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

National, Phase IV, Multicentric, Open Label, Comparative Study to Evaluate the Efficacy and Safety of Insulin Glargine Plus Glulisine and Sliding Scale Plus Glulisine in Hospitalized Patients With Diabetes Metabolism Type II Under Enteral Nutrition.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01081938

Enrollment

Registered

2010-03-05

Start date

2010-02-28

Completion date

2011-02-28

Last updated

2012-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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

Interventions

DRUGINSULIN GLARGINE

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

DRUGINSULIN GLULISINE

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Glycaemic parameters assessment	During the period of 7 Days of treatment

Secondary

Measure	Time frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026