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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01127269
• Date of registration: 19/05/2010
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes AFICIONADO
• Scientific title: Practical Implementation of ADA/EASD Consensus Algorithm in Patients With Type 2 Diabetes: Timely Insulin Initiation and Titration
• Date of first enrolment: May 2010
• Target sample size: 178
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01127269
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Argentina

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: INSULIN GLARGINE

Primary Outcome(s)

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)]

Secondary Outcome(s)

Dose and timing of insulin glargine [Time Frame: From week 0 (baseline) to week 24 (end of study)]

Glycosylated Haemoglobin (HbA1c) [Time Frame: From week 0 (baseline) to week 24 (end of study)]

Hypoglycemic episodes [Time Frame: From week 0 (baseline) to week 24 (end of study)]

Secondary ID(s)

U1111-1116-9268

LANTU_L_04980

Source(s) of Monetary Support

Please refer to primary and secondary sponsors