ID

20030

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

Versions (3)
  1. 12/19/16 12/19/16 -
  2. 2/4/17 2/4/17 -
  3. 9/20/21 9/20/21 -
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 Diab-MedSat [QS_3] NCT01117584

English

Visit 7 / Early Termination Diab-MedSat [QS_3] NCT01117584

1 forms  
General Information
Description

General Information

Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
1. Over the past two weeks, how bothered have you been by...
Description

1. Over the past two weeks, how bothered have you been by...

a. ...the amount of home monitoring (blood sugar testing) required as a part of using your medication(s)?
Description

Home monitoring

Data type

text

Alias
UMLS CUI [1]
C0005803
b. ... the number of times you need to take your medication(s)?
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
c. ...the need to adjust the dosing (amount) of your medication(s)?
Description

Adjustment of medication

Data type

text

Alias
UMLS CUI [1]
C1735490
d. ...how your medication(s) interferes with with your daily life?
Description

Interference of medication with daily life

Data type

text

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0001288
2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?
Description

2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?

a. Unwanted weight gain
Description

Unwanted weight gain

Data type

text

Alias
UMLS CUI [1]
C0043094
b. Pain or discomfort
Description

Pain or discomfort

Data type

text

Alias
UMLS CUI [1]
C0030193
UMLS CUI [2]
C0231218
c. Gas or bloating
Description

Gas or bloating

Data type

text

Alias
UMLS CUI [1]
C1291077
d. Diarrhea
Description

Diarrhea

Data type

text

Alias
UMLS CUI [1]
C0011991
e. Symptoms of low blood sugar (such as trembling, sweating, dizziness or blurred vision)
Description

Symptoms of low blood sugar

Data type

text

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C1457887
3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to....
Description

3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to....

a. ...keep your blood sugar levels stable (avoid highs and lows)?
Description

Blood sugar levels

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0085732
UMLS CUI [1,4]
C0242428
UMLS CUI [1,5]
C0005802
UMLS CUI [1,6]
C0205360
b. ...help you from feeling tired and lacking energy?
Description

Help from feeling tired

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0085732
UMLS CUI [1,4]
C0242428
UMLS CUI [1,5]
C0557875
4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with....
Description

4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with....

a. ...the ease and convenience of your diabetes medication(s)?
Description

Ease of medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0242428
UMLS CUI [1,4]
C1331418
b. ...the impact of your diabetes medication(s) on your physical well-being?
Description

Impact Medication Physical Well-Being

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C4049986
UMLS CUI [1,4]
C0517226
c. ...the impact of your diabetes medication(s) on your emotional well-being?
Description

Impact Medication Emotional Well-Being

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C4049986
UMLS CUI [1,4]
C0424578
5. Thinking about your diabetes medication(s) over the past two weeks....
Description

5. Thinking about your diabetes medication(s) over the past two weeks....

a. ...how difficult has it been for you to plan your daily activities around your medication(s)?
Description

Difficult to plan daily activities

Data type

text

Alias
UMLS CUI [1,1]
C0441655
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0332218
b. ...how much of a burden has it been for you to take your medication(s) as prescribed?
Description

Burden to take medication

Data type

text

Alias
UMLS CUI [1,1]
C2828008
UMLS CUI [1,2]
C1515187
UMLS CUI [1,3]
C0013227
c. ...how embarrased or awkward have you felt because of taking your medication(s)?
Description

Embarrassed to take medication

Data type

text

Alias
UMLS CUI [1,1]
C0557910
UMLS CUI [1,2]
C1515187
UMLS CUI [1,3]
C0013227
d. ...how worried have you been that your medication(s) is not helping you to slow down or prevent long-term complications?
Description

Worry Med Not Prevent Complication

Data type

text

Alias
UMLS CUI [1,1]
C0233481
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0199176
UMLS CUI [1,4]
C0009566
6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to...
Description

6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to...

a. ...be flexible with planning meals (when you eat and what you are able to eat)?
Description

Medication interferes with meals

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1998602
b. ...do your recommended physical activity or exercise?
Description

Medication Interferes with Exercise

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0026606
UMLS CUI [1,4]
C0015259
c. ...follow your recommended diet?
Description

Medication Interferes with Diet

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0012155
7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ....
Description

7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ....

...your current diabetes medication(s)?
Description

Current diabetes medication(s)

Data type

text

Alias
UMLS CUI [1,1]
C0242428
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0011849
8. Overall, based on your current experiences with your diabetes medications...
Description

8. Overall, based on your current experiences with your diabetes medications...

..how interested would you be to change the type of medication(s) you take or the way you take it, if it was possible?
Description

Interest to change medication(s)

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0543488
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Similar models

