Adding Liraglutide to High Dose Insulin: Breaking the Cycle

• Sponsor: Ildiko Lingvay (Other)
• Overall Status: Completed
• CT.gov ID: NCT01505673
• Collaborator: Novo Nordisk A/S (Industry)
• Enrollment: 71
• Location: 1
• Arms: 2
• Duration (Months): 53
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus; Obesity	Drug: Liraglutide; Drug: Saline	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Adding Liraglutide to High Dose Insulin: Breaking the Cycle
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Liraglutide	Drug: Liraglutide; Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months; Other Names: Victoza
Placebo Comparator: Saline injection	Drug: Saline; Placebo injection of 1.8mg saline once daily for 6-months

Outcome Measures

Primary Outcome Measures

1. Glycemic Control Measured by HbA1c [6-months]

   HbA1c (%)

Secondary Outcome Measures

1. Pancreatic and Hepatic Triglyceride Content [6-months]

   Liver Triglyceride and Pancreatic Triglyceride

2. Weight [6-months]

3. Beta-Cell Function [6-months]

   Fasting Glucose as a Measure of Beta-Cell Function

4. Glucagon [6-months]

   Measured during mixed meal challenge test.

5. 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.

6. 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.

7. Blood Pressure [6-months]

8. Lipid Profile [6-months]

9. Liver Function Blood Test [6-months]

10. 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

11. 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.

12. Beta-Cell Function [6 months]

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

13. 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.

14. Beta-cell Function [6 Months]

    AUC c-peptide

15. Ratio (AUC C-peptide/AUC Glucose) [6 months]

16. AUC Glucose [6 months]

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern	Dallas	Texas	United States	75390

Sponsors and Collaborators

• Ildiko Lingvay
• Novo Nordisk A/S

Investigators

• Principal Investigator: Ildiko Lingvay, MD, UT Southwestern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ildiko Lingvay, Assistant Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01505673
• Other Study ID Numbers: IIS-000235
• First Posted: Jan 6, 2012
• Last Update Posted: Jan 16, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by Ildiko Lingvay, Assistant Professor, University of Texas Southwestern Medical Center: Insulin; Glucagon-like peptide; Liraglutide; Beta-Cell; pancreatic steatosis; hepatic steatosis
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Liraglutide

Study Results

Participant Flow

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Period Title: Overall Study
STARTED	35	36
COMPLETED	32	34
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Liraglutide	Saline Injection	Total
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months	Total of all reporting groups
Overall Participants	35	36	71
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	35 100%	36 100%	71 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.8 (8.1)	55.5 (6.6)	54.2 (7.4)
Sex: Female, Male (Count of Participants)
Female	23 65.7%	22 61.1%	45 63.4%
Male	12 34.3%	14 38.9%	26 36.6%
Region of Enrollment (Count of Participants)
United States	32 91.4%	34 94.4%	66 93%

Outcome Measures

1. Primary Outcome

Title	Glycemic Control Measured by HbA1c
Description	HbA1c (%)
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [Percent HbA1c]	7.9 (1.1)	8.9 (1.3)

2. Secondary Outcome

Title	Pancreatic and Hepatic Triglyceride Content
Description	Liver Triglyceride and Pancreatic Triglyceride
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Liver Triglyceride	12.3 (5.8)	12.2 (7.8)
Pancreatic Triglyceride	12.53 (8.13)	14.64 (9.25)

3. Secondary Outcome

Title	Weight
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [Kilograms]	114 (21)	117 (27)

4. Secondary Outcome

Title	Beta-Cell Function
Description	Fasting Glucose as a Measure of Beta-Cell Function
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [mg/dL]	179 (75)	197 (98)

5. Secondary Outcome

Title	Glucagon
Description	Measured during mixed meal challenge test.
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [pg/mL]	107.3 (44.5)	93.8 (37.8)

6. Secondary Outcome

Title	Total Daily Insulin Dose
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Median (Inter-Quartile Range) [IU]	200	218

7. Secondary Outcome

Title	Number of Daily Injections
Description	The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month.
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [number/day]	3.7 (1.4)	3.8 (1.3)

8. Secondary Outcome

Title	Blood Pressure
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Systolic	134 (18)	135 (17)
Diastolic	80.5 (13.7)	74.3 (9.7)

9. Secondary Outcome

Title	Lipid Profile
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Total cholesterol	154 (41)	152 (42)
LDL	83.9 (37.2)	76.3 (28.4)
HDL	36.6 (9.8)	37.6 (9.9)

10. Secondary Outcome

Title	Liver Function Blood Test
Time Frame	6-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
ALT	25.8 (13.5)	36.0 (43.7)
AST	26.4 (17.6)	32.1 (30.0)

