Glimepiride Versus Metformin as
Mono
Type 2 Diabetes
A randomized, single-blind comparative study
erapy in Pediatric Patients With
Macnaet Gorracag, ot Aucxsanpaa Via, Mo? ‘ation (1). This increase may, in pat, be
Twouus Dawn, ot Jost Cana, wo ‘aunbeted to the dramac nse in ebild-
hood obesity (now es
mated at 15-20%
|— To compare the eileacy and cafety of glimeptede vers metformin n pel
ame subject with ype 2 chabetes inadequately controlled with det end exerese alone cr or
‘monorherapy,
ESEARCH DESIGN AND METHODS — This 26-weck, single-blind,
conolled, multinational study randomized 285 subjects to receive glimepitige (18 mag once
daly) or metformin (500-1000 mg twice daly) for 24 weeks. The primary end point was mean
change in ALC from baschine to week 24. Safety wes assesied by imaidence of hypoglycemia and
other adverse everts,
RESULTS — Sigifcart reductions from busine AIC were cen in both the glimepinde
(054%, P= 0.601} and metormin (=O 71%, P = 0.0002) groups. A total of 12% 36 of
132) and 48.198 (63 of 131) of subjects in he glimepiride and meormin groups, respectively,
in the iment-to-tre popultion achieved ALC <7 0% at week 24, No signifeantdiferences
‘were observed between groups in reductions in AI end self mentored blo glucose ves,
"Changes in serum pil concentrations, or ypogicem ieidencx Sigman ferences were
‘tbservediin mean chang ram baseline in BMI ictwen groups((.26 ky fon glimepiride and
0.33 kyo for metionnin, P= 0.003). The adjusted mean body weight increase vas 197 lig
for glimepicde and 0.55 kx for mecformin (P = 0.005). 4 hypoglycemic episode with blood
glucose <00 mach (<2.8 mmov) was experenced by 49 ona 4.2% of gimepinde and
retformin-reated subjects respectively, A single severe hypoglycemic event occurred in each
group.
CONCLUSIONS — Ctinepicide reduced AIC similarly to meiformin wich greater weight
sain, znd dhere was compatsble say over 24 weeks In the ueatment of pedis subjects wi
type 2 diabes12. Weeks 24 Wooks
Boo 8.5 Gassing)
BE 04 a4
ae -02 83
ra 82 5F
gs 04 oa 3B
og 08 30 38
Ea 06 79 =3
BE 07 x 73 8
SE os . + 1
2 09 win “oT te
205%
*P-< 0.08, change from baseline
Fignre 2—Adjuste mean change from baseline AAC n pediatric subjects with ype 2 dlabeies receiving ether glimepiride (m ® 132) or metformin
(a= 131). glimepiride; C, metformin
Wook 4 Week week 12 Weak 18 Wook 28
i
:
g:
Hs
EF 0) 20 am
| ic
: a MOK, a
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nan ans
igure 3—Agesed chong from baseline nosing MBG in pdr abject hte
PE Es aac a geet = 180) of efoto 8 wpe
iio