Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Insulin, Glucagon-like peptide, Liraglutide, Beta-Cell, pancreatic steatosis, hepatic steatosis
Brief summary
The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a high-dose insulin regimen (\>1.8 units/kg/day) in patients with uncontrolled (HbA1c \>7.5%) type 2 diabetes mellitus will improve blood sugar control. It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores the mechanism of blood sugar improvement by assessing weight and pancreatic hormone release, and assesses blood pressure, lipid profile, and liver function. Finally it will look at patient quality of life and safety.
Detailed description
Type 2 diabetes is a progressive disease with incessant beta-cell dysfunction that often ultimately requires insulin treatment. Patients requiring high insulin dosages represent a particular treatment challenge and often have uncontrolled glycemia despite progressive dose increases and are especially prone to insulin related lipotoxicity and weight gain. Glucagon-like peptide agonists (GLP-1) such as liraglutide have many actions that position them to break the vicious cycle in this population through the following mechanisms: (1) weight loss; (2) improved hepatic steatosis; (3) improved pancreatic steatosis; (4) decreased glucagon levels; (5) improved beta-cell function. The purpose of the study is to demonstrate that liraglutide is both effective and safe when added to a high dose insulin treatment regimen. Liraglutide will improve glycemic control, weight, metabolic parameters, as well as patient satisfaction, with minimal adverse events. The study also proposes to study the mechanisms through which such improvements might occur, especially beta-cell function, glucagon levels, and hepatic and pancreatic fat content.
Interventions
DRUGLiraglutide
Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
DRUGSaline
Placebo injection of 1.8mg saline once daily for 6-months
Sponsors
Novo Nordisk A/S
Ildiko Lingvay
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus * Insulin dose of \>1.8 units/kg/day (represents total daily insulin dose, regardless of formulation, regimen, number of daily shots) * HbA1c ≥ 7.5% and ≤ 11% * Age ≥ 18 * Stable comorbidities on stable treatment regimens * Stable dose of all oral hypoglycemics for ≥ 3 months prior to enrollment * Ability to provide informed consent before any trial-related activities
Exclusion criteria
* Type 1 diabetes mellitus * Any contraindication to the MRI procedure (metallic implants, severe claustrophobia, pregnancy, unable to lie still on a hard table for the duration of the procedure, weight above 400 lb - limit of the MRI table, magnet's inner circumference smaller than the largest body circumference) * History of any pancreatic disease as it might interfere with the pancreatic TG measurement (i.e. pancreatitis, tumors, cysts, type 1 diabetes, any pancreatic surgery) * End Stage Renal Disease on dialysis due to increased risk of hypoglycemia, and possible interference with accurate measurement of HbA1c * Incretin therapy (any GLP-1 agonist or DPP-IV inhibitor) * Unstable or decompensated comorbidities * Personal or family history of medullary thyroid carcinoma or MEN-2 syndrome * Severe gastroparesis * Pregnancy, breast feeding, intention to become pregnant, or not using adequate contraceptive measures * Organ transplant recipient or waiting list candidate * Steroid use (current or potential use during the trial) * Known/suspected allergy to trial medication, excipients, or related products * Contraindications to study medications, worded specifically as stated in the product's prescribing information * Non-English speaking volunteers since no interpreters are available and the safety of the volunteers could be jeopardized if adequate and reliable communication is not possible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control Measured by HbA1c | 6-months | HbA1c (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 6-months | — |
| Beta-Cell Function | 6-months | Fasting Glucose as a Measure of Beta-Cell Function |
| Glucagon | 6-months | Measured during mixed meal challenge test. |
| Total Daily Insulin Dose | 6-months | The 3 days average of the total daily dose of insulin used within 3 consecutive days prior office visit 6 month. |
| Number of Daily Injections | 6-months | The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month. |
| Blood Pressure | 6-months | — |
| Lipid Profile | 6-months | — |
| Liver Function Blood Test | 6-months | — |
| Hypoglycemic Events | 6-months | 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 |
| Quality of Life Survey (QoL) - General Health Perception | 6-months | 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. |
| Matsuda Index as a Measure of Beta Cell Function | 6 months | 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. |
| Beta-cell Function | 6 Months | AUC c-peptide |
| Pancreatic and Hepatic Triglyceride Content | 6-months | Liver Triglyceride and Pancreatic Triglyceride |
