Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Study Overview
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Brief Summary
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Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.

Official Title
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Phase 3 Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes BMI≤45 kg/m2 A1c ≥7.5% and ≤10.5% Exclusion Criteria: type 1 diabetes symptoms of poorly controlled diabetes eGFR <50 ml/min/1.73m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: liraglutide<br>liraglutide 1.8 mg injected once daily | Drug: liraglutide<br>* liraglutide titrated to 1.8 mg sc daily<br>* Other names: Victoza;|
| Placebo Comparator: Placebo injection<br> | Drug: placebo injection<br>* placebo injected sc daily volume equal to active comparator<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1c |  | Baseline to 24 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients experiencing hypoglycemia |  | Baseline and 24 weeks | 
| Change in Systolic Blood pressure |  | Baseline and 24 weeks | 
| Change in diastolic blood pressure |  | Baseline and 24 weeks | 
| Change in waist circumference |  | Baseline and 24 weeks | 
| Change in body weight |  | Baseline and 24 weeks | 
| Change in heart rate |  | Baseline and 24 weeks | 
| Change in lipid profile |  | Baseline and 24 weeks | 
| Diabetes Treatment Satisfaction |  | Baseline, 12 weeks and 24 weeks | 
| Percentage of patients achieving A1C < or equal to 7% |  | Baseline and 24 weeks | 
| Change in fasting blood glucose |  | Baseline adn 24 weeks | 
| Occurence of undetected hypoglycemia as measured by continuous glucose monitoring |  | Baseline, 12 weeks and 24 weeks | 
| Postprandial glucose reduction through measurement of 7 point glucose profile |  | Baseline, 4 weeks, 12 weeks and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin