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

Diabetes Mellitus, Type 2 Clinical Trial

— LANTIT  

Official title:

Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701831
• Other study ID #: LANTU_L_03502
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2008
• Last updated: November 3, 2010
• Start date: May 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine
The dose is titrated according to patient needs

Locations

Country	Name	City	State
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c, FBG		after treatment end (6 months)	No
Primary	Final dose		after treatment end (6 months)	No
Primary	Number of dose adjustment		after treatment end (6 months)	No
Primary	Time to dose titration		after treatment end (6 months)	No
Secondary	Hypoglycemia		after treatment end (6 months)	Yes
Secondary	Noctural hypoglycemia		after treatment end (6 months)	Yes
Secondary	DTSQ		after treatment end (6 months)	No
Secondary	Physician Satisfaction Questionnaire		after treatment end (6 months)	No