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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.
Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide | Experimental | Liraglutide, s.c., 1.8 mg, die, 24 weeks |
|
| Placebo | Placebo Comparator | Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Liraglutide will be compared to placebo for 24 weeks in a cross-over design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Changes in Glycemic Control by HbA1c. | To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c. | Measure changes in HbA1c at 24 and 52 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Changes on Adipose Tissue | To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue | Measure changes in the composite at 24 and 52 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley John Weisnagel, MD | CHU de Québec | Principal Investigator |
| Martin D'Amours, MD | CHU de Québec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Québec | Québec | G1V 4G2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28722271 | Derived | Dube MC, D'Amours M, Weisnagel SJ. Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):178-184. doi: 10.1111/dom.13063. Epub 2017 Sep 6. |
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individual data will not be available to other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide First, Then Placebo | Liraglutide, s.c., 1.8 mg, die, 24 weeks First Intervention (24 weeks)", "Washout (4 weeks)", and "Second Intervention (24 weeks |
| FG001 | Placebo First, the Liraglutide | subjects were submitted to placebo and liraglutide in a randomly manner |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (24 Weeks) |
| |||||||||||||
| Washout (4 Weeks) |
| |||||||||||||
| Second Intervention (24 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Patients beginning with liraglutide will be switched to Placebo and vice versa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Changes in Glycemic Control by HbA1c. | To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c. | Posted | Mean | Standard Deviation | percentage of HbA1c | Measure changes in HbA1c at 24 and 52 weeks from baseline |
|
1 yr
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide | Liraglutide, s.c., 1.8 mg, die, 24 weeks Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Weisnagel | CHU de Quebec | 4185254444 | 47035 | john.weisnagel@crchul.ulaval.ca |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D050177 | Overweight |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Placebos | Drug | placebo will be compared to liraglutide for 24 weeks in a cross-over design |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Assessment of Changes on Adipose Tissue | To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue | Not Posted | Dec 2017 | Measure changes in the composite at 24 and 52 weeks from baseline | Participants |
| 0 |
| 15 |
| 13 |
| 15 |
| EG001 | Placebo | Placebo visually identical to study drug will be given Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design | 0 | 15 | 0 | 15 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |