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

NCT01127269 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2014-07-17

No results posted yet for this study

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)

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

INSULIN GLARGINE

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01127269 on ClinicalTrials.gov