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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014