PMID- 22608106
OWN - NLM
STAT- MEDLINE
DCOM- 20121011
LR  - 20181201
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 34
IP  - 6
DP  - 2012 Jun
TI  - Long-term effects of adding exenatide to a regimen of metformin and/or 
      sulfonylurea in type 2 diabetes: an uncontrolled, open-label trial in Hungary.
PG  - 1301-13
LID - 10.1016/j.clinthera.2012.04.022 [doi]
AB  - BACKGROUND: Studies of the glucagon-like peptide-1 receptor agonists (GLP-1RAs) 
      are needed to determine the durability of metabolic response and tolerability 
      associated with long-term treatment. OBJECTIVE: The present study was conducted 
      to provide long-term data on glycemic control, weight changes, and tolerability 
      of exenatide 10 mug BID treatment in patients with type 2 diabetes mellitus who 
      have failed to achieve glycemic targets with oral antihyperglycemic medication. 
      METHODS: In this uncontrolled, open-label trial with treatment up to 156 weeks, 
      patients received exenatide 10 mug BID while continuing treatment with metformin 
      and/or a sulfonylurea (SFU). Intent-to-treat (ITT), 52-, 100-, and 132-week 
      completer populations were defined. Metabolic changes were analyzed in the 
      completer and ITT populations; adverse events (AEs) were summarized in the ITT 
      population. Descriptive statistics were used for absolute and 
      change-from-baseline data. Within-treatment comparisons were conducted using the 
      paired t test. RESULTS: Of 155 patients in the ITT population (mean [SD]: age, 59 
      [9] years; 56% female; duration of diabetes, 9.1 [5.9] years; weight, 88.8 [16.5] 
      kg; body mass index, 31.9 [4.7] kg/m(2); hemoglobin [Hb] A(1c), 8.7% [1.2%]), 
      133, 111, and 103 patients completed 52, 100, and 132 weeks of treatment, 
      respectively. In the ITT population, the mean (SE) change in HbA(1c) from 
      baseline to week 132 was -1.0% (0.10%) (P < 0.0001). In patients completing 52, 
      100, and 132 weeks, HbA(1c) changes from baseline to end point were -1.3% 
      (0.10%), -1.0% (0.12%), and -1.0 (0.13%) (P < 0.0001), with 40% of patients 
      achieving HbA(1c) <7% at 132 weeks. Patients in the ITT and completer populations 
      experienced mean (SE) weight changes of -3.7 (0.39) kg and -3.9 (0.51) kg (P < 
      0.0001) at week 132. Improved glycemic control and weight loss occurred in 63% of 
      patients in the completer population at week 132. In addition, 38% of completers 
      at week 132 achieved HbA(1c) <7% without weight gain. No relationship was found 
      between the development of antiexenatide antibodies and change in HbA(1c). The 
      most common AEs were gastrointestinal in nature, reported in 46% of patients and 
      leading to discontinuation in 7 cases. Serious AEs were reported in 26% of 
      patients, and 18% withdrew due to a treatment-emergent AE. Of 24% of patients in 
      whom hypoglycemia was reported, 22% were on SFU or metformin + SFU combination, 
      and 2% were on metformin. CONCLUSIONS: The findings from this open-label, 
      single-arm study characterized the response to exenatide 10 mug BID for up to 132 
      weeks. Significant, persistent improvements in HbA(1c) and weight were observed 
      in patients receiving exenatide BID, with reported AEs consistent with those from 
      studies of shorter duration. ClinicalTrials.gov identifier: NCT00044668.
CI  - Copyright (c) 2012 Elsevier HS Journals, Inc. All rights reserved.
FAU - Ivanyi, Tibor
AU  - Ivanyi T
AD  - European Medical Organization, Eli Lilly and Company, Vienna, Austria. 
      ivanyi_tibor@lilly.com
FAU - Fovenyi, Jozsef
AU  - Fovenyi J
FAU - Faludi, Peter
AU  - Faludi P
FAU - Han, Jenny
AU  - Han J
FAU - Macconell, Leigh
AU  - Macconell L
FAU - Wille, Simone
AU  - Wille S
FAU - Kiljanski, Jacek
AU  - Kiljanski J
LA  - eng
SI  - ClinicalTrials.gov/NCT00044668
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20120516
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Lipids)
RN  - 0 (Peptides)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (Venoms)
RN  - 9100L32L2N (Metformin)
RN  - 9P1872D4OL (Exenatide)
SB  - IM
MH  - Blood Glucose/analysis
MH  - Body Weight
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Drug Therapy, Combination
MH  - Exenatide
MH  - Female
MH  - Humans
MH  - Hungary
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Lipids/blood
MH  - Male
MH  - Metformin/administration & dosage/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Peptides/administration & dosage/adverse effects/*therapeutic use
MH  - Sulfonylurea Compounds/administration & dosage/adverse effects/*therapeutic use
MH  - Venoms/administration & dosage/adverse effects/*therapeutic use
EDAT- 2012/05/23 06:00
MHDA- 2012/10/12 06:00
CRDT- 2012/05/22 06:00
PHST- 2011/12/24 00:00 [received]
PHST- 2012/04/19 00:00 [revised]
PHST- 2012/04/20 00:00 [accepted]
PHST- 2012/05/22 06:00 [entrez]
PHST- 2012/05/23 06:00 [pubmed]
PHST- 2012/10/12 06:00 [medline]
AID - S0149-2918(12)00286-X [pii]
AID - 10.1016/j.clinthera.2012.04.022 [doi]
PST - ppublish
SO  - Clin Ther. 2012 Jun;34(6):1301-13. doi: 10.1016/j.clinthera.2012.04.022. Epub 
      2012 May 16.