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

Primary Purpose

Diabetes Mellitus Type 1

Status

Unknown status

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

NPH insulin

Glargine

Detemir

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring Basal insulin, long acting insulin analogs, metabolic control, HbA1c, C-peptide, IGF-I, GH, IGFBP

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Pediatrics, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Insulatard

Lantus

Levemir

Arm Description

Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars

Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Outcomes

Primary Outcome Measures

HbA1c

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

Sustacal stimulated C-peptide after an overnight fast

IGF-I

Serum IGF-I concentrations

Full Information

NCT ID

NCT01271517

First Posted

January 5, 2011

Last Updated

January 5, 2011

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01271517

Brief Title

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

Acronym

BAS

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

March 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 1

Keywords

Basal insulin, long acting insulin analogs, metabolic control, HbA1c, C-peptide, IGF-I, GH, IGFBP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulatard

Arm Type

Active Comparator

Arm Description

Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars

Arm Title

Lantus

Arm Type

Active Comparator

Arm Description

Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Arm Title

Levemir

Arm Type

Active Comparator

Arm Description

Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Intervention Type

Drug

Intervention Name(s)

NPH insulin

Intervention Description

Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar

Intervention Type

Drug

Intervention Name(s)

Glargine

Intervention Description

Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars

Intervention Type

Drug

Intervention Name(s)

Detemir

Intervention Description

Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars

Primary Outcome Measure Information:

Title

HbA1c

Description

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.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Stimulated C-peptide

Description

Sustacal stimulated C-peptide after an overnight fast

Time Frame

2 weeks and 3, 6 and 12 month

Title

IGF-I

Description

Serum IGF-I concentrations

Time Frame

diagnosis, 2 weeks, 3,6,9 and 12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Division of Pediatrics, Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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