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Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-1)

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: NCT00318422
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1041 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.
Study Start Date : May 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

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Arms and Interventions
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Outcome Measures
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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. Glycemic control parameters (fasting plasma glucose, -glucose profiles)

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Treatment with oral anti-diabetic drugs 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 to 45.0 kg/m2.

Exclusion Criteria:

  • Treatment with insulin within the last three months
  • Treatment with any drug that could interfere with the glucose level
  • Any serious medical condition
  • Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
Contacts and Locations
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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): NCT00318422


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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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: NCT00318422    
Other Study ID Numbers: NN2211-1436
2005-003414-15 ( EudraCT Number )
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: January 25, 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
Liraglutide
Glimepiride
Rosiglitazone
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors