimepiride)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Glucose/*drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Hypoglycemia/chemically induced/*prevention & control
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Linagliptin
MH  - Male
MH  - Metformin/therapeutic use
MH  - Middle Aged
MH  - Purines/*therapeutic use
MH  - Quinazolines/*therapeutic use
MH  - Sulfonylurea Compounds/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - glycaemic control
OT  - incretin therapy
OT  - metformin
OT  - phase III study
OT  - type 2 diabetes
EDAT- 2012/09/15 06:00
MHDA- 2015/02/24 06:00
CRDT- 2012/09/15 06:00
PHST- 2012/07/20 00:00 [received]
PHST- 2012/08/06 00:00 [revised]
PHST- 2012/09/06 00:00 [accepted]
PHST- 2012/09/15 06:00 [entrez]
PHST- 2012/09/15 06:00 [pubmed]
PHST- 2015/02/24 06:00 [medline]
AID - 10.1111/dom.12011 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2012 Dec;14(12):1145-54. doi: 10.1111/dom.12011. Epub 2012 
      Oct 1.