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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00331851
First received: May 30, 2006
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: insulin glargine
Drug: metformin
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-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.

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 ]
  • Glycaemic control [ Designated as safety issue: No ]

Enrollment: 584
Study Start Date: May 2006
Primary Completion Date: April 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: 7.5-10.0 % (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
  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: NCT00331851

  Show 17 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: NCT00331851     History of Changes
Other Study ID Numbers: NN2211-1697
Study First Received: May 30, 2006
Last Updated: December 11, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Slovakia: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of Health
Denmark: Danish Medicines Agency
Poland: Ministry of Health
Finland: Finnish Medicines Agency
San Marino: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Netherlands: Dutch Health Care Inspectorate
Austria: Federal Ministry for Health and Women
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Brazil: National Health Surveillance Agency
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Philippines: Bureau of Food and Drugs
Norway: Norwegian Medicines Agency
India: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 22, 2014