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Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

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: NCT00154401
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.
Study Start Date : January 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide




Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 14 weeks treatment ]

Secondary Outcome Measures :
  1. Body weight after 14 weeks.
  2. Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks.
  3. Safety and tolerability


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
  • Diet treated subjects: 7.5% < HbA1c < 10%
  • Single oral drug therapy subjects: 7.0% < HbA1c < 9.5%
  • Body Mass Index (BMI): max 40 kg/m^2

Exclusion Criteria:

  • Subjects treated with thiazolidinediones or insulin
  • Subjects with any serious medical conditions

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): NCT00154401


Locations
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Denmark
Novo Nordisk Investigational Site
Aalborg, Denmark, 9000
Novo Nordisk Investigational Site
Hellerup, Denmark, 2900
Novo Nordisk Investigational Site
Hvidovre, Denmark, 2650
Novo Nordisk Investigational Site
Kolding, Denmark, 6000
Novo Nordisk Investigational Site
København S, Denmark, 2300
Novo Nordisk Investigational Site
København, Denmark, 2400
Novo Nordisk Investigational Site
Køge, Denmark, 4600
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
France
Novo Nordisk Investigational Site
Antibes, France, 06600
Novo Nordisk Investigational Site
DAX, France, 40107
Novo Nordisk Investigational Site
LA ROCHELLE cedex, France, 17019
Novo Nordisk Investigational Site
Marseille, France, 13009
Novo Nordisk Investigational Site
Montpellier, France, 34295
Novo Nordisk Investigational Site
Mougins, France, 06250
Novo Nordisk Investigational Site
Narbonne, France, 11108
Novo Nordisk Investigational Site
NEVERS cedex, France, 58033
Novo Nordisk Investigational Site
Nimes, France, 30006
Novo Nordisk Investigational Site
Pessac, France, 33600
Novo Nordisk Investigational Site
Rennes, France, 35056
Novo Nordisk Investigational Site
Venissieux, France, 69200
Netherlands
Novo Nordisk Investigational Site
Amsterdam, Netherlands, 1105 AZ
Novo Nordisk Investigational Site
Apeldoorn, Netherlands, 7334 DZ
Novo Nordisk Investigational Site
Den Bosch, Netherlands, 5223 GV
Novo Nordisk Investigational Site
Den Haag, Netherlands, 2512 VA
Novo Nordisk Investigational Site
Groningen, Netherlands, 9713 GZ
Novo Nordisk Investigational Site
Hengelo, Netherlands, 7555 DL
Novo Nordisk Investigational Site
Sliedrecht, Netherlands, 3361 XV
Slovakia
Novo Nordisk Investigational Site
Banska Bystrica, Slovakia, 95717
Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 08
Novo Nordisk Investigational Site
Bratislava, Slovakia, 81526
Novo Nordisk Investigational Site
Bratislava, Slovakia, 82102
Novo Nordisk Investigational Site
Bratislava, Slovakia, 831 01
Novo Nordisk Investigational Site
Kosice, Slovakia, 040 01
Novo Nordisk Investigational Site
Kosice, Slovakia, 04011
Novo Nordisk Investigational Site
Kosice, Slovakia, 04190
Novo Nordisk Investigational Site
Lucenec, Slovakia, 98401
Novo Nordisk Investigational Site
Presov, Slovakia, 080 01
Novo Nordisk Investigational Site
Sahy, Slovakia, 93601
Novo Nordisk Investigational Site
Zilina, Slovakia, 01001
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00154401    
Other Study ID Numbers: NN2211-1571
First Posted: September 12, 2005    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
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists