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insulin secretagogues - DPP-4 inhibitors in diabetes type 2 for all types of patients, clinical trials results

alogliptin versus placebo
EXAMINE, 2011
NCT00968708

versus
alogliptin versus placebo (add on MET)
Nauck, 2009
NCT00286442
alogliptin 12.5 and 25 mg once daily
versus
placebo
patients whose HbA(1c) levels were inadequately controlled on metformin alonedouble-blind
Follow-up duration: 26 weeks
linagliptin versus glimepiride
CAROLINA, 2012
NCT01243424
linagliptin
versus
glimepiride 1-4 mg QD
patients with type 2 diabetes at elevated cardiovascular risk receiving usual caredouble-blind
Follow-up duration: 2 years
USA
linagliptin versus glimepiride (add on MET)
Gallwitz, 2012
NCT00622284
linagliptin (5 mg once daily) add-on therapy to preferably > 1500 mg metformin
versus
glimepiride (1—4 mg) orally once daily add-on therapy to preferably > 1500 mg metformin
type 2 diabetes mellitus with insufficient glycaemic control with metformindouble-blind
Follow-up duration: 104 weeks
USA
linagliptin versus Metformin + sulfonylurea
Owens, 0
NCT00602472
linagliptin
versus
combination of metformin and an SU
type 2 diabetes mellitus with insufficient glycaemic control with metformin in combination with a sulphonylurea
Follow-up duration: 24 weeks
Argentina
linagliptin versus placebo
Del Prato, 0
NCT00621140
Linagliptin monotherapy
versus
placebo
Type 2 Diabetic Patients With Insufficient Glycemic Control double-blind
Follow-up duration: 24 weeks
Croatia
linagliptin versus placebo (add on MET)
Taskinen, 0
NCT00601250
linagliptin 5 mg once daily
versus
placebo add on MET
patients with inadequately controlled type 2 diabetes for whom metformin therapy is inappropriate due to intolerability or contraindication
linagliptin versus placebo (add on pioglitazone)
Gomis, 2011
NCT00641043
initial combination of 30 mg pioglitazone plus 5 mg linagliptin
versus
pioglitazone plus placebo
patients with inadequately controlled type 2 diabetes
Follow-up duration: 24 weeks
linagliptin versus placebo (add on SU)
Lewin, 2010
NCT00819091
linagliptin 5 mg
versus
placebo (add-on to sulphonylurea)
patients with type 2 diabetes and insufficient glycaemic control double-blind
Follow-up duration: 18 weeks
saxagliptin versus glipizide
saxagliptin,
saxagliptin
versus
titrated glipizide plus metformin
adult patients with type 2 diabetes and inadequate glycemic controldouble-blind
Follow-up duration: 52 weeks
saxagliptin versus placebo
SAVOR-TIMI 53, 2013
NCT01107886
Saxagliptin 5 mg or 2.5 mg once daily
versus
Placebo
Patients With Type 2 Diabetes
USA
saxagliptin versus placebo (add on current treatment)
saxgliptin, renal study,
saxagliptin
versus
placebo added to patients’ current diabetes treatment
patients with moderate to severe renal impairment or end-stage renal disease
Follow-up duration: 12 weeks
saxagliptin versus placebo (add on insulin)
CV181-057,
NCT00757588
Saxagliptin, 5 mg
versus
placebo (on top insulin)
Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin
saxagliptin versus placebo (add on MET)
CV181-066,
NCT00683657
Saxagliptin
versus
placebo
Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ¡Ý1500 mg/Day
CV181-080,
NCT00885378
2.5 mg Saxagliptin, Twice Daily
versus
placebo
Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone
DeFronzo, 2009
NCT00121667
saxagliptin (2.5, 5, or 10 mg once daily)
versus
placebo
Patients With Inadequately Controlled Type 2 Diabetes With Metformin Alone
Follow-up duration: 24 weeks
Jadzinsky, 2009
NCT00327015
saxagliptin
versus
placebo
treatment-naïve patients with type 2 diabetes (T2D) and inadequate glycaemic control
saxagliptin versus placebo (add on TZD)
Hollander,
NCT00295633
saxagliptin (2.5 or 5 mg)
versus
placebo
patients with type 2 diabetes and inadequate control on thiazolidinedione alone
saxagliptin versus placebo (monotherapy)
CV181-011,
NCT00121641
oral saxagliptin 2.5, 5, or 10 mg once daily
versus
placebo

Follow-up duration: 24 weeks
CV181-038,
NCT00316082
Saxagliptin monotherapy
versus
placebo
type 2 diabetic subjects who are not controlled with diet and exercise
CV181-041,
NCT00374907
Saxagliptin
versus
placebo
Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Rosenstock, 2008
NCT00950599
saxagliptin 2.5, 5, 10, 20 or 40 mg once daily
versus
placebo
drug-naive patients with T2DM and inadequate glycaemic control
Follow-up duration: 12 weeks
saxagliptin versus sitagliptin (add on MET)
saxagliptin vs sitagliptin,
saxagliptin 5 mg once daily add on metformin
versus
sitagliptin 100 mg onece daily add on metformin
adults with type 2 diabetes who did not attain adequate glycemic control on metformin therapy alone
Follow-up duration: 18 weeks
saxagliptin + glyburide versus glyburide uptitration
CV181-040,
NCT00313313
saxagliptin added to a submaximal sulphonylurea dose
versus
uptitration of sulphonylurea monotherapy
patients with type 2 diabetes and inadequate glycaemic control with sulphonylurea monotherapy
Follow-up duration: 24 weeks
saxagliptin plus metformin XR 1500mg versus metformin up to 2000mg
CV181-085,
NCT00918138
Saxagliptin in Combination With Metformin XR 1500 mg
versus
Up-titrated Metformin XR to 2000 mg
Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg
sitagliptin versus control (add on MET)
Reasner, 2011
NCT00482729)
sitagliptin/metformin 50/500 mg bid uptitrated over 4 weeks to achieve maximum doses of sitagliptin/metformin 50/1000 mg bid
versus
metformin monotherapy
drug-naive patients with type 2 diabetesNA
sitagliptin versus glimepiride (add on MET)
Arechavaleta, 2011
NCT00701090
sitagliptin 100 mg daily
versus
glimepiride (starting dose 1 mg/day and up-titrated, based upon patient's self-monitoring of blood glucose results, to a maximum dose of up to 6 mg/day)
patients with type 2 diabetes inadequately controlled on metformin monotherapydouble-blind
Follow-up duration: 30 weeks
sitagliptin versus metformin
Goldstein (sit vs met), 2007
sitagliptin 100 dailyily
versus
metformin 1000 mg or 2000 mg daily;imag
Goldstein (sit+met vs met), 2007
sitagliptin 50 mg daily plus metformin 1000 or 2000 mg dailyç$4
versus
metformin 1000 or 2000 mg daily
sitagliptin versus pioglitazone
Pérez-Monteverde, 2011
NCT00541450
sitagliptin100 mg qd
versus
pioglitazone 15 mg qd, up-titrated to 30 mg after 6 weeks
drug-naïve patients with type 2 diabetesdouble-blind
Follow-up duration: 12 weeks
sitagliptin versus placebo
Goldstein, 2007
NCT00103857
sitagliptin 100 mg daily
versus
placebo
Hanefeld, 2007
sitagliptin 25 mg or 50 mg or 100 mg dailyi
versus
placebo
sitagliptin versus placebo (add on insulin+/-MET)
Vilsbøll, 2010
NCT00395343
once-daily sitagliptin 100 mg
versus
placebo
patients with type 2 diabetes inadequately controlled on long-acting, intermediate-acting or premixed insulin double-blind
sitagliptin versus placebo (add on MET)
Charbonnel, 2006
NCT0086515
sitagliptin 100 mg daily (add-on to metformin therapy)j
versus
placebo (add-on tometformin therapy);
Nauck, 2007
NCT00094770
sitagliptin 100 mg daily (add-on to metformin therapy)j
versus
placebo (add-on to metformin therapy);
raz, 2008
NCT00337610
sitagliptin 100 mg once daily
versus
placebo
patients with type 2 diabetes
Scott** (sit vs pbo on top met), 2007
sitagliptin 100 mg daily (add-on to metformin therapy)j
versus
placebo (add-on to metformin therapy).
