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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00701831
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : November 4, 2010
Information provided by:

June 18, 2008
June 19, 2008
November 4, 2010
May 2008
October 2010   (Final data collection date for primary outcome measure)
  • HbA1c, FBG [ Time Frame: after treatment end (6 months) ]
  • Final dose [ Time Frame: after treatment end (6 months) ]
  • Number of dose adjustment [ Time Frame: after treatment end (6 months) ]
  • Time to dose titration [ Time Frame: after treatment end (6 months) ]
Same as current
Complete list of historical versions of study NCT00701831 on Archive Site
  • Hypoglycemia [ Time Frame: after treatment end (6 months) ]
  • Noctural hypoglycemia [ Time Frame: after treatment end (6 months) ]
  • DTSQ [ Time Frame: after treatment end (6 months) ]
  • Physician Satisfaction Questionnaire [ Time Frame: after treatment end (6 months) ]
Same as current
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Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control
Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients

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
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Insulin glargine
The dose is titrated according to patient needs
Experimental: 1
Insulin glargine
Intervention: Drug: Insulin glargine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Trial Transparency Team, sanofi-aventis
Not Provided
Study Director: Zeynep Cetin Sanofi
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP