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TOLEDDO: Effect of weekly GLP1 agonist treatment in "double diabetes": a randomized, open-label study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514906-30-00
Acronym
TOLEDDO
Enrollment
76
Registered
2024-07-11
Start date
2024-10-14
Completion date
Unknown
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

"double diabetes"

Brief summary

Percentage of time spent in glycemic target range (0.70-1.80 g/l) between D0 and D180.

Detailed description

HbA1c, Weight, waist circumference, Daily dose of insulin administered, Glycemic variability, assessed on data from continuous glucose recording using a continuous glucose meter (Free Style Libre, Guardian or Dexcom) by Standard Deviation (SD) and Mean Amplitude of Glycemic Excursions (MAGE). We will look at the variation in each criterion between the 2 groups between t0 and t6 months, between t0 and 3 months and between t3 months and t6 months., interstitial glucose time < 0.7 g/l and <0.54 g/l (Free Style Libre data), Percentage of adverse events in the 2 groups

Interventions

Sponsors

Centre Hospitalier Universitaire De Dijon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of time spent in glycemic target range (0.70-1.80 g/l) between D0 and D180.

Secondary

MeasureTime frame
HbA1c, Weight, waist circumference, Daily dose of insulin administered, Glycemic variability, assessed on data from continuous glucose recording using a continuous glucose meter (Free Style Libre, Guardian or Dexcom) by Standard Deviation (SD) and Mean Amplitude of Glycemic Excursions (MAGE). We will look at the variation in each criterion between the 2 groups between t0 and t6 months, between t0 and 3 months and between t3 months and t6 months., interstitial glucose time < 0.7 g/l and <0.54 g/l (Free Style Libre data), Percentage of adverse events in the 2 groups

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026