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Evidence Table 6Key Question 1: Quality assessment of trials for Key Question 1

Study Characteristics
Author, Year
Trial Name (if app.)
Duration
Country
Funding
Quality
Randomization adequate?
Yes, No, NR
Allocation concealment adequate?
Yes, No, NR
Groups similar at baseline?
Yes, No, NR
Outcome assessors masked?
Yes, No, NR
Care provider masked?
Yes, No, NR
Patient masked?
Yes, No, NR
Run-in/Washout?
Yes, No, NR
Overall attrition high (>20%)?
Yes, No, NR
Loss to follow-up differential high (>15%)?
Yes, No, NR
Outcome measures (ascertainment) equal, valid, and reliable?
Yes, No, Mixed
Intention-to-treat (ITT) analysis?
Yes, No, NR, Modified ITT
Post- randomization exclusions?
Yes, No, NR
Bergenstal, 2009
Novo-Log Mix vs Exenatide Study Group
24 weeks
United States
Novo Nordisk
Poor
YesYesYesNoNoNoNoYesNoYesNRYes
Brodows, 2008
Duration NR
Eli Lilly and Amylin Pharmaceuticals
Poor
NRNoYesNoNoNoNRYesNoYesNoYes
Buse, 2009
LEAD-6
26 weeks
Mulitnational Novo Nordisk
Fair
YesYesYesNoNoNoYesNoNoYesYesNo
Feinglos, 2005
12 weeks
US Novo Nordisk
Poor
NRNRYesNRNRYesYesNoYesYesNoYes
Gao, 2009
16 weeks
Multiple, Asia
Amylin Pharmaceuticals and Eli Lilly
Good
YesNRYesNRYesYesYesNoNoYesModified ITTYes
Garber, 2009
LEAD-3 MoNo
52 weeks
US and Mexico
Novo Nordisk
Fair
YesNRYesNRNRYesYesYesNoYesYesNR
Kadowaki, 2009
12 weeks
Japan
Amylin Pharmaceuticals and Eli Lilly
Fair
YesYesYesNRYesYesYesNoNoYesNoYes
Madsbad, 2004
12 weeks
Scandanavia and the UK
Novo Nordisk
Fair
NRNRYesNRNRYesYesNoYesYesModified ITTNo
Moretto, 2008
24 weeks
United States, Puerto Rico, Romania, Russia, and India
Amylin Pharamceuticals and Eli Lilly and Company
Good
YesYesYesNRYesYesYesNoNoYesModified ITTYes
Nauck, 2009
LEAD-2
26 weeks
Multinational
Novo Nordisk
Fair
YesNRYesNRNRYesYesNoYesYesModified ITTNo
Russel-Jones, 2009
LEAD-5
26 weeks
Multinational
Novo Nordisk
Good
YesYesYesYesYesYesYesNoNoYesYesNR
SeiNo, 2008
14 weeks
Japan
Novo Nordisk
Good
YesYesYesYesNRYesYesNoNoYesModified ITTNo
Vilsboll, 2007
14 weeks
Denmark, France, the Netherlands, Slovakia
Novo Nordisk
Fair
NRNRYesNRYesYesYesNoNoYesModified ITTYes
Vilsboll, 2008
14 weeks
Denmark, France, the Netherlands, Slovakia
Novo Nordisk
Poor
NRNRNoNRYesYesYesYesNoYesNoYes
Zinman, 2009
LEAD-4
26 weeks
US and Canada
Novo Nordisk
Fair
YesNRYesYesNRYesYesYesYesYesModified ITTYes
Riddle, 2009
24 weeks
US
Amylin Pharmaceuticals
Fair
YesYesYesNoNoNoNoNoNoYesModified ITTYes
Chacra, 2009
CV181-040
24 weeks
Multinational
Bristol-Myers Squibb and AstraZeneca
Fair
YesYesYesNRYesYesYesYesNoYesNoYes
Rosenstock, 2009
CV181-011 Study
24 weeks
US
Bristol-Myers Squibb and AstraZeneca
Fair
NRNRYesYesYesYesYesYesNoYesModified ITTYes
