PMID- 24186595
OWN - NLM
STAT- MEDLINE
DCOM- 20141201
LR  - 20221207
IS  - 2299-8306 (Electronic)
IS  - 0423-104X (Linking)
VI  - 64
IP  - 5
DP  - 2013
TI  - Exenatide twice daily versus insulin glargine for the treatment of type 2 
      diabetes in Poland - subgroup data from a randomised multinational trial GWAA.
PG  - 375-82
LID - 10.5603/EP.2013.0021 [doi]
AB  - INTRODUCTION: We explored the safety and efficacy of exenatide BID v. insulin 
      glargine in a subgroup of Polish patients with type 2 diabetes sub-optimally 
      controlled with metformin plus a sulfonylurea, participating in a 26-week 
      randomised, controlled open-label trial. MATERIAL AND METHODS: In Poland, 80 
      patients (HbA1c 7-10%, BMI 25-45 kg/m(2)) were randomised to exenatide 10 mug BID 
      (n = 40) or insulin glargine once daily (n = 40). We present exploratory analyses 
      on HbA1c, glucose profiles, body weight, hypoglycaemia and adverse events (AEs). 
      RESULTS: Mean (SD) baseline HbA1c was 7.9% (0.86) for exenatide and 7.8% (1.02) 
      for insulin glargine. At Week 26, LS mean (SEM) HbA1c decreased in both groups 
      (exenatide -0.72% [0.12]; glargine -0.64% [0.12]), as did fasting glucose. 
      Postprandial glucose excursions after breakfast and dinner were smaller in 
      patients treated with exenatide. LS mean (SEM) body weight decreased by -1.9 
      (0.48) kg with exenatide and increased by 1.6 (0.48) kg with glargine (group 
      difference [95%CI]: -3.5 kg [-4.9 to -2.2]). Hypoglycaemia was low in both 
      groups; nocturnal hypoglycaemia was reported for three v. seven patients (three 
      v. 24 episodes) in the exenatide and glargine groups, respectively. Adverse 
      events were more common with exenatide (nausea n = 22 v. n = 1, vomiting n = 5 v. 
      n = 0, headache n = 8 v. n = 2). CONCLUSION: This exploratory analysis confirms 
      that findings from the global study apply to patients treated with exenatide BID 
      and glargine in Poland, showing that exenatide BID was as effective as insulin 
      glargine. Data suggested that changes in HbA1c were similar, with fasting glucose 
      changes greater in the glargine group and postprandial changes greater in the 
      exenatide BID group. Exenatide BID was associated with weight reduction, less 
      nocturnal hypoglycaemia, but more gastrointestinal events compared to glargine.
FAU - Matyjaszek-Matuszek, Beata
AU  - Matyjaszek-Matuszek B
AD  - bmm@2com.pl.
FAU - Lenart-Lipinska, Monika
AU  - Lenart-Lipinska M
FAU - Rogalska, Dorota
AU  - Rogalska D
FAU - Nowakowski, Andrzej
AU  - Nowakowski A
CN  - GWAA Polish Study Group
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Poland
TA  - Endokrynol Pol
JT  - Endokrynologia Polska
JID - 0370674
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin, Long-Acting)
RN  - 0 (Peptides)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (Venoms)
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 9100L32L2N (Metformin)
RN  - 9P1872D4OL (Exenatide)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/*drug therapy/metabolism
MH  - Drug Administration Schedule
MH  - Exenatide
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Headache/chemically induced
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Insulin Glargine
MH  - Insulin, Long-Acting/*administration & dosage
MH  - Male
MH  - Metformin/administration & dosage
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Peptides/*administration & dosage/adverse effects
MH  - Sulfonylurea Compounds
MH  - Venoms/*administration & dosage/adverse effects
MH  - Vomiting/chemically induced
FIR - Cypryk, K
IR  - Cypryk K
FIR - Kasperska-Czyzyk, T
IR  - Kasperska-Czyzyk T
FIR - Kozlowski, A
IR  - Kozlowski A
FIR - Janik, K
IR  - Janik K
FIR - Jarosz-Skokowska, E
IR  - Jarosz-Skokowska E
FIR - Markiewicz, K
IR  - Markiewicz K
FIR - Polaszewska-Muszynska, M
IR  - Polaszewska-Muszynska M
FIR - Semetkowska-Jurkiewicz, E
IR  - Semetkowska-Jurkiewicz E
FIR - Stankiewicz, A
IR  - Stankiewicz A
EDAT- 2013/11/05 06:00
MHDA- 2014/12/15 06:00
CRDT- 2013/11/05 06:00
PHST- 2013/11/04 00:00 [received]
PHST- 2013/11/04 00:00 [accepted]
PHST- 2013/11/05 06:00 [entrez]
PHST- 2013/11/05 06:00 [pubmed]
PHST- 2014/12/15 06:00 [medline]
AID - VM/OJS/J/36137 [pii]
AID - 10.5603/EP.2013.0021 [doi]
PST - ppublish
SO  - Endokrynol Pol. 2013;64(5):375-82. doi: 10.5603/EP.2013.0021.