Primary outcomeMean· 6-months
Glycemic Control Measured by HbA1c
| Group | Value (Percent HbA1c) | Spread |
|---|---|---|
| Liraglutide | 7.9 | 1.1 |
| Saline Injection | 8.9 | 1.3 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataAdding Liraglutide to High Dose Insulin: Breaking the Cycle
NCTNCT01505673 (opens ClinicalTrials.gov in a new tab)Other idIIS-000235
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 71 participants (actual)
- Sponsor
- Ildiko Lingvay · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Jan 2012
- Primary completion
- Jun 2016
- Completion
- Jun 2016
- First posted
- 6 Jan 2012 (estimated)
- Last update posted
- 16 Jan 2018
- Conditions
- Type 2 Diabetes Mellitus · Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014201520162017
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LiraglutideDrug
- SalineDrug
Arms2
Active comparator
Liraglutide
Placebo comparator
Saline injection
Primary outcomes1
Outcomes the sponsor listed as primary.
Glycemic Control Measured by HbA1c
Time frame · 6-months
Registry description
HbA1c (%)
Secondary outcomes(20)
Pancreatic and Hepatic Triglyceride Content
Time frame · 6-months
Registry description
Liver Triglyceride and Pancreatic Triglyceride
Weight
Time frame · 6-months
Beta-Cell Function
Time frame · 6-months
Registry description
Fasting Glucose as a Measure of Beta-Cell Function
Glucagon
Time frame · 6-months
Registry description
Measured during mixed meal challenge test.
Total Daily Insulin Dose
Time frame · 6-months
Registry description
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
Time frame · 6-months
Registry description
The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month.
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
Registry 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
Quality of Life Survey (QoL) - General Health Perception
Time frame · 6-months
Registry 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.
Beta-Cell Function
Time frame · 6 months
Registry description
Fasting C-peptide as a Measure of Beta-Cell Function
Matsuda Index as a Measure of Beta Cell Function
Time frame · 6 months
Registry 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.
Beta-cell Function
Time frame · 6 Months
Registry description
AUC c-peptide
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
Registry 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.
Quality of Life Survey (QoL) - Treatment Satisfaction
Time frame · 6 months
Registry 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.
Quality of Life Survey (QoL) - Treatment Impact
Time frame · 6 months
Registry 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.
Quality of Life Survey (QoL) - Social or Vocational Worry
Time frame · 6 months
Registry 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· 6-months
Pancreatic and Hepatic Triglyceride Content
| Group | Value (Percent Triglyceride) | Spread |
|---|---|---|
| Liraglutide | 12.3 | 5.8 |
| Saline Injection | 12.2 | 7.8 |
Secondary outcomeMean· 6-months
Weight
| Group | Value (Kilograms) | Spread |
|---|---|---|
| Liraglutide | 114 | 21 |
| Saline Injection | 117 | 27 |
Secondary outcomeMean· 6-months
Beta-Cell Function
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Liraglutide | 179 | 75 |
| Saline Injection | 197 | 98 |
Secondary outcomeMean· 6-months
Glucagon
| Group | Value (pg/mL) | Spread |
|---|---|---|
| Liraglutide | 107.3 | 44.5 |
| Saline Injection | 93.8 | 37.8 |
Secondary outcomeMedian· 6-months
Total Daily Insulin Dose
| Group | Value (IU) |
|---|---|
| Liraglutide | 200 |
| Saline Injection | 218 |
Secondary outcomeMean· 6-months
Number of Daily Injections
| Group | Value (number/day) | Spread |
|---|---|---|
| Liraglutide | 3.7 | 1.4 |
| Saline Injection | 3.8 | 1.3 |
Secondary outcomeMean· 6-months
Blood Pressure
| Group | Value (mmHg) | Spread |
|---|---|---|
| Liraglutide | 134 | 18 |
| Saline Injection | 135 | 17 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LiraglutideLiraglutide: Liraglutide 1.8mg injected subcutaneously from pen device once daily for 6-months | 0 / 35 | 1 / 35 | 14 / 35 |
| Saline InjectionSaline: Placebo injection of 1.8mg saline once daily for 6-months | 0 / 36 | 6 / 36 | 14 / 36 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
2 studies on this page
Indexing hint: Randomized controlled trial · 2016
9 results
Mechanisms of Action of Liraglutide in Patients With Type 2 Diabetes Treated With High-Dose Insulin.
Vanderheiden et al. 2016The Journal of clinical endocrinology and metabolismcited by 62
PMID 26909799DOI 10.1210/jc.2015-3906PUB-26909799
Full text at the publisher9 results
Indexing hint: Randomized controlled trial · 2016
8 results
Effect of Adding Liraglutide vs Placebo to a High-Dose lnsulin Regimen in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
Vanderheiden et al. 2016JAMA internal medicinecited by 33
PMID 27273731DOI 10.1001/jamainternmed.2016.1540PUB-27273731
Full text at the publisher8 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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