The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
Completed · Phase 3
Conditions studied: Diabetes, Diabetes Mellitus, Type 2
In brief
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. The extension will consist of two 26-week periods: 1. Week 27-52 after randomisation \- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen. 2. Week 53-78 after randomisation * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals. * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
Key facts
- Study ID
- NCT00700817
- Run by
- Novo Nordisk A/S
- People needed
- 665
- Starts
- 2008-06-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2017-03-08
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 2 diabetes
- Treatment with metformin alone for at least three months
- HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
- Body Mass Index (BMI) less than or equal to 45.0
You may not qualify if…
- Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
- Treatment with anti-diabetic drugs other than metformin within the last three months
- Any serious medical condition
- Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
Where it is running
- Novo Nordisk Investigational Site — Escondido, California, United States
- Novo Nordisk Investigational Site — Fresno, California, United States
- Novo Nordisk Investigational Site — Huntington Beach, California, United States
- Novo Nordisk Investigational Site — Long Beach, California, United States
- Novo Nordisk Investigational Site — Northridge, California, United States
- Novo Nordisk Investigational Site — Orange, California, United States
- Novo Nordisk Investigational Site — Poway, California, United States
- Novo Nordisk Investigational Site — Walnut Creek, California, United States
- Novo Nordisk Investigational Site — Denver, Colorado, United States
- Novo Nordisk Investigational Site — Crystal River, Florida, United States
- Novo Nordisk Investigational Site — Jacksonville, Florida, United States
- Novo Nordisk Investigational Site — Jacksonville, Florida, United States
- Novo Nordisk Investigational Site — Miami, Florida, United States
- Novo Nordisk Investigational Site — Ocala, Florida, United States
- Novo Nordisk Investigational Site — Panama City, Florida, United States
- Novo Nordisk Investigational Site — Saint Cloud, Florida, United States
- Novo Nordisk Investigational Site — Athens, Georgia, United States
- Novo Nordisk Investigational Site — Atlanta, Georgia, United States
- Novo Nordisk Investigational Site — Dunwoody, Georgia, United States
- Novo Nordisk Investigational Site — Lithia Springs, Georgia, United States
- Novo Nordisk Investigational Site — Honolulu, Hawaii, United States
- Novo Nordisk Investigational Site — Boise, Idaho, United States
- Novo Nordisk Investigational Site — Chicago, Illinois, United States
- Novo Nordisk Investigational Site — Shawnee Mission, Kansas, United States
- Novo Nordisk Investigational Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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