| AUC Glucose | 6 months | — |
| Quality of Life Survey (QoL) - Current Health Perception | 6 months | 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. |
| Quality of Life Survey (QoL) - Treatment Satisfaction | 6 months | 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. |
| Quality of Life Survey (QoL) - Treatment Impact | 6 months | 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. |
| Quality of Life Survey (QoL) - Social or Vocational Worry | 6 months | 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. |
| Quality of Life Survey (QoL) - Hypoglycemia Fear | 6 months | 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. |
| Quality of Life Survey (QoL) - Glycemia Control Perception | 6 months | 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. |
| Quality of Life Survey (QoL) - Lifestyle Flexibility | 6 months | 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. |
| Quality of Life Survey (QoL) - Social Stigma | 6 months | 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. |
| Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment | 6 months | 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. |
| Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment | 6 months | 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. |
| Ratio (AUC C-peptide/AUC Glucose) | 6 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liraglutide Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months | 35 |
| Saline Injection Saline: Placebo injection of 1.8mg saline once daily for 6-months | 36 |
| Total | 71 |
Baseline characteristics
| Characteristic | Saline Injection | Liraglutide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 35 Participants | 71 Participants |
| Age, Continuous | 55.5 years STANDARD_DEVIATION 6.6 | 52.8 years STANDARD_DEVIATION 8.1 | 54.2 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment United States | 34 Participants | 32 Participants | 66 Participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 36 |
| other Total, other adverse events | 14 / 35 | 14 / 36 |
| serious Total, serious adverse events | 1 / 35 | 6 / 36 |
Outcome results
Primary
Glycemic Control Measured by HbA1c
HbA1c (%)
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Glycemic Control Measured by HbA1c | 7.9 Percent HbA1c | Standard Deviation 1.1 |
| Saline Injection | Glycemic Control Measured by HbA1c | 8.9 Percent HbA1c | Standard Deviation 1.3 |
Secondary
AUC Glucose
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | AUC Glucose | 71747 mg/(dL/min) | Standard Deviation 22141 |
| Saline Injection | AUC Glucose | 79278 mg/(dL/min) | Standard Deviation 29416 |
Secondary
Beta-cell Function
AUC c-peptide
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Beta-cell Function | 1234.6 ug/(L/min) | Standard Deviation 588.6 |
| Saline Injection | Beta-cell Function | 922.9 ug/(L/min) | Standard Deviation 470.5 |
Secondary
Beta-Cell Function
Fasting C-peptide as a Measure of Beta-Cell Function
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Beta-Cell Function | 2.48 microgram/L | Standard Deviation 1.18 |
| Saline Injection | Beta-Cell Function | 1.75 microgram/L | Standard Deviation 1.19 |
Secondary
Beta-Cell Function
Fasting Glucose as a Measure of Beta-Cell Function
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Beta-Cell Function | 179 mg/dL | Standard Deviation 75 |
| Saline Injection | Beta-Cell Function | 197 mg/dL | Standard Deviation 98 |
Secondary
Blood Pressure
Time frame: 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide | Blood Pressure | Systolic | 134 mmHg | Standard Deviation 18 |
| Liraglutide | Blood Pressure | Diastolic | 80.5 mmHg | Standard Deviation 13.7 |
| Saline Injection | Blood Pressure | Systolic | 135 mmHg | Standard Deviation 17 |
| Saline Injection | Blood Pressure | Diastolic | 74.3 mmHg | Standard Deviation 9.7 |
Secondary
Glucagon
Measured during mixed meal challenge test.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Glucagon | 107.3 pg/mL | Standard Deviation 44.5 |
| Saline Injection | Glucagon | 93.8 pg/mL | Standard Deviation 37.8 |
Secondary
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
Time frame: 6-months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liraglutide | Hypoglycemic Events | 1.1 events per month per patient |
| Saline Injection | Hypoglycemic Events | 0.7 events per month per patient |
Secondary
Lipid Profile
Time frame: 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide | Lipid Profile | Total cholesterol | 154 mg/dL | Standard Deviation 41 |
| Liraglutide | Lipid Profile | LDL | 83.9 mg/dL | Standard Deviation 37.2 |
| Liraglutide | Lipid Profile | HDL | 36.6 mg/dL | Standard Deviation 9.8 |
| Saline Injection | Lipid Profile | Total cholesterol | 152 mg/dL | Standard Deviation 42 |
| Saline Injection | Lipid Profile | LDL | 76.3 mg/dL | Standard Deviation 28.4 |
| Saline Injection | Lipid Profile | HDL | 37.6 mg/dL | Standard Deviation 9.9 |
Secondary
Liver Function Blood Test
Time frame: 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide | Liver Function Blood Test | ALT | 25.8 U/L | Standard Deviation 13.5 |
| Liraglutide | Liver Function Blood Test | AST | 26.4 U/L | Standard Deviation 17.6 |
| Saline Injection | Liver Function Blood Test | ALT | 36.0 U/L | Standard Deviation 43.7 |
| Saline Injection | Liver Function Blood Test | AST | 32.1 U/L | Standard Deviation 30 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Liraglutide | Matsuda Index as a Measure of Beta Cell Function | 2.88 index |
| Saline Injection | Matsuda Index as a Measure of Beta Cell Function | 3.12 index |
Secondary
Number of Daily Injections
The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Number of Daily Injections | 3.7 number/day | Standard Deviation 1.4 |
| Saline Injection | Number of Daily Injections | 3.8 number/day | Standard Deviation 1.3 |
Secondary
Pancreatic and Hepatic Triglyceride Content
Liver Triglyceride and Pancreatic Triglyceride
Time frame: 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liraglutide | Pancreatic and Hepatic Triglyceride Content | Liver Triglyceride | 12.3 Percent Triglyceride | Standard Deviation 5.8 |
| Liraglutide | Pancreatic and Hepatic Triglyceride Content | Pancreatic Triglyceride | 12.53 Percent Triglyceride | Standard Deviation 8.13 |
| Saline Injection | Pancreatic and Hepatic Triglyceride Content | Liver Triglyceride | 12.2 Percent Triglyceride | Standard Deviation 7.8 |
| Saline Injection | Pancreatic and Hepatic Triglyceride Content | Pancreatic Triglyceride | 14.64 Percent Triglyceride | Standard Deviation 9.25 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Current Health Perception | 2.1 score on a scale | Standard Deviation 0.9 |
| Saline Injection | Quality of Life Survey (QoL) - Current Health Perception | 2.6 score on a scale | Standard Deviation 1 |
Secondary
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.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - General Health Perception | 3.1 score on a scale | Standard Deviation 0.9 |
| Saline Injection | Quality of Life Survey (QoL) - General Health Perception | 3.6 score on a scale | Standard Deviation 0.6 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Glycemia Control Perception | 2.0 score on a scale | Standard Deviation 1 |
| Saline Injection | Quality of Life Survey (QoL) - Glycemia Control Perception | 2.9 score on a scale | Standard Deviation 1 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Hypoglycemia Fear | 1.9 score on a scale | Standard Deviation 0.7 |
| Saline Injection | Quality of Life Survey (QoL) - Hypoglycemia Fear | 2.0 score on a scale | Standard Deviation 0.8 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Lifestyle Flexibility | 2.2 score on a scale | Standard Deviation 0.9 |
| Saline Injection | Quality of Life Survey (QoL) - Lifestyle Flexibility | 2.6 score on a scale | Standard Deviation 0.7 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment | 1.6 score on a scale | Standard Deviation 1 |
| Saline Injection | Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment | 2.3 score on a scale | Standard Deviation 1.3 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Social or Vocational Worry | 1.5 score on a scale | Standard Deviation 0.7 |
| Saline Injection | Quality of Life Survey (QoL) - Social or Vocational Worry | 1.0 score on a scale | Standard Deviation 0.9 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Social Stigma | 2.5 score on a scale | Standard Deviation 1.1 |
| Saline Injection | Quality of Life Survey (QoL) - Social Stigma | 2.4 score on a scale | Standard Deviation 1 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Treatment Impact | 2.3 score on a scale | Standard Deviation 0.5 |
| Saline Injection | Quality of Life Survey (QoL) - Treatment Impact | 2.6 score on a scale | Standard Deviation 0.7 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Treatment Satisfaction | 2.4 score on a scale | Standard Deviation 0.8 |
| Saline Injection | Quality of Life Survey (QoL) - Treatment Satisfaction | 2.7 score on a scale | Standard Deviation 0.7 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment | 1.0 score on a scale | Standard Deviation 0.5 |
| Saline Injection | Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment | 2.1 score on a scale | Standard Deviation 1.3 |
Secondary
Ratio (AUC C-peptide/AUC Glucose)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Ratio (AUC C-peptide/AUC Glucose) | 0.019 Ratio | Standard Deviation 0.01 |
| Saline Injection | Ratio (AUC C-peptide/AUC Glucose) | 0.013 Ratio | Standard Deviation 0.008 |
Secondary
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.
Time frame: 6-months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liraglutide | Total Daily Insulin Dose | 200 IU |
| Saline Injection | Total Daily Insulin Dose | 218 IU |
Secondary
Weight
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide | Weight | 114 Kilograms | Standard Deviation 21 |
| Saline Injection | Weight | 117 Kilograms | Standard Deviation 27 |