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Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00331851
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: insulin glargine Drug: metformin Drug: glimepiride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.
Study Start Date : May 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 26 weeks of treatment ]

Secondary Outcome Measures :
  1. body weight
  2. Safety and tolerability
  3. Beta-cell function
  4. Glycaemic control

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes
  • Treatment with oral anti-diabetic drugs for at least 3 months
  • HbA1c: 7.5-10.0 % (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 to 45 kg/m2

Exclusion Criteria:

  • Treatment with insulin within the last 3 months
  • Treatment with any drug that could interfere with the glucose level
  • Any serious medical condition
  • Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331851

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Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00331851    
Other Study ID Numbers: NN2211-1697
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors