Latent Autoimmune Diabetes in Adults LADALITNCT00776607
Randomized Controlled Trial of Insulin Versus Tablets for Latent Autoimmune Diabetes in Adults (LADA)
A study testing NovoMix 30 and Tablet treatment in people with Latent Autoimmune Diabetes in Adults LADA, run by Abertawe Bro Morgannwg University NHS Trust at 2 sites in United Kingdom.
Trial 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 who are not immediately insulin dependent. LADA can be distinguished from type 2 diabetes by antibody tests. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Latent Autoimmune Diabetes in Adults LADA
- What is being tested?
- NovoMix 30 and Tablet treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2007to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Diabetes Unit
Cardiff, Wales, CF64 2XX
Julia Platts, 02920 711 711 ext. 5149, Julia.Platts@CardiffandVale.wales.nhs.uk
Julia Platts
- Recruiting
Clinical Research Unit
Swansea, Wales, SA6 6NL
Lucy Barlow, +44 (0) 1792 703722 ext. 3722, Lucy.Barlow@swansea-tr.wales.nhs.uk
Jeffrey Stephens
About this study
Official title: Randomized, Controlled, Parallel-Group Prospective Study to Investigate the Clinical Effectiveness of Early Insulin Treatment in Patients With Latent Autoimmune Diabetes in Adults
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 who are not immediately insulin dependent. LADA can be distinguished from type 2 diabetes by antibody tests. Patients who are antibody positive have an autoimmune reaction which is similar to that of type 1 diabetes and is not found in type 2 diabetes. We would like to examine the best way of treating LADA in the early phase of the conditions, with tablets (similar to type 2 diabetes) or with insulin (similar to type 1 diabetes).
Methods/Design: This is an open parallel group prospective randomised trial. Participants need to have a GAD antibody test results of 101 WHO units or more and a diagnosis of diabetes not requiring insulin at diagnosis. Participants will need to have been diagnosed within 12 months and not treated with insulin at study entry. They will be randomised to receive either insulin (NovoMix 30) or tablets (diet treated followed by metformin followed by glitazone (with or without metformin) followed by insulin). Primary outcome assessment will be for change in HbA1c and change in fasting C-peptide over 24 months. Secondary outcome measures will include Quality of life, GAD antibody levels, adverse events, inflammatory markers, insulin resistance, and markers of the metabolic syndrome.
Discussion: This study seeks the best treatment for early LADA in terms of maintaining glycaemic control and maintaining natural insulin production.
- Being tested
- NovoMix 30, Tablet treatment
- Keywords
- LADA, Latent autoimmune diabetes in adults, Type 1.5, Slowly progressive type 1 diabetes
- Medical subject headings
- Latent Autoimmune Diabetes in Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoMix 30Drug
Insulin arm: Patients will be given advice on diet and exercise and life style and will be started on NovoMix 30, one dose of 6 U at the evening/main meal. Dose will be adjusted in increments of 2-6U depending on fasting glucose level When total dose equals 16 U patient will be started on 4 units with breakfast and continue with 16 units with evening meal. Breakfast and/or evening meal dose will be adjusted where necessary at increments of 2-6 U depending on fasting and/or pre-evening meal glucose level. Patient needs to keep a daily diary of insulin doses taken.
Tablet treatmentDrug
Step 1: Lifestyle modification. If HbA1c at 7%+ or if on metformin/sulphonylurea go to step 2. Step 2: Glucophage. If HbA1c of 7%-7.5% give 500mg x 1 per day. If HbA1c 7.6%-8.0%, week 1 - 500mg x 1 day and then 500mg x 2 day. If HbA1c 8.0%+ then 500mg x 3 per day (Titrated). If HbA1c remains 7%+ give additional tablet until 2gms per day then progress to Step 3. Step 3: Rosiglitazone. HbA1c of 7%+ give 4 mg per day. If HbA1c remains 7%+ titrate to maximal dose 4 mg twice daily +/-Metformin. If HbA1c remains 7% + for an 3 months move to step 4. Before initiation of Rosiglitazone repeat medical history with special emphasis on cardiovascular disease, if patient has a history of CVD move to Step 4 (insulin). Any adverse events suggestive of heart disease move to step 4. Step 4: Insulin (oral agents will be stopped). Initiation of insulin will the same as for the insulin arm and will follow the protocol detailed in the Insulin arm.
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Experimental | Insulin: NovoMix 30. Patients will be given advice on diet and exercise and life style and will be started on NovoMix 30, one dose of 6 U at the evening/main meal. Receives: Drug: NovoMix 30 |
| Tablet | Active comparator | Patients will progress from lifestyle modification to metformin, to metformin with Rosiglitazone and finally insulin depending on HbA1c levels. Receives: Drug: Tablet treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting serum C-peptide level over 24 months and (2) change in HbA1c level over 24 months in patients with LADA.
Measured: 24 months
Secondary outcomes (1)
Hypoglycaemic events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent Autoimmune Diabetes in Adults LADAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abertawe Bro Morgannwg University NHS Trust
- Sponsor type
- Other government
- Collaborators
- Novo Nordisk A/S
- Investigators
- Sinead Brophy, Principal investigator, Swansea UniversityStephen Bain, Study director, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776607
- Sponsor's protocol ID
- 2006-004662-14
- Other IDs
- ISRCTN63815121, 07/MRE09/8
- Acronym
- LIT
- Status last verified
- Sep 2008
- First submitted
- 20 Oct 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brophy S, Davies H, Bain S, Stephens JW, Cheung WY, Richards K, Wareham K, Beaverstock C, Lloyd J, Page D, Williams M, Russell I, Williams R. Randomized, controlled, parallel-group prospective study to investigate the clinical effectiveness of early insulin treatment in patients with latent autoimmune diabetes in adults. BMC Endocr Disord. 2008 Jul 24;8:8. doi: 10.1186/1472-6823-8-8.
