Primary outcome
What LIDO measured first
| Liraglutiden=15 | Placebon=15 |
|---|---|
| 0.3(0.1) | 0.2(0.1) |
Phase 4 · Liraglutide
LIDO trial results
Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
Assessment of Changes in Glycemic Control by HbA1c. (percentage of HbA1c), Measure changes in HbA1c at 24 and 52 weeks from baseline. Liraglutide: 0.3; Placebo: 0.2.
- Participants
- 15
- Status
- completed
- Completed
- 2015-04
- Sponsor
- CHU de Quebec-Universite Laval
As posted on ClinicalTrials.gov (NCT01787916), updated at source Jan 5, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in LIDO
Percent of participants affected, 1 yr. The most common events the registry lists.
| Event | Liraglutide | Placebo |
|---|---|---|
| Any serious event | 0% | 0% |
| nausea | 86.7% | 0% |
The trial
How LIDO was run
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.
- Liraglutide: Liraglutide, s.c., 1.8 mg, die, 24 weeks
- Placebo: Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
Who could join the trial
Inclusion Criteria: * type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years Exclusion Criteria: * diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis
Published papers
Papers from LIDO
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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