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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01127269
First received: May 19, 2010
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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)

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: INSULIN GLARGINE
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Practical Implementation of ADA/EASD Consensus Algorithm in Patients With Type 2 Diabetes: Timely Insulin Initiation and Titration

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycosylated Haemoglobin (HbA1c) [ Time Frame: From week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: No ]
  • Dose and timing of insulin glargine [ Time Frame: From week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: No ]
  • Hypoglycemic episodes [ Time Frame: From week 0 (baseline) to week 24 (end of study) ] [ Designated as safety issue: Yes ]

Enrollment: 178
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127269

Locations
Argentina
Investigational Site Number 9
C.a.b.a., Argentina
Investigational Site Number 12
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 10
C.a.b.a., Argentina, C1050AAK
Investigational Site Number 17
C.a.b.a., Argentina
Investigational Site Number 14
C.a.b.a., Argentina, C1419AHN
Investigational Site Number 18
Caba, Argentina
Investigational Site Number 16
Caba, Argentina
Investigational Site Number 03
Caba, Argentina
Investigational Site Number 06
Caba, Argentina
Investigational Site Number 15
Caba, Argentina
Investigational Site Number 26
Capital Federal, Argentina
Investigational Site Number 02
Mar del Plata, Argentina
Investigational Site Number 13
Mar del Plata, Argentina, B7602CBM
Investigational Site Number 22
Mar del Plata, Argentina, 7600
Investigational Site Number 021
Moreno -Pcia. de Bs. As.-, Argentina
Investigational Site Number 07
Morón, Argentina
Investigational Site Number 04
Paraná, Argentina
Investigational Site Number 8
Salta, Argentina
Investigational Site Number 05
Sarandí, Argentina
Investigational Site Number 20
Tandil, Argentina, 7000
Investigational Site Number 25
Zárate, Argentina, 2800
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01127269     History of Changes
Other Study ID Numbers: LANTU_L_04980, U1111-1116-9268
Study First Received: May 19, 2010
Last Updated: July 16, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014