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Evidence Table 4

Quality assessment of efficacy trials of newer drugs for the treatment of diabetes mellitus

Aronne, 2007 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Poor
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/44
2. Allocation adequate?Method not described2. Run-in/Washout:Yes/No
3. Groups similar at baseline?NR3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:NR
5. Loss to follow -up, differential?Unable to determine
6. Outcome assessors masked?Unclear, reported as double blindComments: QA performed on 44 patients in DM2 subgroup, not for entire study population
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Unclear, reported as double blind
9. Intention-to-treat analysis?No
10. Postrandomization exclusions?Unable to determine
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Aschner, 2006 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:1807/NR/741
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/Yes
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Yes*Comments: *This information was not provided in the publication but was provided by the manufacturer
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?No
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Barnett, 2007 Trial type: active-controlDesign: Other, Open, CrossoverQuality rating: Fair-poor
Internal validity External validity
1. Randomization adequate?Yes1. Number Screened/Eligible/Enrolled:196/NR/141
2. Allocation adequate?Yes2. Run-in/Washout:No/No
3. Groups similar at baseline?No3. Exclusion criteria reported?No
4. Eligibility criteria specified?Yes4. Funding:Eli Lilly
5. Loss to follow-up, differential?No
6. Outcome assessors masked?No Comments:
7. Care provider masked?No
8. Patients masked?No
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Blonde, 2006 Trial type: Open label extensionDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/974
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:Amylin Pharmaceuticals, Eli Lilly
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Buse, 2004 Trial type: placebo-controlledDesign: RCT - Parallel group, Triple blind, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/377
2. Allocation adequate?Method not described2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Eli Lilly & Amylin Pharmaceuticals
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Unclear, reported as triple blind Comments:
7. Care provider masked?Unclear, reported as triple blind
8. Patients masked?Yes
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Buse, 2007 Trial type: Open label extensionDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/974
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:Amylin Pharmaceuticals, Eli Lilly
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Charbonnel, 2006 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:1464/NR/701
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?NoComments: *This information was not provided in the publication but was provided by the manufacturer
6. Outcome assessors masked?Yes*
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Davis, 2007 Trial type: active-controlDesign: RCT - Parallel group, Open, ParallelQuality rating: Fair-poor
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:99/51/51
2. Allocation adequate?Method not described2. Run-in/Washout:No/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Eli Lilly & Amylin
5. Loss to follow-up, differential?No
6. Outcome assessors masked?No Comments:
7. Care provider masked?No
8. Patients masked?No
9. Intention-to-treat analysis?No
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
DeFronzo, 2005 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, ParallelQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/336
2. Allocation adequate?Method not described2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Pharmaceutical (Amylin & Eli Lilly)
5. Loss to follow-up, differential?No
6. Outcome assessors masked?YesComments: ITT-LOCF used
7. Care provider masked?Yes
8. Patients masked?Yes
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Edelman, 2006 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/296
2. Allocation adequate?Method not described2. Run-in/Washout:No/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:NR; Amylin Pharmaceuticals?
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Unclear, reported as double blind
9. Intention-to-treat analysis?Unable to determine
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Goldstein, 2007 Trial type: placebo-controlledDesign: RCT - Parallel group, DB,Quality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:3544/1208/1091
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/Yes
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?NoComments: *This information was not provided in the publication but was provided by the manufacturer
6. Outcome assessors masked?Yes*
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/117
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Heine, 2005 Trial type: active-controlDesign: RCT - Parallel group, Open, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes1. Number Screened/Eligible/Enrolled:844/555/551
2. Allocation adequate?Yes2. Run-in/Washout:No/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Amylin & Eli Lilly
5. Loss to follow-up, differential?No
6. Outcome assessors masked?No (open label) Comments:
7. Care provider masked?No (open label)
8. Patients masked?No (open label)
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Hermansen, 2007 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, ParallelQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:1098/NR/441
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/Yes
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?NoComments: *This information was not provided in the publication but was provided by the manufacturer
6. Outcome assessors masked?Yes*
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Hollander, 2003 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/656
2. Allocation adequate?Method not described2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:NR
5. Loss to follow-up, differential?Unable to determine
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Yes
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Unable to determine
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/NR
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:NR
5. Loss to follow-up, differential? Comments:
6. Outcome assessors masked?
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Hollander, 2004 Trial type: Pooled analysisDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/NR
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:NR
5. Loss to follow-up, differential? Comments:
6. Outcome assessors masked?
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Karl, 2007 Trial type: Open-label cohortDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/NR
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:NR
5. Loss to follow-up, differential? Comments:
6. Outcome assessors masked?
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Kendall, 2005 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/733
2. Allocation adequate?Method not described2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Eli Lilly & Amylin Pharmaceuticals
5. Loss to follow -up, differential?Unable to determine
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Unclear, reported as double blind
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
King, 2006 Trial type: retrospective uncontrolDesign: Other, Open, NAQuality rating: Poor
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/200
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:NR
5. Loss to follow-up, differential? Comments:
6. Outcome assessors masked?
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Klonoff, 2008 Trial type: Pooled analysisDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/NR
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Maggs, 2003 Trial type: Pooled analysisDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/NR
