6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00993473

Purpose

The primary study objective is to compare the rate of "all hypoglycemia" between children treated with insulin glargine and Neutral Protamine Hagedorn (NPH) insulin.

Secondary objectives are to compare insulin glargine and NPH in terms of:

rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia
HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment
percentage of patients reaching HbA1 less than 7.5% (target value) at end-of-treatment
average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM)

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: INSULIN GLARGINE (HOE901) Drug: Neutral Protamine Hagedorn (NPH) insulin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 24-week, Randomized, Open-label, Parallel Group Multinational Comparison of Lantus® (Insulin Glargine) Given in the Morning as Once-a-day Basal Insulin Versus NPH Insulin, in Children With Type 1 Diabetes Mellitus Aged at Least 1 Year to Less Than 6 Years

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin Insulin beef Insulin glargine Protamine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Event rate of "all hypoglycemia" during treatment with study drugs, which consists of: CGM glucose <70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values <70 mg/dL (3.9mM), symptomatic hypoglycemia episodes [ Time Frame: Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rates of symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
HbA1c change from baseline to end-of-treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
HbA1c at end of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Percentage of patients reaching HbA1c target of less than 7.5% at the end-of-treatment visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Average daily blood glucose (BG) based on CGM (both the end-of-treatment value and the change from baseline to end of treatment) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	125
Study Start Date:	October 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lantus Lantus given as basal insulin once a day in the morning by subcutaneous injection	Drug: INSULIN GLARGINE (HOE901) Pharmaceutical form:injection Route of administration: subcutaneous
Active Comparator: NPH Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection	Drug: Neutral Protamine Hagedorn (NPH) insulin Pharmaceutical form:injection Route of administration: subcutaneous

Detailed Description:

Screening phase: 2 to 4 weeks

Treatment phase: 24 weeks

Follow-up phase: 2 weeks

All Phases: 28 to 30 weeks

Eligibility

Ages Eligible for Study:	1 Year to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study

Exclusion criteria:

Diagnosis of type 1 diabetes for less than one year
HbA1c at screening >12% or <6%
Diabetes other than type 1 diabetes
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
Patients treated with insulin pump therapy during the two months prior to screening
History of primary seizure disorder
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
Serum creatinine > 2.0mg/dL at screening
Serum ALT or AST greater than 3x upper limit of normal for the patient's age and gender, at screening
Hemoglobin < 10g/dL, or platelet count less than 100,000/cu mm, at screening
Treatment with any pharmacologic anti-hyperglycemic oral agent for more than 3 months at any time
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin®) for the 3 months prior to screening
Treatment with systemic glucocorticoids within the month prior to screening

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: NCT00993473

Show 71 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00993473 History of Changes
Other Study ID Numbers:	EFC11202
Study First Received:	October 9, 2009
Last Updated:	September 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glargine
Insulin
Insulin, NPH

Insulin, Long-Acting
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012