Rosenstock, 2008
12 weeks
Multinational
Bristol-Myers Squibb
Fair
NRNRYesNRYesYesYesNoNoYesModified ITTYes
DeFronzo, 2009
Saxagliptin CV181-014 Study
24 weeks
Multinational
Bristol-Myers Squibb & AstraZeneca
Fair
YesNRYesNRYesYesYesYesYesYesModified ITTYes
Hollander, 2009
CV181-013
24 weeks
US
Bristol-Meyers Squibb and AstraZeneca
Fair
YesYesYesNRYesYesYesYesNoYesModified ITTYes
Williams-Herman, 2009
54 weeks
Williams-Herman, 2010
104 weeks
Multinational
Merck
Fair
NRYesYesYesYesYesYesYesYesYesModified ITTNo
Chan, 2008
54 weeks
Multinational
Merck
Fair
YesNRYesYesYesYesYesYesNoYesModified ITTYes
Hanefeld, 2007
Sitagliptin Study 014
12 weeks
Multinational
Fair
YesNRYesYesYesYesYesNoYesYesModified ITTYes
Nonaka, 2008
12 weeks
Japan
Banyu Pharmaceuticals (Merck)
Good
NRYesNRYesYesYesNoNoYesModified ITTYes
Mohan, 2009
18 weeks
China, India, Korea
Merck
Good
YesYesYesYesYesYesYesNoYesModified ITTNo
Raz, 2008
30 weeks
Multinational
Merck
Fair
YesNoYesYesYesYesNoNoYesNoYes
Chogtu, 2009
12 weeks
India
Funding NR
Poor
YesYesNRNRNoNoNoNoNRYesNoYes
Berneis, 2008
12 weeks
Switzerland
Government funding
Poor
NRNRYesNRNRNRYesNoNoYesNRNo
Beysen, 2008
20 weeks
US
Funding NR
Fair
NRNRYesNoNoNoNoNoNoYesNRYes
Vijay, 2009
16 weeks
India
UGC, India
Fair
YesNRYesNRNRNRNoNRNRYesNRNR
Oz, 2008
12 weeks
Turkey
Funding NR
Fair
NRNRYesNRNRNRNoYesNoYesNRNo
OZ Gul, 2010
12 weeks
Turkey
Funding NR
Fair
NRNRYesNRNRNRNoYesNoYesNRNo
Erdem, 2008
12 weeks
Turkey
Gulthane School of Medicine
Poor
NRNRYesNRNRNRNoNoNoYesNRYes
Papathanassiou, 2009
6 months
Greece
Funding NR
Fair
YesNoYesNRNoNoNoNoNoYesNRNR
Tolman, 4039
Poor
YesYesYesYesYesYesNoYesNoYesModified ITTNo
Tsuchiya, 2009
Poor
NRNoYesNRNRNRNoNoNoYesNRNo
Van der Meer, 2009
PIRAMID
24 weeks
The Netherlands
Eli Lilly, Takeda
Good
YesYesYesYesYesYesYesNoNoYesNRNo
Schernthaner, 2004
Quarter Study
12 months
Multinational
Funding NR
Good
YesYesYesYesNRYesNoNoNoYesModified ITTYes
Kusaka, 2008
4 months
Japan
Funding NR
Fair
NRNRYesNoNoNoNoNoNoYesNoYes
Nissen, 2008
PERISCOPE
18 months
Multinational
Takeda Pharmaceuticals
Fair
YesYesYesYesYesYesNoYesNoYesNoYes
Marre, 2003
LEAD-1SU
26 weeks
Multinational
Novo Nordisk
Fair
NRNRYesNRNRYesYesNoNoYesYesYes
Bao, 2009
48 weeks
China
Government funding
Poor
NRNRNRNRNRNRYesNoNoYesNRNR
Pop-Busui, 2009
6 months
US
GlaxoSmithKline, Eli Lilly, Research Foundations
Fair
NRNRNoNRNRNRYesNoNoYesNRNR
Turkmen Kemal, 2007
Poor
NRNRYesNRNRNRNoNoNoYesNRNo
von Bibra, 2008
16 weeks (32-week cross-over)
Germany
Funding NR
Fair
NRNoYesYesNRNRYesNoNoYesNoYes
Iliadis, 2007
18 weeks
Greece
Funding NR
Poor
NRNRNoNRNRNRYesNoNoYesNoYes
Home, 2009
RECORD
7 year study, mean follow up time 5.5 years
Multinational
GlaxoSmithKline
Fair
