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CompletedNCT01505673Updated Jan 16, 2018Results posted

Adding Liraglutide to High Dose Insulin: Breaking the Cycle

A Phase 4 interventional study of Liraglutide and Saline in Type 2 Diabetes Mellitus and Obesity, sponsored by Ildiko Lingvay. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-16.

Sponsored by Ildiko Lingvay · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Obesity

Keywords

  • Insulin
  • Glucagon-like peptide
  • Liraglutide
  • Beta-Cell
  • pancreatic steatosis
  • hepatic steatosis
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 71 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

This is the only study on the registry with Ildiko Lingvay as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
71 participants (actual)

Study arms

  • Active comparator
    Liraglutide

    Drug: Liraglutide

  • Placebo comparator
    Saline injection

    Drug: Saline

Interventions

  • DrugLiraglutide

    Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months

    Also known as: Victoza

  • DrugSaline

    Placebo injection of 1.8mg saline once daily for 6-months

06

What researchers measure

Primary outcomes

  1. Glycemic Control Measured by HbA1c

    HbA1c (%)

    Time frame: 6-months

Secondary outcomes

  1. Pancreatic and Hepatic Triglyceride Content

    Liver Triglyceride and Pancreatic Triglyceride

    Time frame: 6-months

  2. Weight

    Time frame: 6-months

  3. Beta-Cell Function

    Fasting Glucose as a Measure of Beta-Cell Function

    Time frame: 6-months

  4. Glucagon

    Measured during mixed meal challenge test.

    Time frame: 6-months

  5. 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

  6. 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

  7. Blood Pressure

    Time frame: 6-months

  8. Lipid Profile

    Time frame: 6-months

  9. Liver Function Blood Test

    Time frame: 6-months

  10. 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

  11. 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

  12. Beta-Cell Function

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

    Time frame: 6 months

  13. 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

  14. Beta-cell Function

    AUC c-peptide

    Time frame: 6 Months

  15. Ratio (AUC C-peptide/AUC Glucose)

    Time frame: 6 months

  16. AUC Glucose

    Time frame: 6 months

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

07

Results

Posted Dec 15, 2017

Participant flow

Participant flow — Overall Study
MilestoneLiraglutideSaline Injection
Started3536
Completed3234
Not completed32

Outcome measures

PrimaryGlycemic Control Measured by HbA1c

HbA1c (%)

Time frame:
6-months
Reported as:
Mean · Percent HbA1c
Glycemic Control Measured by HbA1c
Percent HbA1cLiraglutideSaline Injection
Glycemic Control Measured by HbA1c7.9 ± 1.18.9 ± 1.3
SecondaryPancreatic and Hepatic Triglyceride Content

Liver Triglyceride and Pancreatic Triglyceride

Time frame:
6-months
Reported as:
Mean · Percent Triglyceride
Pancreatic and Hepatic Triglyceride Content
Percent TriglycerideLiraglutideSaline Injection
Liver Triglyceride12.3 ± 5.812.2 ± 7.8
Pancreatic Triglyceride12.53 ± 8.1314.64 ± 9.25
SecondaryWeight
Time frame:
6-months
Reported as:
Mean · Kilograms
Weight
KilogramsLiraglutideSaline Injection
Weight114 ± 21117 ± 27
SecondaryBeta-Cell Function

Fasting Glucose as a Measure of Beta-Cell Function

Time frame:
6-months
Reported as:
Mean · mg/dL
Beta-Cell Function
mg/dLLiraglutideSaline Injection
Beta-Cell Function179 ± 75197 ± 98
SecondaryGlucagon

Measured during mixed meal challenge test.

Time frame:
6-months
Reported as:
Mean · pg/mL
Glucagon
pg/mLLiraglutideSaline Injection
Glucagon107.3 ± 44.593.8 ± 37.8
SecondaryTotal 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
Reported as:
Median · IU
Total Daily Insulin Dose
IULiraglutideSaline Injection
Total Daily Insulin Dose200 (163 to 275)218 (160 to 260)
SecondaryNumber 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
Reported as:
Mean · number/day
Number of Daily Injections
number/dayLiraglutideSaline Injection
Number of Daily Injections3.7 ± 1.43.8 ± 1.3
SecondaryBlood Pressure
Time frame:
6-months
Reported as:
Mean · mmHg
Blood Pressure
mmHgLiraglutideSaline Injection
Systolic134 ± 18135 ± 17
Diastolic80.5 ± 13.774.3 ± 9.7
SecondaryLipid Profile
Time frame:
6-months
Reported as:
Mean · mg/dL
Lipid Profile
mg/dLLiraglutideSaline Injection
Total cholesterol154 ± 41152 ± 42
LDL83.9 ± 37.276.3 ± 28.4
HDL36.6 ± 9.837.6 ± 9.9
SecondaryLiver Function Blood Test
Time frame:
6-months
Reported as:
Mean · U/L
Liver Function Blood Test
U/LLiraglutideSaline Injection
ALT25.8 ± 13.536.0 ± 43.7
AST26.4 ± 17.632.1 ± 30.0
SecondaryHypoglycemic 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
Reported as:
Median · events per month per patient
Hypoglycemic Events
events per month per patientLiraglutideSaline Injection
Hypoglycemic Events1.1 (0.7 to 1.7)0.7 (0.5 to 1.2)
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - General Health Perception
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - General Health Perception3.1 ± 0.93.6 ± 0.6
SecondaryBeta-Cell Function

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

Time frame:
6 months
Reported as:
Mean · microgram/L
Beta-Cell Function
microgram/LLiraglutideSaline Injection
Beta-Cell Function2.48 ± 1.181.75 ± 1.19
SecondaryMatsuda 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
Reported as:
Mean · index
Matsuda Index as a Measure of Beta Cell Function
indexLiraglutideSaline Injection
Matsuda Index as a Measure of Beta Cell Function2.88 (1.67 to 3.70)3.12 (1.78 to 9.70)
SecondaryBeta-cell Function

AUC c-peptide

Time frame:
6 Months
Reported as:
Mean · ug/(L/min)
Beta-cell Function
ug/(L/min)LiraglutideSaline Injection
Beta-cell Function1234.6 ± 588.6922.9 ± 470.5
SecondaryRatio (AUC C-peptide/AUC Glucose)
Time frame:
6 months
Reported as:
Mean · Ratio
Ratio (AUC C-peptide/AUC Glucose)
RatioLiraglutideSaline Injection
Ratio (AUC C-peptide/AUC Glucose)0.019 ± 0.0100.013 ± 0.008
SecondaryAUC Glucose
Time frame:
6 months
Reported as:
Mean · mg/(dL/min)
AUC Glucose
mg/(dL/min)LiraglutideSaline Injection
AUC Glucose71747 ± 2214179278 ± 29416
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Current Health Perception
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Current Health Perception2.1 ± 0.92.6 ± 1.0
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Treatment Satisfaction
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Treatment Satisfaction2.4 ± 0.82.7 ± 0.7
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Treatment Impact
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Treatment Impact2.3 ± 0.52.6 ± 0.7
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Social or Vocational Worry
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Social or Vocational Worry1.5 ± 0.71.0 ± 0.9
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Hypoglycemia Fear
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Hypoglycemia Fear1.9 ± 0.72.0 ± 0.8
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Glycemia Control Perception
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Glycemia Control Perception2.0 ± 1.02.9 ± 1.0
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Lifestyle Flexibility
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Lifestyle Flexibility2.2 ± 0.92.6 ± 0.7
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Social Stigma
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Social Stigma2.5 ± 1.12.4 ± 1.0
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment1.6 ± 1.02.3 ± 1.3
SecondaryQuality 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
Reported as:
Mean · score on a scale
Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment
score on a scaleLiraglutideSaline Injection
Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment1.0 ± 0.52.1 ± 1.3

Adverse events

Collected over 6 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liraglutide0/35 (0%)1/35 (2.9%)14/35 (40%)
Saline Injection0/36 (0%)6/36 (16.7%)14/36 (38.9%)
Most frequent serious events
Most frequent serious events
EventLiraglutideSaline Injection
Stent placementCardiac disorders0/352/36
Atrial fibrilationCardiac disorders1/350/36
COPD exacerbationRespiratory, thoracic and mediastinal disorders0/351/36
Acute cholecystitisGastrointestinal disorders0/351/36
CellulitisSkin and subcutaneous tissue disorders0/351/36
GastroenteritisGastrointestinal disorders0/351/36
Most frequent other events
Most frequent other events
EventLiraglutideSaline Injection
NauseaGastrointestinal disorders11/357/36
Decreased in apetiteGastrointestinal disorders6/354/36
HeadacheNervous system disorders3/355/36
DiarrheaGastrointestinal disorders4/353/36
CoughRespiratory, thoracic and mediastinal disorders1/353/36
VomitingGastrointestinal disorders2/351/36
Abdominal discomfortGastrointestinal disorders1/351/36
Increase of serum amylaseGastrointestinal disorders1/351/36
Shortness of breathRespiratory, thoracic and mediastinal disorders1/350/36
HoarsenessRespiratory, thoracic and mediastinal disorders0/351/36

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)LiraglutideSaline InjectionTotal
<=18 years000
Between 18 and 65 years353671
>=65 years000
Age, Continuous
Age, Continuous(years)LiraglutideSaline InjectionTotal
Mean52.8 ± 8.155.5 ± 6.654.2 ± 7.4
Sex: Female, Male
Sex: Female, Male(Participants)LiraglutideSaline InjectionTotal
Female232245
Male121426
Region of Enrollment
Region of Enrollment(Participants)LiraglutideSaline InjectionTotal
United States323466
08

Study locations

1 site
  • UT Southwestern
    Dallas, Texas 75390, United States
09

References and documents

Publications

  • Vanderheiden A, Harrison L, Warshauer J, Li X, Adams-Huet B, Lingvay I. Effect of Adding Liraglutide vs Placebo to a High-Dose lnsulin Regimen in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):939-47. doi: 10.1001/jamainternmed.2016.1540. PubMed 27273731 ↗
  • Vanderheiden A, Harrison LB, Warshauer JT, Adams-Huet B, Li X, Yuan Q, Hulsey K, Dimitrov I, Yokoo T, Jaster AW, Pinho DF, Pedrosa I, Lenkinski RE, Pop LM, Lingvay I. Mechanisms of Action of Liraglutide in Patients With Type 2 Diabetes Treated With High-Dose Insulin. J Clin Endocrinol Metab. 2016 Apr;101(4):1798-806. doi: 10.1210/jc.2015-3906. Epub 2016 Feb 24. PubMed 26909799 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01505673
Lead sponsor
Ildiko Lingvay
Collaborators
Novo Nordisk A/S
Responsible party
Ildiko Lingvay (Assistant Professor, University of Texas Southwestern Medical Center) — Sponsor-investigator
First posted
Jan 6, 2012
Start date
Jan 2012
Primary completion
Jun 2016
Completion
Jun 2016
Results posted
Dec 15, 2017
Last update
Jan 16, 2018

Study contacts

Ildiko Lingvay, MD
principal investigator · UT Southwestern

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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