Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition

NCT01081938 | Terminated Phase 4

• 2 other identifiers: LANTU_L_04572U1111-1116-9777
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 10

Brief Summary

Primary Objective: 1- Proportion of patients with mean daily glycemia \<140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale. Secondary Objective:

1. 1.Incidence of moderate hyperglycemia (\>140mg/dL) during the treatment period.
2. 2.Incidence of hypoglycemia (\<60mg/dL and \< 40mg/dL) during the treatment period.
3. 3.Incidence of severe hyperglycemia (\>400mg/dL) during the treatment period.
4. 4.Total dose of insulin and correction dose in each group.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycaemic parameters assessment

  During the period of 7 Days of treatment

Secondary Outcomes (2)

• Incidence of moderate and severe hyperglycemia

  During the period of 7 Days of treatment

• Incidence of symptomatic, nocturnal and severe hypoglycemias

  During the period of 7 Days of treatment

Study Arms (2)

1

EXPERIMENTAL

Insulin Glargine + Insulin Glulisine

Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

2

ACTIVE COMPARATOR

Insulin Glulisine

Drug: INSULIN GLULISINE

Interventions

INSULIN GLARGINE DRUG

Pharmaceutical form: Lantus® (100 U/ml) Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device. Dose regimen: Single daily dose of Insulin Glargine

1

INSULIN GLULISINE DRUG

Pharmaceutical form: Apidra® (100 U/ml) Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device Dose regimen: Arm1: Every 6 hours Arm2: several daily dose according to sliding scale of Insulin Glargine

1; 2

Eligibility Criteria

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

You may qualify if:

• Men and women with type 2 diabetes that will need enteral nutrition with carbohydrate content.
• Glycemia \>140mg/dL and \< 400mg/dL at admission on the ward.
• Informed consent (patient or legally authorized representative)

You may not qualify if:

• Hypersensibility to insulin glargine or glulisine, or any other component of the insulin formulation.
• Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
• History of diabetic ketoacidosis or hyperosmolar hyperglycaemic state or ketonuria.
• Subjects with conditions that are expected to need surgery or intensive care unit (ICU)admission based on discussions with the treatment team and attending physician.
• Pregnancy.
• Severe hepatic disease or active hepatitis.
• Cardiac failure class III or IV (Classification de la New York Heart Association:NYHA).
• Diagnosed advanced autonomic neuropathy.
• Diagnosed cancer.
• Active infection.
• Current therapy with steroids.
• Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
• 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 (10)

Sanofi-Aventis Investigational Site Number 076-007

Belo Horizonte, 30150-120, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-011

Curitiba, 80420-011, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-005

Joinville, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-001

Porto Alegre, 90035-001, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-004

Porto Alegre, 90035-003, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-006

São José do Rio Preto, 15090-000, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-010

São Paulo, 01232-010, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-008

São Paulo, 01308-050, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-003

São Paulo, 01323-020, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-009

São Paulo, 01323-900, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; insulin glulisine

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

BR (10)