Status:
UNKNOWN
Randomized Controlled Trial of Insulin Versus Tablets for Latent Autoimmune Diabetes in Adults (LADA)
Lead Sponsor:
Abertawe Bro Morgannwg University NHS Trust
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Latent Autoimmune Diabetes in Adults LADA
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Background: Latent autoimmune diabetes in adults \[LADA\] is a type 1 diabetes that is slowly developing. This means many people are treated as having type 2 diabetes at diagnosis as they are adults w...
Eligibility Criteria
Inclusion
- Male, non-fertile female (i.e., post menopausal, post hysterectomy, or sterilized by tubal ligation) or female of childbearing potential using a medically approved birth control method.
- The patient has a diagnosis of diabetes mellitus according to WHO classification.
- The patient has a positive GAD antibody test of 101 WHO units or more on two separate occasions.
- Age 18 +
- The patient did not start on insulin within 1 month of diagnosis
- Written informed consent to participate in the study.
- Ability to comply with all study requirements.
Exclusion
- Pregnant or breast-feeding females and females who plan pregnancy or breast-feeding during the course of the study.
- A history of:
- Diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- Acute infections, which may affect blood glucose control within 4 weeks prior to visit 1.
- Malignancy including leukaemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
- The patient has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
- The patient is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication that, in the opinion of the site investigator, might interfere with the study.
- Any of the following significant laboratory abnormalities:
- Patients with severe renal failure as defined previous renal transplant or currently having renal dialysis or GFR \<30.
- Clinically significant laboratory abnormalities, confirmed by repeat measurement, that may interfere with the assessment of safety and/or efficacy of the study drug, other than hyperglycemia and glycosuria at visit 1.
- Severe ketonuria (+++ on urine sticks testing; ++ on repeated urine sticks testing).
- The patient is a known or suspected drug abuser.
- The patient has chronic hepatitis or liver cirrhosis, or any other chronic liver disease.
- The patient is known to test positive for hepatitis B antigens or hepatitis C antibodies
- The patient is known to test positive for HIV antibodies.
- The patient has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the site investigator, are likely to affect the patient's response to treatment or their ability to complete the study.
- The patient has chronic haematological disease.
- The patient has had a severe blood loss (\>400 mL, e.g., blood donation) within 2 months before the first dosing of the study medication.
- The patient has known proliferative retinopathy.
- Patient has had stage 3-4 heart failure.
- The patient is participating in another research study which may affect the results of this trial.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00776607
Start Date
April 1 2007
End Date
April 1 2011
Last Update
October 21 2008
Active Locations (2)
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1
Diabetes Unit
Cardiff, Wales, United Kingdom, CF64 2XX
2
Clinical Research Unit
Swansea, Wales, United Kingdom, SA6 6NL