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Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis (BAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Karolinska Institutet.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01271517
First received: January 5, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis.

This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart). The investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.


Condition Intervention Phase
Diabetes Mellitus Type 1
 Drug: NPH insulin
Drug: Glargine
Drug: Detemir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of New Longacting Insulin Analogs on Metabolic Control, Endogenous Insulin Production, GH/IGF-I Axis and Quality of Life - Comparison of NPH, Glargine Och Detemir Insulin From the Debut of Type 1 Diabetes Mellitus in Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The study compare HbA1c one year after start of treatment at diagnosis of T1DM in patients treated with Lantus or Levemir with patients treated with Insulatard.


Secondary Outcome Measures:
  • Stimulated C-peptide [ Time Frame: 2 weeks and 3, 6 and 12 month ] [ Designated as safety issue: No ]
    Sustacal stimulated C-peptide after an overnight fast

  • IGF-I [ Time Frame: diagnosis, 2 weeks, 3,6,9 and 12 month ] [ Designated as safety issue: No ]
    Serum IGF-I concentrations


Enrollment: 120
Study Start Date: September 2005
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulatard
Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars
 Drug: NPH insulin
Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar
Active Comparator: Lantus
Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
 Drug: Glargine
Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars
Active Comparator: Levemir
Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
 Drug: Detemir
Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of diabetes and novel to insulin therapy
  • Age 7 - 17 years
  • Informed consent

Exclusion Criteria:

  • Moderate to severe ketoacidosis (pH<7.2 and/or standard bicarbonate <10 mmol/l)
  • Suspected non-type 1
  • IA2 and GAD65: all-antibody negative
  • Celiac disease or other chronic disease
  • Hypothyroidism, if not well controlled
  • Syndromes
  • Previous anorexia nervosa
  • Neuro-psychiatric disease
  • Malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271517

Locations
Sweden
Division of Pediatrics, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Peter Bang, MD, PhD, Associated Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01271517     History of Changes
Other Study ID Numbers: Eudract-number 2005-001726-80
Study First Received: January 5, 2011
Last Updated: January 5, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
Basal insulin
long acting insulin analogs
metabolic control
HbA1c
 C-peptide
IGF-I
GH
IGFBP

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013