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Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control (LANTIT)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00701831
First received: June 18, 2008
Last updated: November 3, 2010
Last verified: November 2010
History of Changes
  Purpose

Primary objective:

  • To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients

Secondary objectives:

  • To assess the forced titration on physician and patient satisfaction
  • To evaluate the impact of training tools by means of patient profile

Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin glargine
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • HbA1c, FBG [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]
  • Final dose [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]
  • Number of dose adjustment [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]
  • Time to dose titration [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycemia [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: Yes ]
  • Noctural hypoglycemia [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: Yes ]
  • DTSQ [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]
  • Physician Satisfaction Questionnaire [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]

Enrollment: 241
Study Start Date: May 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Insulin glargine
 Drug: Insulin glargine
The dose is titrated according to patient needs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T2 insulin naïve patients
  • Patients whom their physician is considering initiation of Lantus treatment
  • Poor glycemic control 7,5 %10 %
  • T2 treatment with OADs more than 3 months
  • BMI<40 kg/m2

Exclusion Criteria:

  • Impaired renal function (Cr>2mg/dl or current renal dialysis)
  • Acute or chronic metabolic acidosis
  • Active liver disease or serum ALT or AST >2,5 than normal
  • History of hypoglycemia unawareness
  • Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
  • Pregnancy, breast feeding

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: NCT00701831

Locations
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Zeynep Cetin Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00701831     History of Changes
Other Study ID Numbers: LANTU_L_03502
Study First Received: June 18, 2008
Last Updated: November 3, 2010
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013