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

January 5, 2011 updated by: Karolinska Institutet

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Division of Pediatrics, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stimulated C-peptide
Time Frame: 2 weeks and 3, 6 and 12 month
Sustacal stimulated C-peptide after an overnight fast
2 weeks and 3, 6 and 12 month
IGF-I
Time Frame: diagnosis, 2 weeks, 3,6,9 and 12 month
Serum IGF-I concentrations
diagnosis, 2 weeks, 3,6,9 and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 5, 2011

First Posted (Estimate)

January 6, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2011

Last Update Submitted That Met QC Criteria

January 5, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eudract-number 2005-001726-80

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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