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

NCT01271517 | Unknown Phase 4

• 1 other identifier: Eudract-number 2005-001726-80
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Stimulated C-peptide

  2 weeks and 3, 6 and 12 month

• IGF-I

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

Study Arms (3)

Insulatard

ACTIVE COMPARATOR

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

Drug: NPH insulin

Lantus

ACTIVE COMPARATOR

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

Drug: Glargine

Levemir

ACTIVE COMPARATOR

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

Drug: Detemir

Interventions

NPH insulin DRUG

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

Insulatard

Glargine DRUG

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

Lantus

Detemir DRUG

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

Levemir

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Division of Pediatrics, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin, Isophane; Insulin Glargine; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: September 1, 2005
• Primary Completion: March 1, 2011
• Last Updated: January 6, 2011

Record last verified: 2011-01

Locations

SE (1)