PubMed 18652676
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Parallel-Group Prospective Study to Investigate the Clinical Effectiveness of Early Insulin Treatment in Patients With Latent Autoimmune Diabetes in Adults
- ClinicalTrials.gov ID
- NCT00776607
- Acronym / sponsor ID
- LIT / 2006-004662-14
- Keywords
- LADA, Latent autoimmune diabetes in adults, Type 1.5, Slowly progressive type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abertawe Bro Morgannwg University NHS TrustOther government
- Collaborators
- Novo Nordisk A/S
- Study start
- Apr 2007
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 who are not immediately insulin dependent. LADA can be distinguished from type 2 diabetes by antibody tests. Patients who are antibody positive have an autoimmune reaction which is similar to that of type 1 diabetes and is not found in type 2 diabetes. We would like to examine the best way of treating LADA in the early phase of the conditions, with tablets (similar to type 2 diabetes) or with insulin (similar to type 1 diabetes).
Methods/Design: This is an open parallel group prospective randomised trial. Participants need to have a GAD antibody test results of 101 WHO units or more and a diagnosis of diabetes not requiring insulin at diagnosis. Participants will need to have been diagnosed within 12 months and not treated with insulin at study entry. They will be randomised to receive either insulin (NovoMix 30) or tablets (diet treated followed by metformin followed by glitazone (with or without metformin) followed by insulin). Primary outcome assessment will be for change in HbA1c and change in fasting C-peptide over 24 months. Secondary outcome measures will include Quality of life, GAD antibody levels, adverse events, inflammatory markers, insulin resistance, and markers of the metabolic syndrome.
Discussion: This study seeks the best treatment for early LADA in terms of maintaining glycaemic control and maintaining natural insulin production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | Experimental | Drug: NovoMix 30Insulin: NovoMix 30. Patients will be given advice on diet and exercise and life style and will be started on NovoMix 30, one dose of 6 U at the evening/main meal. |
| Tablet | Active comparator | Drug: Tablet treatmentPatients will progress from lifestyle modification to metformin, to metformin with Rosiglitazone and finally insulin depending on HbA1c levels. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoMix 30Insulin arm: Patients will be given advice on diet and exercise and life style and will be started on NovoMix 30, one dose of 6 U at the evening/main meal. Dose will be adjusted in increments of 2-6U depending on fasting glucose level When total dose equals 16 U patient will be started on 4 units with breakfast and continue with 16 units with evening meal. Breakfast and/or evening meal dose will be adjusted where necessary at increments of 2-6 U depending on fasting and/or pre-evening meal glucose level. Patient needs to keep a daily diary of insulin doses taken. | Drug | Insulin |
| Tablet treatmentStep 1: Lifestyle modification. If HbA1c at 7%+ or if on metformin/sulphonylurea go to step 2. Step 2: Glucophage. If HbA1c of 7%-7.5% give 500mg x 1 per day. If HbA1c 7.6%-8.0%, week 1 - 500mg x 1 day and then 500mg x 2 day. If HbA1c 8.0%+ then 500mg x 3 per day (Titrated). If HbA1c remains 7%+ give additional tablet until 2gms per day then progress to Step 3. Step 3: Rosiglitazone. HbA1c of 7%+ give 4 mg per day. If HbA1c remains 7%+ titrate to maximal dose 4 mg twice daily +/-Metformin. If HbA1c remains 7% + for an 3 months move to step 4. Before initiation of Rosiglitazone repeat medical history with special emphasis on cardiovascular disease, if patient has a history of CVD move to Step 4 (insulin). Any adverse events suggestive of heart disease move to step 4. Step 4: Insulin (oral agents will be stopped). Initiation of insulin will the same as for the insulin arm and will follow the protocol detailed in the Insulin arm. | Drug | Tablet |
Primary outcome
Change in fasting serum C-peptide level over 24 months and (2) change in HbA1c level over 24 months in patients with LADA.
Time frame: 24 months
1 secondary outcome
Hypoglycaemic events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
- Background: PubMed 18652676Brophy S, Davies H, Bain S, Stephens JW, Cheung WY, Richards K, Wareham K, Beaverstock C, Lloyd J, Page D, Williams M, Russell I, Williams R. Randomized, controlled, parallel-group prospective study to investigate the clinical effectiveness of early insulin treatment in patients with latent autoimmune diabetes in adults. BMC Endocr Disord. 2008 Jul 24;8:8. doi: 10.1186/1472-6823-8-8.
Related trials for Latent Autoimmune Diabetes in Adults LADA
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
Recruiting
Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes
Type 1 Diabetes (T1D), Latent Autoimmune Diabetes in Adult (LADA)
Not yet recruiting
Effects of Cofrogliptin on Beta-Cell Function in LADA Patients
Latent Autoimmune Diabetes in Adults (LADA)
RecruitingObservational study
Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults
Type 1 Diabetes Mellitus, Latent Autoimmune Diabetes in Adult (LADA)
Not yet recruitingObservational study
Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes
Type 1 Diabetes, Liver Steatoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sinead Brophy principal investigator
Swansea University
Stephen Bain study director
Swansea University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovoMix 30 and Tablet treatment in people with Latent Autoimmune Diabetes in Adults LADA, run by Abertawe Bro Morgannwg University NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sinead Brophy (00 44 1792 602058 ext. 2058, s.brophy@swansea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting serum C-peptide level over 24 months and (2) change in HbA1c level over 24 months in patients with LADA. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00776607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.