CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 467 enrolled
Drug / intervention
liraglutide +1 moredrug
Likely dose
Liraglutide 1.8 mg once daily subcutaneously or exenatide 10 mcg twice daily subcutaneouslyAI-extracted
Key inclusion· 4
  • ✓Type 2 diabetes mellitus
  • ✓Stable treatment with metformin, sulphonylurea, or both for at least 3 months
  • ✓HbA1C between 7.0% and 11.0%
  • ✓BMI ≤45 kg/m²
Key exclusion· 7
  • ✕Prior insulin therapy
  • ✕Any anti-diabetic drug other than metformin and sulphonylurea
  • ✕Prior exposure to exenatide or liraglutide
  • ✕Impaired liver and/or renal function

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00518882
NCT00518882Phase 3Completed
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Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Aug 21, 2007·Updated Mar 8, 2017

In Brief

A Phase 3 clinical trial evaluating liraglutide and exenatide for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 467 participants across 125 sites in 16 countries.

Detailed Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAustria, Denmark, Finland, France, Germany, Ireland, North Macedonia, Norway, Poland, Puerto Rico, Romania, Slovenia, Spain, Sweden, Switzerland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 21, 2007
Enrollment StartAug 1, 2007
Primary CompletionApr 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.9 years ago

Interventions

liraglutidedrug

1.8 mg once daily for s.c. (under the skin) injection.

exenatidedrug

10 mcg twice daily for s.c. (under the skin) injection.