YesYesYesNoNoNoNoNoNoYesModified ITTYes
Kiyici, 2009
12 months
Turkey
Funding NR
Fair
NRNRYesNoNoNoNoNoNoYesNRNo
Scott, 2008
18 weeks
Multinational
Merck
Fair
NRNRYesNRYesYesYesNoNoYesModified ITTYes
Hamann, 2008
52 weeks
Multinational
Funding NR
Fair
YesYesYesNRYesYesYesYesNoYesModified ITTYes
Nauck, 2009
LEAD-1/LEAD-2
26 weeks
Multinational
Funding NR
NRNRYesYesYesYesYesNRNRYesModified ITTNR
Derosa, 2009
The 60’s study
15 months
Italy
Funding NR
Fair
YesNRYesYesYesYesNoNoNRYesModified ITTNo
McCluskey, 2004
20 weeks
US
Funding NR
Fair
NoNRNoNRNRYesYesNoNoYesYesNo
Stewart, 2006
32 weeks
Multinational
GlaxoSmithKline
Fair
NRNRYesNRYesYesYesYesNoYesModified ITTYes
Weissman, 2005
EMPIRE
24 weeks
US
GlaxoSmithKline
Fair
NRNRNRNRYesYesYesYesNoYesModified ITTYes
Goldstein, 2006
EMPIRE
24 weeks
US
GlaxoSmithKline
Fair
NRNRNoNRYesYesYesNoNoYesYesYes
Seck, 2010
104 weeks
Multinational
Merck
Fair
Extension of Nauck, 2007 (from previous report)
YesYesYesYesNRYesYesYesNoYesNoNo
Aschner, 2010
24 weeks
Multinational
Merck
Fair
YesYesYesYesNRYesYesNoNoYesNoYes
Vilsboll, 2010
24 weeks
Multinational
Merck
Fair
NRNRYesYesNRYesYesNoNoYesModified ITTNo
Dersoa, 2010
52 weeks
Italy
University of Pavia
Fair
NRNRYesNRNRNRNoNoNoMixedNoYes
Gill, 2010
12 weeks
Multinational
Eli Lilly
Fair
NRNRYesNRNRNRYesNoNoYesYesNo
Pratley, 2010
26 weeks
Multinational
Novo Nordisk
Fair
YesYesYesYesNoNoNRNoNoYesYesYes
Apovian, 2010
24 weeks
US
Eli Lilly
Fair
YesYesYesNRNRNRNoYesNoYesModified ITTNo
Derosa, 2010
52 weeks
Italy
NR
Fair
YesYesYesNRNRNRNoNoNoYesNoYes
DeFronzo, 2010
20 weeks
US
Eli Lilly
Fair
NRNRYesNoNoNoNoYesNoMixedYesNo
Brackenridge, 2009
Poor
NRNRNoNRYesYesNoNRNRMixedNRNR
Kadoglou, 2010
14 weeks
Greece
European Social Fund and National Resources - PYTHAGORAS II & Alexander S Onassis Public Benefit Foundation
Fair
YesNRYesNoNoNoYesNoNoYesNoYes
Kato, 2009
12 weeks
Japan
Fair
NRYesYesNRNRNRYesNRNRYesNRNo
Perez, 2009
24 weeks
Multinational
Takeda
Pharmaceuticals
Fair
NRNRYesNRYesYesYesYesNoYesModified ITTNo
Petrica, 2009
Poor
NRNRYesYesNoNoNoYesNoMixedNoYes
Gerstein, 2010
18 months
Multinational
GlaxoSmithKline
Fair
YesNRYesYesYesYesYesYesNoYesNoNo
DeFronzo, 2010
20 weeks
USA
Eli Lilly
NRNRNRNoNoNoNoYesNoMixedYesNo
Rigby, 2010
16 weeks
Mulitnational
Daiichi Sankyo, Inc
Fair
NRNRYesNoNoNoYesNoNoYesModified ITTYes

From: Evidence Tables

Cover of Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations
Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations: Final Original Report [Internet].
Jonas D, Van Scoyoc E, Gerrald K, et al.
Portland (OR): Oregon Health & Science University; 2011 Feb.
Copyright © 2011, Oregon Health & Science University.

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