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

June 18, 2008
November 3, 2010
May 2008
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00701831 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00701831
LANTU_L_03502
Not Provided
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: Zeynep Cetin Sanofi
Sanofi
November 2010

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