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

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ClinicalTrials.gov Identifier: NCT00701831
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : November 4, 2010
Sponsor:
Information provided by:
Sanofi

Brief Summary:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Insulin glargine
Drug: Insulin glargine
The dose is titrated according to patient needs



Primary Outcome Measures :
  1. HbA1c, FBG [ Time Frame: after treatment end (6 months) ]
  2. Final dose [ Time Frame: after treatment end (6 months) ]
  3. Number of dose adjustment [ Time Frame: after treatment end (6 months) ]
  4. Time to dose titration [ Time Frame: after treatment end (6 months) ]

Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: after treatment end (6 months) ]
  2. Noctural hypoglycemia [ Time Frame: after treatment end (6 months) ]
  3. DTSQ [ Time Frame: after treatment end (6 months) ]
  4. Physician Satisfaction Questionnaire [ Time Frame: after treatment end (6 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


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): NCT00701831


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

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00701831     History of Changes
Other Study ID Numbers: LANTU_L_03502
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: November 2010

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