Visit 7 / Early Termination Diab-MedSat [QS_3] NCT01117584

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Item Group
1. Over the past two weeks, how bothered have you been by...
Item
a. ...the amount of home monitoring (blood sugar testing) required as a part of using your medication(s)?
text
C0005803 (UMLS CUI [1])
Home monitoring
Code List
a. ...the amount of home monitoring (blood sugar testing) required as a part of using your medication(s)?
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
Item
b. ... the number of times you need to take your medication(s)?
text
C3476109 (UMLS CUI [1])
Frequency
Code List
b. ... the number of times you need to take your medication(s)?
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
Item
c. ...the need to adjust the dosing (amount) of your medication(s)?
text
C1735490 (UMLS CUI [1])
Adjustment of medication
Code List
c. ...the need to adjust the dosing (amount) of your medication(s)?
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
Item
d. ...how your medication(s) interferes with with your daily life?
text
C0013216 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])
Interference of medication with daily life
Code List
d. ...how your medication(s) interferes with with your daily life?
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
Item Group
2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?
Item
a. Unwanted weight gain
text
C0043094 (UMLS CUI [1])
Unwanted weight gain
Code List
a. Unwanted weight gain
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
Item
b. Pain or discomfort
text
C0030193 (UMLS CUI [1])
C0231218 (UMLS CUI [2])
Pain or discomfort
Code List
b. Pain or discomfort
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
Item
c. Gas or bloating
text
C1291077 (UMLS CUI [1])
Gas or bloating
Code List
c. Gas or bloating
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
Item
d. Diarrhea
text
C0011991 (UMLS CUI [1])
Diarrhea
Code List
d. Diarrhea
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
Item
e. Symptoms of low blood sugar (such as trembling, sweating, dizziness or blurred vision)
text
C0020615 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Symptoms of low blood sugar
Code List
e. Symptoms of low blood sugar (such as trembling, sweating, dizziness or blurred vision)
CL Item
Not at all bothered (1)
CL Item
Slightly bothered (2)
CL Item
Somewhat bothered (3)
CL Item
Very bothered (4)
CL Item
Extremely bothered (5)
CL Item
Did not have this side effect (6)
Item Group
3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to....
Item
a. ...keep your blood sugar levels stable (avoid highs and lows)?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C0005802 (UMLS CUI [1,5])
C0205360 (UMLS CUI [1,6])
Blood sugar levels
Code List
a. ...keep your blood sugar levels stable (avoid highs and lows)?
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item
b. ...help you from feeling tired and lacking energy?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0242428 (UMLS CUI [1,4])
C0557875 (UMLS CUI [1,5])
Help from feeling tired
Code List
b. ...help you from feeling tired and lacking energy?
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item Group
4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with....
Item
a. ...the ease and convenience of your diabetes medication(s)?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0242428 (UMLS CUI [1,3])
C1331418 (UMLS CUI [1,4])
Ease of medication
Code List
a. ...the ease and convenience of your diabetes medication(s)?
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item
b. ...the impact of your diabetes medication(s) on your physical well-being?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0517226 (UMLS CUI [1,4])
Impact Medication Physical Well-Being
Code List
b. ...the impact of your diabetes medication(s) on your physical well-being?
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item
c. ...the impact of your diabetes medication(s) on your emotional well-being?
text
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0424578 (UMLS CUI [1,4])
Impact Medication Emotional Well-Being
Code List
c. ...the impact of your diabetes medication(s) on your emotional well-being?
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item Group
5. Thinking about your diabetes medication(s) over the past two weeks....
Item
a. ...how difficult has it been for you to plan your daily activities around your medication(s)?
text
C0441655 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0332218 (UMLS CUI [1,3])
Difficult to plan daily activities
Code List
a. ...how difficult has it been for you to plan your daily activities around your medication(s)?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Somewhat (3)
CL Item
Very (4)
CL Item
Extremely (5)
Item
b. ...how much of a burden has it been for you to take your medication(s) as prescribed?
text
C2828008 (UMLS CUI [1,1])
C1515187 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Burden to take medication
Code List
b. ...how much of a burden has it been for you to take your medication(s) as prescribed?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Somewhat (3)
CL Item
Very (4)
CL Item
Extremely (5)
Item
c. ...how embarrased or awkward have you felt because of taking your medication(s)?
text
C0557910 (UMLS CUI [1,1])
C1515187 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Embarrassed to take medication
Code List
c. ...how embarrased or awkward have you felt because of taking your medication(s)?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Somewhat (3)
CL Item
Very (4)
CL Item
Extremely (5)
Item
d. ...how worried have you been that your medication(s) is not helping you to slow down or prevent long-term complications?
text
C0233481 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0199176 (UMLS CUI [1,3])
C0009566 (UMLS CUI [1,4])
Worry Med Not Prevent Complication
Code List
d. ...how worried have you been that your medication(s) is not helping you to slow down or prevent long-term complications?
CL Item
Not at all (1)
CL Item
Slightly (2)
CL Item
Somewhat (3)
CL Item
Very (4)
CL Item
Extremely (5)
Item Group
6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to...
Item
a. ...be flexible with planning meals (when you eat and what you are able to eat)?
text
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,3])
Medication interferes with meals
Code List
a. ...be flexible with planning meals (when you eat and what you are able to eat)?
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
All the time (5)
Item
b. ...do your recommended physical activity or exercise?
text
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
Medication Interferes with Exercise
Code List
b. ...do your recommended physical activity or exercise?
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
All the time (5)
Item
c. ...follow your recommended diet?
text
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0012155 (UMLS CUI [1,3])
Medication Interferes with Diet
Code List
c. ...follow your recommended diet?
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
All the time (5)
Item Group
7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ....
Item
...your current diabetes medication(s)?
text
C0242428 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Current diabetes medication(s)
Code List
...your current diabetes medication(s)?
CL Item
Extremely dissatisfied (1)
CL Item
Very dissatisfied (2)
CL Item
Slightly dissatisfied (3)
CL Item
Neither dissatisfied or satisfied (4)
CL Item
Slightly satisfied (5)
CL Item
Very satisfied (6)
CL Item
Extremely satisfied (7)
Item Group
8. Overall, based on your current experiences with your diabetes medications...
Item
..how interested would you be to change the type of medication(s) you take or the way you take it, if it was possible?
text
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0543488 (UMLS CUI [1,3])
Interest to change medication(s)
Code List
..how interested would you be to change the type of medication(s) you take or the way you take it, if it was possible?
CL Item
Not at all interested  (1)
CL Item
Slightly interested (2)
CL Item
Somewhat interested (3)
CL Item
Very interested (4)
CL Item
Extremely interested (5)
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