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

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Sanofi

Status and phase

Terminated
Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: INSULIN GLARGINE
Drug: INSULIN GLULISINE

Study type

Interventional

Funder types

Industry

Identifiers

NCT01081938
LANTU_L_04572
U1111-1116-9777 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

1
Experimental group
Description:
Insulin Glargine + Insulin Glulisine
Treatment:
Drug: INSULIN GLULISINE
Drug: INSULIN GLARGINE
2
Active Comparator group
Description:
Insulin Glulisine
Treatment:
Drug: INSULIN GLULISINE

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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