治験レーダー

Glycemic Control Measured by HbA1c

HbA1c (%)

6-months

Pancreatic and Hepatic Triglyceride Content

Liver Triglyceride and Pancreatic Triglyceride

6-months

Weight

6-months

Beta-Cell Function

Fasting Glucose as a Measure of Beta-Cell Function

6-months

Glucagon

Measured during mixed meal challenge test.

6-months

Total Daily Insulin Dose

The 3 days average of the total daily dose of insulin used within 3 consecutive days prior office visit 6 month.

6-months

Number of Daily Injections

The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month.

6-months

Blood Pressure

6-months

Lipid Profile

6-months

Liver Function Blood Test

6-months

Hypoglycemic Events

Reported as hypoglycemic events per month by patient as any blood glucose \<70 mg/dl or symptoms of hypoglycemia with blood glucose \>70 mg/dl

6-months

Quality of Life Survey (QoL) - General Health Perception

General health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = excellent; 2 = very good; 3 = good; 4 = fair; 5 = poor.

6-months

Beta-Cell Function

Fasting C-peptide as a Measure of Beta-Cell Function

6 months

Matsuda Index as a Measure of Beta Cell Function

The Matsuda index is a measure of insulin sensitivity and has no minimum/maximum values. Index values are calculated as 500,000/square root of ((fasting glucose x fasting c-peptide x 333) x (mean 120 min post-meal glucose x mean 120 min post-meal c-peptide x 333)). Higher/lower values = better/worse insulin sensitivity.

6 months

Beta-cell Function

AUC c-peptide

6 Months

Ratio (AUC C-peptide/AUC Glucose)

6 months

AUC Glucose

6 months

Quality of Life Survey (QoL) - Current Health Perception

Current health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.

6 months

Quality of Life Survey (QoL) - Treatment Satisfaction

Quality of Life Survey (QoL) - treatment satisfactionTreatment satisfaction was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.

6 months

Quality of Life Survey (QoL) - Treatment Impact

Treatment impact was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.

6 months

Quality of Life Survey (QoL) - Social or Vocational Worry

Social or vocational worry was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.

6 months

Quality of Life Survey (QoL) - Hypoglycemia Fear

Hypoglycemia fear was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry.

6 months

Quality of Life Survey (QoL) - Glycemia Control Perception

Glycemia control perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled.

6 months

Quality of Life Survey (QoL) - Lifestyle Flexibility

Lifestyle flexibility was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.

6 months

Quality of Life Survey (QoL) - Social Stigma

Social stigma was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.

6 months

Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment

Satisfaction with insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.

6 months

Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment

Willingness to continue insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.

6 months