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

May 19, 2010
July 16, 2014
May 2010
June 2013   (final data collection date for 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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01127269 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes
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)
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
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)
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.

Intervention: Drug: INSULIN GLARGINE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
June 2013
June 2013   (final data collection date for primary outcome measure)

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.

Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01127269
LANTU_L_04980, U1111-1116-9268
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP