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Phase 4 Completed N=15 Randomized Quadruple-blind Treatment

52 Week Trial of Liraglutide in Type 1 Diabetes

Source: ClinicalTrials.gov NCT01787916 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Assessment of Changes in Glycemic Control by HbA1c. — 0.3; 0.2 percentage of HbA1c
◆ Published Evidence
Established
36citations · ~5 / year
Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes.
Diabetes, obesity & metabolism · 2018 · Likely link

Summary

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.

Linked Publications

  • Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes.
    Diabetes, obesity & metabolism · 2018 · 36 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Assessment of Changes in Glycemic Control by HbA1c.
0.3; 0.2
SECONDARY
Assessment of Changes on Adipose Tissue

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01787916) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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