11. Secondary Outcome

Title	Hypoglycemic Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Median (Inter-Quartile Range) [events per month per patient]	1.1	0.7

12. Secondary Outcome

Title	Quality of Life Survey (QoL) - General Health Perception
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	3.1 (0.9)	3.6 (0.6)

13. Secondary Outcome

Title	Beta-Cell Function
Description	Fasting C-peptide as a Measure of Beta-Cell Function
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [microgram/L]	2.48 (1.18)	1.75 (1.19)

14. Secondary Outcome

Title	Matsuda Index as a Measure of Beta Cell Function
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Inter-Quartile Range) [index]	2.88	3.12

15. Secondary Outcome

Title	Beta-cell Function
Description	AUC c-peptide
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [ug/(L/min)]	1234.6 (588.6)	922.9 (470.5)

16. Secondary Outcome

Title	Ratio (AUC C-peptide/AUC Glucose)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [Ratio]	0.019 (0.010)	0.013 (0.008)

17. Secondary Outcome

Title	AUC Glucose
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [mg/(dL/min)]	71747 (22141)	79278 (29416)

18. Secondary Outcome

Title	Quality of Life Survey (QoL) - Current Health Perception
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	2.1 (0.9)	2.6 (1.0)

19. Secondary Outcome

Title	Quality of Life Survey (QoL) - Treatment Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	2.4 (0.8)	2.7 (0.7)

20. Secondary Outcome

Title	Quality of Life Survey (QoL) - Treatment Impact
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	2.3 (0.5)	2.6 (0.7)

21. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	1.5 (0.7)	1.0 (0.9)

22. Secondary Outcome

Title	Quality of Life Survey (QoL) - Hypoglycemia Fear
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	1.9 (0.7)	2.0 (0.8)

23. Secondary Outcome

Title	Quality of Life Survey (QoL) - Glycemia Control Perception
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	2.0 (1.0)	2.9 (1.0)

24. Secondary Outcome

Title	Quality of Life Survey (QoL) - Lifestyle Flexibility
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	2.2 (0.9)	2.6 (0.7)

25. Secondary Outcome

Title	Quality of Life Survey (QoL) - Social Stigma
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	2.5 (1.1)	2.4 (1.0)

26. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	1.6 (1.0)	2.3 (1.3)

27. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Saline Injection
Arm/Group Description	Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months	Saline: Placebo injection of 1.8mg saline once daily for 6-months
Measure Participants	32	34
Mean (Standard Deviation) [score on a scale]	1.0 (0.5)	2.1 (1.3)

Adverse Events

Time Frame	6 months
Arm/Group Title	Liraglutide		Saline Injection
Arm/Group Description	Liraglutide: Liraglutide 1.8mg injected subcutaneously from pen device once daily for 6-months		Saline: Placebo injection of 1.8mg saline once daily for 6-months
All Cause Mortality
	Liraglutide		Saline Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/36 (0%)
Serious Adverse Events
	Liraglutide		Saline Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)		6/36 (16.7%)
Cardiac disorders
Atrial fibrilation	1/35 (2.9%)	1	0/36 (0%)	0
Stent placement	0/35 (0%)	0	2/36 (5.6%)	2
Gastrointestinal disorders
Acute cholecystitis	0/35 (0%)	0	1/36 (2.8%)	1
Gastroenteritis	0/35 (0%)	0	1/36 (2.8%)	1
Respiratory, thoracic and mediastinal disorders
COPD exacerbation	0/35 (0%)	0	1/36 (2.8%)	1
Skin and subcutaneous tissue disorders
Cellulitis	0/35 (0%)	0	1/36 (2.8%)	1
Other (Not Including Serious) Adverse Events
	Liraglutide		Saline Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/35 (40%)		14/36 (38.9%)
Gastrointestinal disorders
Nausea	11/35 (31.4%)	11	7/36 (19.4%)	7
Diarrhea	4/35 (11.4%)	4	3/36 (8.3%)	3
Vomiting	2/35 (5.7%)	2	1/36 (2.8%)	1
Decreased in apetite	6/35 (17.1%)	6	4/36 (11.1%)	4
Abdominal discomfort	1/35 (2.9%)	1	1/36 (2.8%)	1
Increase of serum amylase	1/35 (2.9%)	1	1/36 (2.8%)	1
Nervous system disorders
Headache	3/35 (8.6%)	3	5/36 (13.9%)	5
Respiratory, thoracic and mediastinal disorders
Cough	1/35 (2.9%)	1	3/36 (8.3%)	3
Hoarseness	0/35 (0%)	0	1/36 (2.8%)	1
Shortness of breath	1/35 (2.9%)	1	0/36 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.