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:Amylin Pharmaceuticals
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Nauck, 2007 Trial type: active-controlDesign: RCT - Parallel group, Open, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes1. Number Screened/Eligible/Enrolled:641/NR/505
2. Allocation adequate?Yes2. Run-in/Washout:No/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Eli Lilly & Amylin
5. Loss to follow-up, differential?Unable to determine
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:2141/NR/1172
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Yes*Comments: *This information was not provided in the publication but was provided by the manufacturer
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?No
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Nelson, 2007 Trial type: open label extensionDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:156/141/127
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:Amylin Pharmaceuticals, Eli Lilly
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Nonaka, 2007 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, ParallelQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:262/NR/152
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/Yes
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Banyu Pharmaceutical and Merck
5. Loss to follow-up, differential?Unable to determine
6. Outcome assessors masked?Yes*Comments: *This information was not provided in the publication but was provided by the manufacturer
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?No
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Ratner, 2002 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, ParallelQuality rating: Fair-Poor
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/538
2. Allocation adequate?Method not described2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:NR (but 6 of 8 authors are from Amylin Pharma)
5. Loss to follow -up, differential?No
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Unclear, reported as double blind
9. Intention-to-treat analysis?Unable to determine
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Ratner, 2004 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, ParallelQuality rating: Fair-poor
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/651
2. Allocation adequate?Method not described2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:NR
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Yes
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Ratner, 2005 Trial type: Pooled analysisDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/477
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:NR
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Ratner, 2006 Trial type: Open label extensionDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/183/150
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:Amylin Pharmaceuticals, Eli Lilly and Company
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Raz, 2006 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:1387/NR/521
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/Yes
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Yes*Comments: *This information was not provided in the publication but was provided by the manufacturer
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Unable to determine
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Raz, 2008 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes1. Number Screened/Eligible/Enrolled:544/NR/190
2. Allocation adequate?Method not described2. Run-in/Washout:Yes/Yes
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Unclear, reported as double blind
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceYes
ContaminationNo
Riddle, 2006 Trial type: Open label extensionDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/591/518
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:Amylin Pharmaceuticals, Eli Lilly
5. Loss to follow-up, differential?
6. Outcome assessors masked? Comments:
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Riddle, 2007 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/212
2. Allocation adequate?Method not described2. Run-in/Washout:No/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:NR
5. Loss to follow -up, differential?No
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Unclear, reported as double blind
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Rosenstock, 2006 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:928/458/353
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes*3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Yes*Comments: * This information was not provided in the publication but was provided by the manufacturer
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Scott, 2007 Trial type: active-controlDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes1. Number Screened/Eligible/Enrolled:2186/NR/743
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/Yes
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Yes*Comments: * This information was not found in the
7. Care provider masked?Yes*publication but was provided by the manufacturer
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Scott, 2008 Trial type: active-controlDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes*1. Number Screened/Eligible/Enrolled:486/NR/273
2. Allocation adequate?Yes*2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:Merck
5. Loss to follow-up, differential?NoComments: * This information was not found in the publication but was provided by the manufacturer.
6. Outcome assessors masked?Yes*
7. Care provider masked?Yes*
8. Patients masked?Yes*
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceYes
ContaminationNo
Whitehouse, 2002 Trial type: Open label extensionDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?1. Number Screened/Eligible/Enrolled:NR/NR/236
2. Allocation adequate?2. Run-in/Washout:No/No
3. Groups similar at baseline?3. Exclusion criteria reported?
4. Eligibility criteria specified?4. Funding:NR; Amylin Pharmaceuticals?
5. Loss to follow-up, differential? Comments:
6. Outcome assessors masked?
7. Care provider masked?
8. Patients masked?
9. Intention-to-treat analysis?
10. Postrandomization exclusions?
11. Reporting of Attrition
Crossover
Adherence
Contamination
Whitehouse, 2002 Trial type: Open label extensionDesign: NAQuality rating: NA
Internal validity External validity
1. Randomization adequate?Method not described1. Number Screened/Eligible/Enrolled:NR/NR/480
2. Allocation adequate?Method not described2. Run-in/Washout:No/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?Yes
4. Eligibility criteria specified?Yes4. Funding:NR; Amylin Pharmaceuticals?
5. Loss to follow -up, differential?Unable to determine
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Unclear, reported as double blind
9. Intention-to-treat analysis?No
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverNo
AdherenceNo
ContaminationNo
Zinman, 2007 Trial type: placebo-controlledDesign: RCT - Parallel group, DB, NRQuality rating: Fair
Internal validity External validity
1. Randomization adequate?Yes1. Number Screened/Eligible/Enrolled:435/250/233
2. Allocation adequate?Yes2. Run-in/Washout:Yes/No
3. Groups similar at baseline?Yes3. Exclusion criteria reported?No
4. Eligibility criteria specified?Yes4. Funding:Eli Lilly & Amylin
5. Loss to follow-up, differential?No
6. Outcome assessors masked?Unclear, reported as double blind Comments:
7. Care provider masked?Unclear, reported as double blind
8. Patients masked?Yes
9. Intention-to-treat analysis?Yes
10. Postrandomization exclusions?Yes
11. Reporting of AttritionYes
CrossoverYes
AdherenceNo
ContaminationNo

From: Evidence Tables

Cover of Drug Class Review: Newer Drugs for the Treatment of Diabetes Mellitus
Drug Class Review: Newer Drugs for the Treatment of Diabetes Mellitus: Final Report [Internet].
Norris SL, Lee NJ, Severance S, et al.
Portland (OR): Oregon Health & Science University; 2008 Aug.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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