AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 4AFICIONADONCT01127269

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

A Phase 4 study testing INSULIN GLARGINE in people with Diabetes Mellitus, Type 2, run by Sanofi at 23 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
INSULIN GLARGINE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
23 sitesArgentina
Study dates
May 2010to Jun 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Argentina23 sites

  • Investigational Site Number 10

    C.a.b.a., C1050AAK

  • Investigational Site Number 14

    C.a.b.a., C1419AHN

  • Investigational Site Number 01

    C.a.b.a.

  • Investigational Site Number 11

    C.a.b.a.

  • Investigational Site Number 12

    C.a.b.a.

  • Investigational Site Number 17

    C.a.b.a.

  • Investigational Site Number 9

    C.a.b.a.

  • Investigational Site Number 03

    Caba

  • Investigational Site Number 06

    Caba

  • Investigational Site Number 15

    Caba

  • Investigational Site Number 16

    Caba

  • Investigational Site Number 18

    Caba

  • Investigational Site Number 26

    Capital Federal

  • Investigational Site Number 22

    Mar del Plata, 7600

  • Investigational Site Number 13

    Mar del Plata, B7602CBM

  • Investigational Site Number 02

    Mar del Plata

  • Investigational Site Number 021

    Moreno -Pcia. de Bs. As.-

  • Investigational Site Number 07

    Morón

  • Investigational Site Number 04

    Paraná

  • Investigational Site Number 8

    Salta

  • Investigational Site Number 05

    Sarandí

  • Investigational Site Number 20

    Tandil, 7000

  • Investigational Site Number 25

    Zárate, 2800

Other trials in Argentina

About this study

Official title: 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)
Being tested
INSULIN GLARGINE
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSULIN GLARGINEDrug

    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)

Study groups in NCT01127269
Study groupRoleWhat they receive
Insulin GlargineExperimentalPatients 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.
Receives: Drug: INSULIN GLARGINE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.

    Measured: From week 0 (baseline) to week 24 (end of study)

Secondary outcomes (3)

  1. Glycosylated Haemoglobin (HbA1c)

    Measured: From week 0 (baseline) to week 24 (end of study)

  2. Dose and timing of insulin glargine

    Measured: From week 0 (baseline) to week 24 (end of study)

  3. Hypoglycemic episodes

    Measured: From week 0 (baseline) to week 24 (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01127269
Sponsor's protocol ID
LANTU_L_04980
Other IDs
U1111-1116-9268
Acronym
AFICIONADO
Status last verified
Jul 2014
First submitted
19 May 2010
Last updated
17 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing INSULIN GLARGINE in people with Diabetes Mellitus, Type 2, run by Sanofi at 23 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01127269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in