ID

20029

Description

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Keywords

  1. 12/19/16 12/19/16 -
  2. 2/4/17 2/4/17 -
Uploaded on

February 4, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Visit 7 / Early Termination ADDQoL [QS_2] NCT01117584

Visit 7 / Early Termination ADDQoL [QS_2] NCT01117584

General Information
Description

General Information

Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C2985720
In general, my Present quality of life is:
Description

Present quality of life

Data type

text

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C1948052
If I did not have diabetes, my quality of life woud be:
Description

Quality of life without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
If I did not have diabetes, I would enjoy my leisure activities:
Description

Leisure activites wihtout diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0023292
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My leisure activities are
Description

Leisure activities

Data type

text

Alias
UMLS CUI [1]
C0023292
Are you currently working, looking for work or would you like to work?
Description

Work

Data type

boolean

Alias
UMLS CUI [1]
C0043227
If I did not have diabetes, my work life would be:
Description

Work life without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0871202
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
For me, having a working life is:
Description

Importance of work life

Data type

text

Alias
UMLS CUI [1,1]
C0043227
UMLS CUI [1,2]
C3898777
If I did not have diabetes, local or long distance journeys would be:
Description

Long distance journeys without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
For me, long distance journeys are:
Description

Long distance journeys with diabetes

Data type

text

Alias
UMLS CUI [1]
C0040802
Did you ever go on holiday or want to go on holiday?
Description

Holidays

Data type

boolean

Alias
UMLS CUI [1]
C0019843
If I did not have diabetes, my holidays would be:
Description

Holidays without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0019843
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
For me, holidays are:
Description

Holidays with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0019843
UMLS CUI [1,2]
C0011849
If I did not have diabetes, physically I could do:
Description

Physical condition without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
For me, how much I can do physically is:
Description

Physical condition with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C3714565
UMLS CUI [1,2]
C0011849
Do you have any family/relatives?
Description

Family

Data type

boolean

Alias
UMLS CUI [1]
C0015576
If I did not have diabetes, my family life would be:
Description

Family without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0015576
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My family life is
Description

Family with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0015576
UMLS CUI [1,2]
C0011849
If I did not have diabetes, my friendships and social life would be:
Description

Friendships and social life without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0815198
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My friendships and social life are:
Description

Friendships and social life with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0815198
UMLS CUI [1,2]
C0011849
Do you have a close personal relationship (e.g husband/wife, partner)?
Description

Close personal relationship

Data type

boolean

Alias
UMLS CUI [1]
C1552027
If I did not have diabetes, my closest personal relationship would be:
Description

Close personal relationship without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C1552027
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
For me, having a close personal relationship is:
Description

Close personal relationship with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C1552027
UMLS CUI [1,2]
C0011849
Do you or would you like to have a sex life?
Description

Sex life

Data type

boolean

Alias
UMLS CUI [1]
C0009253
If I did not have diabetes, my sex life would be
Description

Sex life without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0009253
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
For me, having sex is:
Description

Sex life with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0009253
UMLS CUI [1,2]
C0011849
If I did not have diabetes, my physical appearance would be:
Description

Physical appearance without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0233426
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My physical appearance is:
Description

Physical appearance with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0233426
UMLS CUI [1,2]
C0011849
If I did not have diabetes, my self-confidence would be:
Description

Self-confidence without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0237529
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My self-confidence is:
Description

Self-confidence with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0237529
UMLS CUI [1,2]
C0011849
If I did not have diabetes, my motivation would be:
Description

Motivation without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0026605
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My motivation is:
Description

Motivation with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0026605
UMLS CUI [1,2]
C0011849
If I did not have diabetes, my future would be
Description

Feelings about the future without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0016884
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My feelings about the future are:
Description

Feelings about the future with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0016884
UMLS CUI [1,2]
C0011849
If I did not have diabetes, my financial situation would be
Description

Financial situation without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0376243
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My financial situation is:
Description

Financial situation with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0376243
UMLS CUI [1,2]
C0011849
If I did not have diabetes, my living conditions would be
Description

Living conditions without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0337645
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My living conditions are:
Description

Living conditions with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0337645
UMLS CUI [1,2]
C0011849
If I did not have diabetes, I would have to depend on others when I do not want to:
Description

Depending on others

Data type

text

Alias
UMLS CUI [1,1]
C0851827
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0011849
For me, not having to depend on others is:
Description

Not depending on others

Data type

text

Alias
UMLS CUI [1]
C0085862
If I did not have diabetes, my freedom to eat as I wish would be:
Description

Freedom to eat without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0013470
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My freedom to eat as I wish is:
Description

Freedom to eat with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0013470
UMLS CUI [1,2]
C0011849
If I did not have diabetes, my freedom to drink as I wish (e.g. fruit juice) would be:
Description

Freedom to drink without diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0452428
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0011849
My freedom to drink as I wish is:
Description

Freedom to drink with diabetes

Data type

text

Alias
UMLS CUI [1,1]
C0452428
UMLS CUI [1,2]
C0011849
Any other ways in which diabetes and its management and any complications affect your quality of life:
Description

