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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin glargine

• Registration Number: NCT00701831
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-03
• Last Update Posted: 2010-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Insulin glargine	Insulin glargine

Primary Outcome Measures

Name	Time	Method
Number of dose adjustment	after treatment end (6 months)
Time to dose titration	after treatment end (6 months)
Final dose	after treatment end (6 months)
HbA1c, FBG	after treatment end (6 months)

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia	after treatment end (6 months)
Noctural hypoglycemia	after treatment end (6 months)
DTSQ	after treatment end (6 months)
Physician Satisfaction Questionnaire	after treatment end (6 months)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇷 Istanbul, Turkey