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To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together (LEAD-2)
This study has been completed.
Study NCT00318461   Information provided by Novo Nordisk
First Received: April 25, 2006   Last Updated: November 9, 2009   History of Changes

April 25, 2006
November 9, 2009
May 2006
November 2008   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c after 26 weeks of treatment.
Complete list of historical versions of study NCT00318461 on ClinicalTrials.gov Archive Site
  • Body weight [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Glycaemic control parameters (fasting plasma glucose, 7-point glucose profiles) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Beta-cell function [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Glycemic control parameters (fasting plasma glucose, -glucose profiles)
  • body weight
  • The 26 weeks double-blind period will be followed by an 18 months open label extension.
  • Βeta-cell function
  • Safety and tolerability.
 
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride.

The 26 weeks double-blind period will be followed by an 18 months open label extension.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Diabetes Mellitus, Type 2
  • Drug: liraglutide
  • Drug: metformin
  • Drug: glimepiride
  • Drug: placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1091
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes and treated with OAD(s) for at least 3 months
  • HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
  • Body Mass Index (BMI) less than or equal 40 kg/m2

Exclusion Criteria:

  • Subjects treated with insulin within the last three months
  • Subjects with any serious medical condition
  • Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
  • Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Bulgaria,   Croatia,   Denmark,   Germany,   Hungary,   India,   Ireland,   Italy,   Netherlands,   New Zealand,   Norway,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00318461
Public Access to Clinical Trials, Novo Nordisk A/S
NN2211-1572
Novo Nordisk
 
Study Director: Martin Lange Novo Nordisk
Novo Nordisk
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP