ClinicalTrials.Veeva

Menu

Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

L

Lund University Hospital

Status and phase

Completed
Phase 4

Conditions

Diabetes Mellitus, Adult-Onset
Diabetes, Autoimmune

Treatments

Drug: Insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT01109927
LundUH-LADA101

Details and patient eligibility

About

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.

Full description

All adult newly diagnosed diabetic patients in the certain areas are screened for pancreatic antibodies. Patients clinically classified as Type 2, not insulin requiring at diagnosis and positive for at least one autoantibody are eligible for inclusion. After randomisation to insulin treatment or diet and/or OHA, the patients are followed up with fasting C-peptide every third month. A glucagon test is performed, and stimulated C-peptide and HbA1c, + clinical data and body weight are recorded at baseline and after 12, 24 and 36 months. The final outcome of the study is C-peptide, and change in C-peptide compared to baseline level, and HbA1c, after 36 months.

Enrollment

42 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • >18 yrs
  • Positive for pancreatic autoantibodies

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Insulin treatment
Experimental group
Description:
Insulin given as soon as possible after diagnosis
Treatment:
Drug: Insulin
Conventional treatment
No Intervention group
Description:
Diet, oral hypoglycemic agents and insulin first when clinically needed
Treatment:
Drug: Insulin

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems