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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00318422
First received: April 25, 2006
Last updated: November 21, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: rosiglitazone
Drug: glimepiride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body weight [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: No ]
  • beta-cell function [ Designated as safety issue: No ]
  • Glycemic control parameters (fasting plasma glucose, -glucose profiles) [ Designated as safety issue: No ]

Enrollment: 1041
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318422

  Show 21 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, Ph.D Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00318422     History of Changes
Other Study ID Numbers: NN2211-1436, 2005-003414-15
Study First Received: April 25, 2006
Last Updated: November 21, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Taiwan: Department of Health
Spain: Spanish Agency of Medicines
Croatia: Ministry of Health and Social Care
Turkey: Ministry of Health Drug and Pharmaceutical Department
Poland: Ministry of Health
Romania: National Medicines Agency
Finland: Finnish Medicines Agency
South Africa: Medicines Control Council
Czech Republic: State Institute for Drug Control
New Zealand: Food Safety Authority
South Korea: Korea Food and Drug Administration (KFDA)
Israel: Israeli Health Ministry Pharmaceutical Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Brazil: National Health Surveillance Agency
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Switzerland: Swissmedic
Philippines: Bureau of Food and Drugs
Australia: Department of Health and Ageing Therapeutic Goods Administration
Greece: National Organization for Medicines
Thailand: Ministry of Public Health
India: Ministry of Health
Malaysia: Ministry of Health
Hong Kong: Department of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Rosiglitazone
Liraglutide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014