patients with type 2 diabetes who were inadequately on mET monotherapy
sitagliptin versus placebo (add on PIO)
Rosenstock , 2006
NCT00086502
sitagliptin 100 mg once daily
versus
placebo
patients with type 2 diabetes and inadequate glycemic control double-blind
Follow-up duration: 24 weeks
sitagliptin versus placebo (on top PIO)
Rosenstock (sit on top pio vs pbo), 2006
NCT00086502
sitagliptin 100 mg daily (add-on to pioglitazone therapy)sl˜ðõØ
versus
placebo (add-on to pioglitazone therapy);
sitagliptin versus placebo (on-top glimepiride+/- metformine)
Hermansen, 2007
sitagliptin 100 mg daily (add-on to ongoing stable doses of glimepiride, alone or in combination with metformin)ocumen
versus
placebo (add-on to ongoing stable doses of glimepiride, alone or in combination with metformin);
sitagliptin versus rosiglitazone (add on MET)
Rigby , 2010
sitagliptin phosphate, 100 mg daily
versus
rosiglitazone maleate, 4 mg daily
type 2 diabetes mellitus inadequately controlled by metformin monotherapyopen
Follow-up duration: 16 weeks
sitagliptin versus Sulphonylurea (on top MET)
Al Sifri, 2011
sitagliptin 100 mg qd
versus
prestudy sulphonylurea
Muslim patients with type 2 diabetes who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months open
sitagliptin 50mg bid monotherapy versus glipizide
Scott* (sit vs glipi), 2007
sitagliptin 50mg bid
versus
glipizide 5mg to 20 mg dailyitm
patients with type 2 diabetes who have inadequate glycaemic control on diet and exercisedouble-blind
Follow-up duration: 12 weeks
sitagliptin 50mg bid monotherapy versus placebo
Scott* (sit vs pbo), 2007
sitagliptin 50 mg b.i.d
versus
placebo
sitagliptin monotherapy versus metformin
Aschner, 2010
NCT00449930
once-daily sitagliptin 100 mg
versus
twice-daily metformin 1000 mg
treatment-naïve patients with type 2 diabetesdouble-blind
Follow-up duration: 24 weeks
sitagliptin monotherapy versus placebo
Aschner, 2006
NCT00087516
sitagliptin 100 or 200 mg dailym
versus
placebo
patients with type 2 diabetes
Follow-up duration: 24 weeks
Barzilai, 2011
NCT00305604
once-daily sitagliptin (100 or 50 mg, depending on renal function)
versus
placebo
elderly patients with type 2 diabetesdouble-blind
Follow-up duration: 24 weeks
US
Chan, 2008
sitagliptin
versus
placebo
patients with type 2 diabetes and chronic renal insufficiencydouble-blind
Follow-up duration: 12 weeks
Mohan , 2009
sitagliptin 100mg once daily monotherapy
versus
placebo
Chinese, Indian, and Korean patients with type 2 diabetes inadequately controlled by diet and exercise.double-blind
Follow-up duration: 18 weeks
Nonaka, 2008
NCT00371007
sitagliptin 100 mg daily monotherapy
versus
placebo
Japanese patients with type 2 diabetesdouble-blind
Raz, 2006
sitagliptin 100 mg (or 200 mg) daily
versus
placebo
patients with type 2 diabetes mellitus and inadequate glycaemic control
sitagliptin monotherapy versus voglibose
Iwamoto , 2010
sitagliptin 50 mg once daily monotherapy
versus
voglibose 0.2 mg thrice daily before meals
Japanese patients with type 2 diabetesdouble-blind
Follow-up duration: 12 weeks
sitagliptin+pio versus metformin+pio
Derosa , 2010
pioglitazone 30 mg plus sitagliptin 100 mg once a day
versus
pioglitazone 15 mg plus metformin 850 mg twice a day
poorly controlled type 2 diabetes mellitus patients
vildagliptin versus gliclazide (add on MET)
Filozof, 2009
NCT00102466
vildagliptin (50 mg twice daily
versus
gliclazide (up to 320 mg/day
patients with Type 2 diabetes inadequately controlled with metformin double-blind
Follow-up duration: 52 weeks
vildagliptin versus glimepiride (add on MET)
Matthews , 2010
vildagliptin
versus
glimepiride
patients with type 2 diabetes mellitus inadequately controlled (HbA1c 6.5-8.5%) by metformin monotherapydouble-blind
Follow-up duration: 2 years
vildagliptin versus metformin
Goke, 2008
vildagliptin (100 mg daily)
versus
metformin (2 000 mg daily).
drug-naïve patients with type 2 diabetes
Schweizer, 2007
NCT00099866
vildagliptin 100mg
versus
metformin up to 2000 mg daily
drug-naïve patients with Type 2 diabetes
Follow-up duration: 52 weeks
Schweizer, 2009
NCT00246619
vildagliptin (100 mg daily
versus
metformin (titrated to 1500 mg daily
drug-naïve patients with type 2 diabetes aged>or=65 years
vildagliptin versus pioglitazone (add on MET)
Bolli, 2008
NCT00237237
vildagliptin 100 mg daily (add-on to metformin therapy)
versus
pioglitazone 30 mg daily (add-on to metformin therapy)j
patients with type 2 diabetes inadequately controlled with metformin monotherapydouble-blind
vildagliptin versus placebo
Mimori, 2006
vildagliptin 20 mg or 50 mg or 100 mg daily
versus
placebo
NCT00351832,
NCT00351832
vildagliptin 50mg qd, 50mg bid or 100mg qd
versus
placebo
Patients With Type 2 Diabetes
Follow-up duration: 12 weeks
Japan
Rosenstock, 2008
NCT00237250
vildagliptin (50 mg q.d.)
versus
placebo
subjects with impaired glucose tolerance double-blind
Follow-up duration: 12 weeks
Scherbaum [2], 2008
NCT00101712
vildagliptin 50 mg qd
versus
placebo
drug-naïve patients with type 2 diabetes and mild hyperglycaemiadouble-blind
Follow-up duration: 52 weeks
vildagliptin versus placebo (add on current therapy)
Lukashevich , 2011
NA
vildagliptin (50 mg qd)
versus
placebo
patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal impairment
Follow-up duration: 24 weeks
vildagliptin versus placebo (add on glimepiride)
Kikuchi, 2010
NCT00325117
vildagliptin 50mg twice-daily
versus
placebo
Japanese patients with Type 2 diabetes mellitusdouble-blind
Follow-up duration: 12 weeks
Japan
vildagliptin versus placebo (add on insulin)
Fonseca, 2007
NCT00099931
vildagliptin 100 mg daily (add-on to insulin therapy)y)
versus
placebo (add-on to insulin therapy)y)mag
type 2 diabetes that was inadequately controlled by insulindouble-blind
Follow-up duration: 24 weeks
Fonseca , 2008
vildagliptin added to insulin
versus
vildagliptin versus placebo (add on MET)
Ahren, 2004
vildagliptin 50 mg daily (add-on to metformin therapy)j
versus
placebo (add-on to metformin therapy)mag
patients with type 2 diabetes double-blind
Follow-up duration: 12 weeks
Bosi, 2007
NCT00099892
vildagliptin (50 or) 100 mg daily (add-on to metformin therapy)m
versus
placebo (add-on to metformin therapy)mag
patients with type 2 diabetes inadequately controlled with metformindouble-blind
Bosi, 2009
NCT00382096
vildagliptin plus high-dose metformin combination therapy (50 mg + 1000 mg twice daily),
versus
high-dose metformin monotherapy (1000 mg twice daily).
treatment-naive patients with type 2 diabetes mellitus
Follow-up duration: 24 weeks
Goodman, 2009
ildagliptin 100 mg given in the morning, vildagliptin 100 mg given in the evening
versus
placebo
patients inadequately controlled with metformindouble-blind
Follow-up duration: 24 weeks
NCT00396071,
NCT00396071
vildagliptin
versus
placebo
Patients With Type 2 Diabetes Treated With Metformin
NCT00494884 (Wollmer),
NCT00494884
Vildagliptin 100 mg o.d.
versus
placebo
Patients With Type 2 Diabetes Inadequately Controlled With Metformin
NCT00728351,
NCT00728351
Vildagliptin and Metformin (25/1000 mg Bid)
versus
Metformin Monotherapy (1000 mg Bid)
Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
NCT00822211,
NCT00822211
Vildagliptin 50 mg Bid or qd
versus
placebo
Chinese Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
Follow-up duration: 24 weeks
vildagliptin versus placebo (add on SU)
Garber, 2008
NCT00099944
vildagliptin (50 mg given once or twice daily)
versus
placebo
patients with type 2 diabetes inadequately controlled with a sulphonylureadouble-blind
Follow-up duration: 24 weeks
vildagliptin versus placebo (add on TZD)
Rosenstock** (vilda + pio vs pio), 2007
NCT00101803
vildagliptin 50 mg or 100 mg daily plus 15 mg or 30 mg pioglitazone dailyi
versus
pioglitazone 30 mg daily
drug-naive patients with type 2 diabetes double-blind
Follow-up duration: 24 weeks
vildagliptin versus placebo (on top pioglitazone)
Garber, 2007
NCT00099853
vildagliptin 50 or 100 mg daily (add-on to pioglitazone therapy)
versus
placebo (add-on to pioglitazone therapy)
vildagliptin versus rosiglitazone
Rosenstock, 2009
NCT00138619
vildagliptin (50 mg b.i.d
versus
rosiglitazone (8 mg q.d.,
drug-naïve type 2 diabetes mellitus patientsdouble-blind
Rosenstock* (vilda vs rosi), 2007
NCT00099918
vildagliptin 100 mg daily daily
versus
rosiglitazone 8 mg once daily
drug-naïve patients with type 2 diabetesdouble-blind
Follow-up duration: 24 weeks
vildagliptin versus Sulfonylurea (add on to MET)
Ferrannini, 2009
NCT00106340
vildagliptin 50 mg twice daily
versus
glimepiride titrated up to 6 mg/day
Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) double-blind
Follow-up duration: 52 weeks
vildagliptin versus TZD (add on MET)
GALIANT (Blonde), 2009
NCT00396227
vildagliptin 100 mg
versus
TZD (agent and dose at the investigators' discretion
patients inadequately controlled [haemoglobin A(1C) (HbA(1c)): 7-10%] on a stable dose of metformin (> or =1000 mg/day).
vildagliptin versus voglibose
Iwamoto, 2010
NA
vildagliptin (50 mg bid,
versus
voglibose (0.2 mg tid
Japanese patients with T2D who were inadequately controlled with diet and exercisedouble-blind
Follow-up duration: 12 weeks
Japan
NCT00368134,
NCT00368134
Vildagliptin 50 mg Bid
versus
Voglibose 0.2 mg Tid
patients with type 2 diabetes
Follow-up duration: 12 weeks
Japan
vildagliptin + MET versus MET
CLAF237A 23104,
NCT00396357

versus
vildagliptin monotherapy versus acarbose
Pan, 2008
NCT00110240
vildagliptin (100 mg daily, given as 50 mg twice daily
versus
acarbose (up to 300 mg daily, given as three equally divided doses
drug-naive patients with Type 2 diabetesdouble-blind
Follow-up duration: 24 weeks
vildagliptin monotherapy versus gliclazide
Foley, 2009
NCT00102388
monotherapy with vildagliptin 50 mg bid
versus
gliclazide up to 320 mg/day
drug-naïve patients with type 2 diabetesdouble-blind
Follow-up duration: 2 years
vildagliptin monotherapy versus pioglitazone
Rosenstock** (vilda vs pio), 2007
NCT00101803
vildagliptin 100 mg daily daily
versus
pioglitazone 30 mg dailyaily
drug-naive patients with type 2 diabetes double-blind
vildagliptin monotherapy versus placebo
Ahren, 2009
NCT00390520
vildagliptin (100 mg/d)
versus
placebo
drug-naive patients with type 2 diabetes
Dejager [1], 2007
NCT00099905
vildagliptin 50 mg or 100 mg daily
versus
placebo
drug-naïve patients with type 2 diabetesdouble-blind
Follow-up duration: 24 weeks
Foley, 2011
NCT00260156
vildagliptin 100 mg
versus
placebo
drug-naive patients with type 2 diabetes and mild hyperglycaemia
Kikuchi, 2009
vildagliptin 50mg bid
versus
placebo
Japanese patients with type 2 diabetes mellitus
Japan
Pi-Sunyer, 2007
NCT00120536
vildagliptin 50 mg or 100 mg daily, imag
versus
placebo
drug-naïve patients with type 2 diabetes double-blind
Follow-up duration: 24 weeks
Pratley, 2006
vildagliptin 25mg bid
versus
placebo
double-blind
Ristic, 2005
vildagliptin 25mg or 50mg or 100mg daily
versus
placebo

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