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The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

NCT00700817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 665

Last updated 2017-03-08

Study results available
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Summary

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.

Conditions

Interventions

DRUG

liraglutide

1.2 mg once daily, subcutaneous (under the skin) injection

DRUG

sitagliptin

Tablets, 100 mg daily

DRUG

metformin

Tablets, minimum 1500 mg daily

DRUG

liraglutide

1.8 mg once daily, subcutaneous (under the skin) injection

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-06-30
Completion
2010-06-30

Countries

  • United States
  • Canada
  • Croatia
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Puerto Rico
  • Romania
  • Serbia and Montenegro
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00700817 on ClinicalTrials.gov