Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus
This study has been terminated.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00349986
  Purpose

The rationale of the study is to determine:

  • the first dose and the titration of basal insulin
  • the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insuline glargine
Phase IV

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin Insulin glargine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • HgbA1c measurement

Enrollment: 7
Study Start Date: May 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
  • BMI >25 kg/m2 , <30 kg/m2
  • HbA1c value >7.0%, <9.0% within one month

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Known malignancy
  • Drug or alcohol abuse
  • Severe liver disease
  • Renal failure (se Creatinine > 150 micro mol/l)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349986

Locations
Hungary
Sanofi-Aventis
Budapest, Hungary
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: László Erős, MD Sanofi-Aventis
  More Information

Study results  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: HOE901_4059
Study First Received: July 7, 2006
Last Updated: September 28, 2008
ClinicalTrials.gov Identifier: NCT00349986  
Health Authority: Hungary: National Institute of Pharmacy

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009