PMID- 25867771
OWN - NLM
STAT- MEDLINE
DCOM- 20151201
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 6
DP  - 2015 Jun
TI  - Vildagliptin versus insulin in patients with type 2 diabetes mellitus 
      inadequately controlled with sulfonylurea: results from a randomized, 24 week 
      study.
PG  - 1079-84
LID - 10.1185/03007995.2015.1039936 [doi]
AB  - OBJECTIVE: There is limited evidence to guide the selection of second-line 
      anti-hyperglycemic agents in patients with type 2 diabetes mellitus (T2DM) who 
      are inadequately controlled with sulfonylurea monotherapy and are intolerant to 
      metformin. We compared the efficacy and safety of vildagliptin 50 mg qd and 
      Neutral Protamine Hagedorn (NPH) insulin qd in such patients. METHODS: This was a 
      24 week, multicenter, randomized, open-label study. The co-primary endpoints were 
      (i) proportion of patients achieving HbA1c <7.0% without any confirmed 
      hypoglycemic events (HEs) or weight gain >/=3% (composite endpoint); (ii) rate of 
      confirmed HEs. Treatment satisfaction was assessed using the TSQM-9 questionnaire 
      at study end. RESULTS: A total of 162 patients were randomly assigned to 
      vildagliptin (n = 83) and NPH insulin (n = 79). Similar proportion of patients 
      achieved the composite endpoint in vildagliptin versus NPH insulin group (35.4% 
      versus 34.2%; OR 0.985; 95% CI 0.507, 1.915; p = 0.96). After 24 weeks, 48.8% of 
      patients in the vildagliptin group and 60.8% in the NPH insulin group achieved 
      HbA1c <7.0%; 13.4% in the vildagliptin group and 29.1% in the insulin group had 
      at least one confirmed HE; while 11.0% in the vildagliptin group and 22.8% in the 
      insulin group experienced weight gain. The rate of confirmed HEs was 
      significantly lower in patients receiving vildagliptin versus NPH insulin (1.3 
      versus 5.1 events per year). The TSQM-9 score for 'convenience' at week 24 
      increased significantly more with vildagliptin than with NPH insulin. 
      CONCLUSIONS: Addition of vildagliptin and NPH insulin resulted in a similar 
      number of patients reaching HbA1c target without HEs or weight gain in T2DM 
      patients inadequately controlled with sulfonylurea. The addition of vildagliptin 
      to sulfonylurea could be considered as a treatment option prior to 
      intensification with insulin, with the advantages of a lower HE rate and greater 
      patient convenience. Study results are limited by a higher drop-out rate in the 
      vildagliptin arm.
FAU - Forst, Thomas
AU  - Forst T
AD  - Profil Mainz GmbH & Co. KG , Mainz , Germany.
FAU - Koch, Cornelia
AU  - Koch C
FAU - Dworak, Markus
AU  - Dworak M
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150520
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 0 (Sulfonylurea Compounds)
RN  - 53027-39-7 (Insulin, Isophane)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/*analogs & derivatives/therapeutic use
MH  - Adult
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin, Isophane/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nitriles/*therapeutic use
MH  - Pyrrolidines/*therapeutic use
MH  - Sulfonylurea Compounds/therapeutic use
MH  - Vildagliptin
MH  - Weight Gain/drug effects
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - Insulin
OT  - Sulfonylurea, Type 2 diabetes mellitus
OT  - Vildagliptin
EDAT- 2015/04/14 06:00
MHDA- 2015/12/15 06:00
CRDT- 2015/04/14 06:00
PHST- 2015/04/14 06:00 [entrez]
PHST- 2015/04/14 06:00 [pubmed]
PHST- 2015/12/15 06:00 [medline]
AID - 10.1185/03007995.2015.1039936 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Jun;31(6):1079-84. doi: 10.1185/03007995.2015.1039936. 
      Epub 2015 May 20.