Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

NCT01109927 | Completed Phase 4

• 1 other identifier: LundUH-LADA101
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Among adult patients diagnosed with type 2 diabetes, about 6% have autoantibodies directed against the insulin producing beta cells in the pancreas. These patients have a progressive beta cell destruction and most of them will be insulin dependent within 3-5 yrs. Patients with this latent autoimmune diabetes in adults (LADA) have a considerable remaining beta cell mass at diagnosis, and are suitable for evaluating new therapies for autoimmune diabetes Animal studies in diabetes prone mice have demonstrated potential positive effects of early insulin treatment, with a lower incidence of diabetes or a delay before diagnosis. The aim of this study was to investigate the effect of early insulin treatment of LADA patients, in respect to residual beta-cell function and metabolic control, compared to a group who were conventionally treated with diet and/or oral hypoglycaemic agents (OHA) and insulin not before it was clinically needed.

Conditions

Diabetes, Autoimmune; Diabetes Mellitus, Adult-Onset

Outcome Measures

Primary Outcomes (1)

• Glucagon stimulated C-peptide

  Glucagon stimulated C-peptide is measured at diagnosis and annually for three years. Basal values will be compared to values obtained after 36 months.

  36 months after entering the study

Study Arms (2)

Insulin treatment

EXPERIMENTAL

Insulin given as soon as possible after diagnosis

Drug: Insulin

Conventional treatment

NO INTERVENTION

Diet, oral hypoglycemic agents and insulin first when clinically needed

Drug: Insulin

Interventions

Insulin DRUG

Insulin treatment in accordance to glucose values

Conventional treatment; Insulin treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 yrs
• Positive for pancreatic autoantibodies

You may not qualify if:

• \<18 yrs
• Significant concomitant diseases
• Not able to follow protocol

Sponsors & Collaborators

• Lund University Hospital: lead
• Landstinget Kronoberg, Sweden: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Insulin

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)

Proinsulin; 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: April 8, 2010
• First Posted: April 23, 2010
• Study Start: February 1, 1995
• Primary Completion: April 1, 2002
• Study Completion: May 1, 2005
• Last Updated: April 23, 2010

Record last verified: 1995-02