Affect on quality of life

Data type

text

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C0011849

Similar models

Visit 7 / Early Termination ADDQoL [QS_2] NCT01117584

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
Assessment Date
Item
Assessment Date
date
C0034380 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
In general, my Present quality of life is:
text
C0034380 (UMLS CUI [1,1])
C1948052 (UMLS CUI [1,2])
Code List
In general, my Present quality of life is:
CL Item
excellent (1)
CL Item
very good (2)
CL Item
good (3)
CL Item
neither good nor bad  (4)
CL Item
bad (5)
CL Item
very bad (6)
CL Item
extremely bad (7)
Item
If I did not have diabetes, my quality of life woud be:
text
C0034380 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my quality of life woud be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
If I did not have diabetes, I would enjoy my leisure activities:
text
C0023292 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, I would enjoy my leisure activities:
CL Item
very much more  (1)
CL Item
much more (2)
CL Item
a little more  (3)
CL Item
the same  (4)
CL Item
less (5)
Item
My leisure activities are
text
C0023292 (UMLS CUI [1])
Code List
My leisure activities are
CL Item
very important  (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Work
Item
Are you currently working, looking for work or would you like to work?
boolean
C0043227 (UMLS CUI [1])
Item
If I did not have diabetes, my work life would be:
text
C0871202 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my work life would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
For me, having a working life is:
text
C0043227 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
Code List
For me, having a working life is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, local or long distance journeys would be:
text
C0040802 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, local or long distance journeys would be:
CL Item
very much easier (1)
CL Item
much easier (2)
CL Item
a little easier (3)
CL Item
the same (4)
CL Item
more difficult (5)
Item
For me, long distance journeys are:
text
C0040802 (UMLS CUI [1])
Code List
For me, long distance journeys are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Holidays
Item
Did you ever go on holiday or want to go on holiday?
boolean
C0019843 (UMLS CUI [1])
Item
If I did not have diabetes, my holidays would be:
text
C0019843 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my holidays would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
For me, holidays are:
text
C0019843 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
For me, holidays are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, physically I could do:
text
C3714565 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, physically I could do:
CL Item
very much more (1)
CL Item
much more (2)
CL Item
a little more (3)
CL Item
the same (4)
CL Item
less (5)
Item
For me, how much I can do physically is:
text
C3714565 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
For me, how much I can do physically is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important  (3)
CL Item
not at all important (4)
Family
Item
Do you have any family/relatives?
boolean
C0015576 (UMLS CUI [1])
Item
If I did not have diabetes, my family life would be:
text
C0015576 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my family life would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My family life is
text
C0015576 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My family life is
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my friendships and social life would be:
text
C0815198 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my friendships and social life would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My friendships and social life are:
text
C0815198 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My friendships and social life are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Close personal relationship
Item
Do you have a close personal relationship (e.g husband/wife, partner)?
boolean
C1552027 (UMLS CUI [1])
Item
If I did not have diabetes, my closest personal relationship would be:
text
C1552027 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my closest personal relationship would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
For me, having a close personal relationship is:
text
C1552027 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
For me, having a close personal relationship is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Sex life
Item
Do you or would you like to have a sex life?
boolean
C0009253 (UMLS CUI [1])
Item
If I did not have diabetes, my sex life would be
text
C0009253 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my sex life would be
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
For me, having sex is:
text
C0009253 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
For me, having sex is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my physical appearance would be:
text
C0233426 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my physical appearance would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My physical appearance is:
text
C0233426 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My physical appearance is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my self-confidence would be:
text
C0237529 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my self-confidence would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My self-confidence is:
text
C0237529 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My self-confidence is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my motivation would be:
text
C0026605 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my motivation would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My motivation is:
text
C0026605 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My motivation is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my future would be
text
C0016884 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my future would be
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My feelings about the future are:
text
C0016884 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My feelings about the future are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important  (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my financial situation would be
text
C0376243 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my financial situation would be
CL Item
very much bettter (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My financial situation is:
text
C0376243 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My financial situation is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my living conditions would be
text
C0337645 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my living conditions would be
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My living conditions are:
text
C0337645 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My living conditions are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, I would have to depend on others when I do not want to:
text
C0851827 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0011849 (UMLS CUI [1,4])
Code List
If I did not have diabetes, I would have to depend on others when I do not want to:
CL Item
very much less (1)
CL Item
much less (2)
CL Item
a little less (3)
CL Item
the same (4)
CL Item
more (5)
Item
For me, not having to depend on others is:
text
C0085862 (UMLS CUI [1])
Code List
For me, not having to depend on others is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my freedom to eat as I wish would be:
text
C0013470 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my freedom to eat as I wish would be:
CL Item
very much greater (1)
CL Item
much greater (2)
CL Item
a little greater (3)
CL Item
the same (4)
CL Item
less (5)
Item
My freedom to eat as I wish is:
text
C0013470 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My freedom to eat as I wish is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my freedom to drink as I wish (e.g. fruit juice) would be:
text
C0452428 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Code List
If I did not have diabetes, my freedom to drink as I wish (e.g. fruit juice) would be:
CL Item
very much greater (1)
CL Item
much greater (2)
CL Item
a little greater (3)
CL Item
the same (4)
CL Item
less (5)
Item
My freedom to drink as I wish is:
text
C0452428 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Code List
My freedom to drink as I wish is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Affect on quality of life
Item
Any other ways in which diabetes and its management and any complications affect your quality of life:
text
C0034380 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])

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