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

July 16, 2014 updated by: Sanofi

Practical Implementation of ADA/EASD Consensus Algorithm in Patients With Type 2 Diabetes: Timely Insulin Initiation and Titration

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • C.a.b.a., Argentina, C1050AAK
        • Investigational Site Number 10
      • C.a.b.a., Argentina, C1419AHN
        • Investigational Site Number 14
      • C.a.b.a., Argentina
        • Investigational Site Number 01
      • C.a.b.a., Argentina
        • Investigational Site Number 11
      • C.a.b.a., Argentina
        • Investigational Site Number 12
      • C.a.b.a., Argentina
        • Investigational Site Number 17
      • C.a.b.a., Argentina
        • Investigational Site Number 9
      • Caba, Argentina
        • Investigational Site Number 03
      • Caba, Argentina
        • Investigational Site Number 06
      • Caba, Argentina
        • Investigational Site Number 15
      • Caba, Argentina
        • Investigational Site Number 16
      • Caba, Argentina
        • Investigational Site Number 18
      • Capital Federal, Argentina
        • Investigational Site Number 26
      • Mar del Plata, Argentina, 7600
        • Investigational Site Number 22
      • Mar del Plata, Argentina, B7602CBM
        • Investigational Site Number 13
      • Mar del Plata, Argentina
        • Investigational Site Number 02
      • Moreno -Pcia. de Bs. As.-, Argentina
        • Investigational Site Number 021
      • Morón, Argentina
        • Investigational Site Number 07
      • Paraná, Argentina
        • Investigational Site Number 04
      • Salta, Argentina
        • Investigational Site Number 8
      • Sarandí, Argentina
        • Investigational Site Number 05
      • Tandil, Argentina, 7000
        • Investigational Site Number 20
      • Zárate, Argentina, 2800
        • Investigational Site Number 25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with a diagnosis of type 2 diabetes for more than 6 months
  • Patients treated with Oral AntiDiabetics (OADs monotherapy or combination) with an HbA1c >7% and <10% and/or treated with NPH insulin with HbA1c >7% and <10% or treated with NPH insulin who have experienced severe and/or nocturnal hypoglycemia in the last 6 months.
  • Ability to perform SMBS and insulin self-titration under the physicians guidance.
  • Body Mass Index (BMI) >21 kg/ m2.
  • Signature of informed consent.

Exclusion criteria:

  • Hospitalized patients.
  • Pregnant women or with the intention of becoming pregnant.
  • Unexplained weight loss of more than 10% in the last 6 months.
  • Women with child bearing potential not using effective contraceptive methods.
  • Women in breast feeding period.
  • Patients on chronic treatment with systemic corticosteroids or protease inhibitors.
  • History of drug or alcohol abuse.
  • Diabetic retinopathy with surgical treatment in 3 months previous to study entry or patients that could require surgical treatment in the following 6 months to study entry.
  • Major systemic disease clinically important that would interfere with implementation or interpretation of the study, at the discretion of the investigator.
  • Renal failure known as creatinine > 1.4 mg/dl in women and > 1.5 mg/dl in men.
  • Known hypersensitivity to glargine or any of its excipients.
  • Patients with history of hospitalization due to cardiovascular event, cardiovascular procedure in the past 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Glycosylated Haemoglobin (HbA1c)
Time Frame: From week 0 (baseline) to week 24 (end of study)
From week 0 (baseline) to week 24 (end of study)
Dose and timing of insulin glargine
Time Frame: From week 0 (baseline) to week 24 (end of study)
From week 0 (baseline) to week 24 (end of study)
Hypoglycemic episodes
Time Frame: From week 0 (baseline) to week 24 (end of study)
From week 0 (baseline) to week 24 (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LANTU_L_04980
  • U1111-1116-9268 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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