Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: INSULIN GLARGINE

• Registration Number: NCT01127269
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months

Secondary Objectives:

* Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months

* Insulin glargine dose at 3 and 6 months

* Hypoglycemic episodes (all types)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin Glargine	INSULIN GLARGINE	Patients will receive insulin glargine titrated based on standard of care as recommended by the ADA/EASD Consensus Algorithm. Step 1: insulin glargine initiation regimen for insulin naive patients/ Switch to insulin glargine for patient already treated with basal insulin. Step 2: the insulin dosage of patients will be titrated according to the ADA/EASD Consensus Algorithm.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.	From week 0 (baseline) to week 24 (end of study)

Secondary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin (HbA1c)	From week 0 (baseline) to week 24 (end of study)
Dose and timing of insulin glargine	From week 0 (baseline) to week 24 (end of study)
Hypoglycemic episodes	From week 0 (baseline) to week 24 (end of study)

Trial Locations

Locations (23)

Investigational Site Number 14; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 10; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 11; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 01; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 17; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 12; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 13; 🇦🇷 Mar del Plata, Argentina

Investigational Site Number 9; 🇦🇷 C.a.b.a., Argentina

Investigational Site Number 03; 🇦🇷 Caba, Argentina

Investigational Site Number 02; 🇦🇷 Mar del Plata, Argentina

Investigational Site Number 18; 🇦🇷 Caba, Argentina

Investigational Site Number 07; 🇦🇷 Morón, Argentina

Investigational Site Number 25; 🇦🇷 Zárate, Argentina

Investigational Site Number 06; 🇦🇷 Caba, Argentina

Investigational Site Number 15; 🇦🇷 Caba, Argentina

Investigational Site Number 16; 🇦🇷 Caba, Argentina

Investigational Site Number 04; 🇦🇷 Paraná, Argentina

Investigational Site Number 8; 🇦🇷 Salta, Argentina

Investigational Site Number 26; 🇦🇷 Capital Federal, Argentina

Investigational Site Number 22; 🇦🇷 Mar del Plata, Argentina

Investigational Site Number 20; 🇦🇷 Tandil, Argentina

Investigational Site Number 021; 🇦🇷 Moreno -Pcia. de Bs. As.-, Argentina

Investigational Site Number 05; 🇦🇷 Sarandí, Argentina