Type 2 Diabetes MellitusPhase 4NCT01505673
Adding Liraglutide to High Dose Insulin: Breaking the Cycle
A Phase 4 study testing Liraglutide and Saline in people with Type 2 Diabetes Mellitus and Obesity, run by Ildiko Lingvay at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- Liraglutide and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- Liraglutide, Saline
- Keywords
- Insulin, Glucagon-like peptide, Liraglutide, Beta-Cell, pancreatic steatosis, hepatic steatosis
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Insulin Resistance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
SalineDrug
Placebo injection of 1.8mg saline once daily for 6-months
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Active comparator | Not described Receives: Drug: Liraglutide |
| Saline injection | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control Measured by HbA1c
HbA1c (%)
Measured: 6-months
Secondary outcomes (26)
Pancreatic and Hepatic Triglyceride Content
Liver Triglyceride and Pancreatic Triglyceride
Measured: 6-months
Weight
Measured: 6-months
Beta-Cell Function
Fasting Glucose as a Measure of Beta-Cell Function
Measured: 6-months
Glucagon
Measured during mixed meal challenge test.
Measured: 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.
Measured: 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.
Measured: 6-months
Blood Pressure
Measured: 6-months
Lipid Profile
Measured: 6-months
Liver Function Blood Test
Measured: 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
Measured: 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.
Measured: 6-months
Beta-Cell Function
Fasting C-peptide as a Measure of Beta-Cell Function
Measured: 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.
Measured: 6 months
Beta-cell Function
AUC c-peptide
Measured: 6 Months
Ratio (AUC C-peptide/AUC Glucose)
Measured: 6 months
AUC Glucose
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ildiko Lingvay
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Ildiko Lingvay, University of Texas Southwestern Medical Center
- Investigators
- Ildiko Lingvay, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505673
- Sponsor's protocol ID
- IIS-000235
- Status last verified
- Dec 2017
- First submitted
- 4 Jan 2012
- Last updated
- 16 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 27273731Vanderheiden 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Liraglutide to High Dose Insulin: Breaking the Cycle
- ClinicalTrials.gov ID
- NCT01505673
- Acronym / sponsor ID
- IIS-000235
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Keywords
- Insulin, Glucagon-like peptide, Liraglutide, Beta-Cell, pancreatic steatosis, hepatic steatosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ildiko LingvayUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jan 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Posted 15 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Active comparator | Drug: Liraglutide |
| Saline injection | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: VictozaLiraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months | Drug | Liraglutide |
| SalinePlacebo injection of 1.8mg saline once daily for 6-months | Drug | Saline injection |
Primary outcome
Glycemic Control Measured by HbA1c
Time frame: 6-months
HbA1c (%)
26 secondary outcomes
Pancreatic and Hepatic Triglyceride Content
Time frame: 6-months
Weight
Time frame: 6-months
Beta-Cell Function
Time frame: 6-months
Glucagon
Time frame: 6-months
Total Daily Insulin Dose
Time frame: 6-months
Number of Daily Injections
Time frame: 6-months
Blood Pressure
Time frame: 6-months
Lipid Profile
Time frame: 6-months
Liver Function Blood Test
Time frame: 6-months
Hypoglycemic Events
Time frame: 6-months
Quality of Life Survey (QoL) - General Health Perception
Time frame: 6-months
Beta-Cell Function
Time frame: 6 months
Matsuda Index as a Measure of Beta Cell Function
Time frame: 6 months
Beta-cell Function
Time frame: 6 Months
Ratio (AUC C-peptide/AUC Glucose)
Time frame: 6 months
AUC Glucose
Time frame: 6 months
Quality of Life Survey (QoL) - Current Health Perception
Time frame: 6 months
Quality of Life Survey (QoL) - Treatment Satisfaction
Time frame: 6 months
Quality of Life Survey (QoL) - Treatment Impact
Time frame: 6 months
Quality of Life Survey (QoL) - Social or Vocational Worry
Time frame: 6 months
Quality of Life Survey (QoL) - Hypoglycemia Fear
Time frame: 6 months
Quality of Life Survey (QoL) - Glycemia Control Perception
Time frame: 6 months
Quality of Life Survey (QoL) - Lifestyle Flexibility
Time frame: 6 months
Quality of Life Survey (QoL) - Social Stigma
Time frame: 6 months
Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment
Time frame: 6 months
Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27273731Vanderheiden 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.
- Derived from this study: PubMed 26909799Vanderheiden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ildiko Lingvay, MD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide and Saline in people with Type 2 Diabetes Mellitus and Obesity, run by Ildiko Lingvay at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control Measured by HbA1c (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01505673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.