Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition
This study has been terminated.
(Recruitment challenges)
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01081938
First received: March 4, 2010
Last updated: March 26, 2012
Last verified: March 2012
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Purpose
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:
- Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period.
- Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period.
- Incidence of severe hyperglycemia (>400mg/dL) during the treatment period.
- Total dose of insulin and correction dose in each group.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: INSULIN GLARGINE Drug: INSULIN GLULISINE |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Glycaemic parameters assessment [ Time Frame: During the period of 7 Days of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of moderate and severe hyperglycemia [ Time Frame: During the period of 7 Days of treatment ] [ Designated as safety issue: No ]
- Incidence of symptomatic, nocturnal and severe hypoglycemias [ Time Frame: During the period of 7 Days of treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | February 2010 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Insulin Glargine + Insulin Glulisine
|
Drug: INSULIN 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 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 |
|
Active Comparator: 2
Insulin Glulisine
|
Drug: INSULIN 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081938
Locations
| Brazil | |
| Sanofi-Aventis Investigational Site Number 076-007 | |
| Belo Horizonte, Brazil, 30150-120 | |
| Sanofi-Aventis Investigational Site Number 076-011 | |
| Curitiba, Brazil, 80420-011 | |
| Sanofi-Aventis Investigational Site Number 076-005 | |
| Joinville, Brazil | |
| Sanofi-Aventis Investigational Site Number 076-001 | |
| Porto Alegre, Brazil, 90035-001 | |
| Sanofi-Aventis Investigational Site Number 076-004 | |
| Porto Alegre, Brazil, 90035-003 | |
| Sanofi-Aventis Investigational Site Number 076-006 | |
| São José do Rio Preto, Brazil, 15090-000 | |
| Sanofi-Aventis Investigational Site Number 076-009 | |
| São Paulo, Brazil, 01323-900 | |
| Sanofi-Aventis Investigational Site Number 076-008 | |
| São Paulo, Brazil, 01308-050 | |
| Sanofi-Aventis Investigational Site Number 076-003 | |
| São Paulo, Brazil, 01323-020 | |
| Sanofi-Aventis Investigational Site Number 076-010 | |
| São Paulo, Brazil, 01232-010 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01081938 History of Changes |
| Other Study ID Numbers: | LANTU_L_04572, U1111-1116-9777 |
| Study First Received: | March 4, 2010 |
| Last Updated: | March 26, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine |
Insulin glulisine Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013