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

Diabetes Mellitus, Type 2 Clinical Trial

— AFICIONADO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127269
• Other study ID #: LANTU_L_04980
• Secondary ID: U1111-1116-9268
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2010
• Last updated: July 16, 2014
• Start date: May 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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)

Locations

Country	Name	City	State
Argentina	Investigational Site Number 01	C.a.b.a.
Argentina	Investigational Site Number 10	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 14	C.a.b.a.
Argentina	Investigational Site Number 17	C.a.b.a.
Argentina	Investigational Site Number 9	C.a.b.a.
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	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	Investigational Site Number 22	Mar del Plata
Argentina	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	Investigational Site Number 25	Zárate

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.		From week 0 (baseline) to week 24 (end of study)	No
Secondary	Glycosylated Haemoglobin (HbA1c)		From week 0 (baseline) to week 24 (end of study)	No
Secondary	Dose and timing of insulin glargine		From week 0 (baseline) to week 24 (end of study)	No
Secondary	Hypoglycemic episodes		From week 0 (baseline) to week 24 (end of study)	Yes