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The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension


Phase 3
18 Years
80 Years
Not Enrolling
Both
Diabetes, Diabetes Mellitus, Type 2

Thank you

Trial Information

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Outcome Description:

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

Outcome Time Frame:

Week 0, Week 26

Safety Issue:

No

Principal Investigator

Anne Bloch Thomsen

Investigator Role:

Study Director

Investigator Affiliation:

Novo Nordisk

Authority:

United States: Food and Drug Administration

Study ID:

NN2211-1860

NCT ID:

NCT00700817

Start Date:

June 2008

Completion Date:

June 2010

Related Keywords:

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2

Name

Location

Novo Nordisk Clinical Trial Call CenterBirmingham, Alabama  35242
Novo Nordisk Clinical Trial Call CenterEscondido, California  92026
Novo Nordisk Clinical Trial Call CenterJacksonville, Florida  32216
Novo Nordisk Clinical Trial Call CenterAthens, Georgia  30606
Novo Nordisk Clinical Trial Call CenterHonolulu, Hawaii  96814
Novo Nordisk Clinical Trial Call CenterBoise, Idaho  83702
Novo Nordisk Clinical Trial Call CenterChicago, Illinois  60616
Novo Nordisk Clinical Trial Call CenterShawnee Mission, Kansas  66204
Novo Nordisk Clinical Trial Call CenterMetairie, Louisiana  70002
Novo Nordisk Clinical Trial Call CenterHyattsville, Maryland  20782
Novo Nordisk Clinical Trial Call CenterMinneapolis, Minnesota  55416-2699
Novo Nordisk Clinical Trial Call CenterCleveland, Mississippi  38732
Novo Nordisk Clinical Trial Call CenterSt. Peters, Missouri  63376
Novo Nordisk Clinical Trial Call CenterLas Vegas, Nevada  89109
Novo Nordisk Clinical Trial Call CenterBerlin, New Jersey  08009
Novo Nordisk Clinical Trial Call CenterNorthport, New York  11768
Novo Nordisk Clinical Trial Call CenterPinehurst, North Carolina  28374
Novo Nordisk Clinical Trial Call CenterCincinnati, Ohio  45245
Novo Nordisk Clinical Trial Call CenterEugene, Oregon  97404
Novo Nordisk Clinical Trial Call CenterNorristown, Pennsylvania  19401
Novo Nordisk Clinical Trial Call CenterKingsport, Tennessee  37660
Novo Nordisk Clinical Trial Call CenterArlington, Texas  76014
Novo Nordisk Clinical Trial Call CenterOgden, Utah  84403
Novo Nordisk Clinical Trial Call CenterSouth Burlington, Vermont  05403
Novo Nordisk Clinical Trial Call CenterNorfolk, Virginia  23502
Novo Nordisk Clinical Trial Call CenterMilwaukee, Wisconsin  53209