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LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00349986
Recruitment Status : Terminated (prematurely terminated due to loss of interest)
First Posted : July 10, 2006
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insuline glargine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. HgbA1c measurement

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00349986


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

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00349986     History of Changes
Other Study ID Numbers: HOE901_4059
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs