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

NCT01127269 | Completed Phase 4

• 2 other identifiers: LANTU_L_04980U1111-1116-9268
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 23

Brief 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)

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Glycosylated Haemoglobin (HbA1c)

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

• Dose and timing of insulin glargine

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

• Hypoglycemic episodes

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

Study Arms (1)

Insulin Glargine

EXPERIMENTAL

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

Interventions

INSULIN GLARGINE DRUG

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)

Insulin Glargine

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (23)

Investigational Site Number 10

C.a.b.a., C1050AAK, Argentina

Location

Investigational Site Number 14

C.a.b.a., C1419AHN, Argentina

Location

Investigational Site Number 01

C.a.b.a., Argentina

Location

Investigational Site Number 11

C.a.b.a., Argentina

Location

Investigational Site Number 12

C.a.b.a., Argentina

Location

Investigational Site Number 17

C.a.b.a., Argentina

Location

Investigational Site Number 9

C.a.b.a., Argentina

Location

Investigational Site Number 03

Caba, Argentina

Location

Investigational Site Number 06

Caba, Argentina

Location

Investigational Site Number 15

Caba, Argentina

Location

Investigational Site Number 16

Caba, Argentina

Location

Investigational Site Number 18

Caba, Argentina

Location

Investigational Site Number 26

Capital Federal, Argentina

Location

Investigational Site Number 22

Mar del Plata, 7600, Argentina

Location

Investigational Site Number 13

Mar del Plata, B7602CBM, Argentina

Location

Investigational Site Number 02

Mar del Plata, Argentina

Location

Investigational Site Number 021

Moreno -Pcia. de Bs. As.-, Argentina

Location

Investigational Site Number 07

Morón, Argentina

Location

Investigational Site Number 04

Paraná, Argentina

Location

Investigational Site Number 8

Salta, Argentina

Location

Investigational Site Number 05

Sarandí, Argentina

Location

Investigational Site Number 20

Tandil, 7000, Argentina

Location

Investigational Site Number 25

Zárate, 2800, Argentina

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

AR (23)