Treatment of Latent Autoimmune Diabetes of the Adult (LADA)
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Purpose
The purpose of the study is to clarify whether patients classified as Latent autoimmune diabetes of the adult (LADA) benefit from early treatment with insulin added to per oral treatment and lifestyle measures.
| Condition | Intervention |
|---|---|
|
Diabetes |
Drug: metformin+ NPH insulin Drug: metformin + sitagliptin +/- repaglinide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Is "Beta Cell Rest" by Insulin Treatment Beneficial Compared to State-of-the Art Enhancers of Insulin Secretion in Preserving Beta Cell Function in Subjects With Latent Autoimmune Diabetes of the Adult (LADA)? |
- insulin secretion [ Time Frame: 2 years ] [ Designated as safety issue: No ]insulin secretion measured by fasting and glucagon-stimulated C-peptide
- glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]glycemic control (HbA1c)
| Estimated Enrollment: | 78 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Metformin + NPH Insulin
Patients are treated with metformin during the run-in period (3 months) and also after randomization. By randomization insulin treatment will be added in the form of injections of NPH insulin in the evenings.
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Drug: metformin+ NPH insulin
Metformin 500 mg + 500 mg + 1000 mg NPH insulin , initially 0.20 U/kg body weight.
Other Names:
|
|
Active Comparator: Metformin + sitagliptin +/-repaglinid
Patients are treated with metformin during the run-in period (3 months) and also after randomization. By randomization sitagliptin tablets will be added.If HbA1c after 6 months of treatment is > 10 % above the upper limit of normal,then treatment with repaglinide tablets tree times daily at mealtimes will be added.
|
Drug: metformin + sitagliptin +/- repaglinide
Metformin 500 mg + 500 mg + 1000 mg Sitagliptin 100 mg x 1 Repaglinide 1 mg x 3
Other Name: Novonorm
|
Detailed Description:
Latent autoimmune diabetes of the adult (LADA) is usually defined as a form of diabetes where the onset of diabetes takes place approximately after 30 years of age, where there is presence of beta-cell directed antibodies (mostly anti-GAD) and where there is no clinical need for insulin treatment during the first 6 months after the diagnosis of diabetes.
The aetiology and treatment of LADA patients is much less elucidated than is the case for type 1 diabetes (DM1) and type 2 diabetes (DM2). LADA constitutes about 10 % of the total diabetic population in many countries. LADA is therefore more common than insulin-requiring DM1.
LADA patients lose beta-cell function faster than patients with DM2. Residual beta-cell function in DM1 is coupled to better metabolic control with lesser degree of hyperglycemia, lesser frequency of hypoglycaemic events and lesser diabetic complications.
To retain beta-cell function in LADA patients is thus highly desirable.
There are several strategies to retain beta cell function. One therapeutic strategy is to induce some degree of "beta cell rest" by treatment with exogenous insulin. Several observations indicate that such a strategy can have beneficial effects.
This is a Scandinavian multicenter non-blinded clinical trial with 78 participants with newly diagnosed LADA. Participants will be randomized to either insulin- or per oral antidiabetic treatment. Participants will be followed up for 2 years after inclusion. Beta cell function and glycemic control will be monitored.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diabetes diagnosed during 0-3 years before entering the study.
- Age > or equal to 30 years < or equal to 75 years
- anti-GAD positivity
- fasting C-peptide > or equal to 0,3 ng/ml
- no need for insulin treatment by clinical judgement for at least 3 months following the diagnosis of diabetes.
- HbA1c > 15 % above the upper limit of normal
Exclusion Criteria:
- Renal insufficiency (plasma creatinine > 150 mol/L)
- Severe retinopathy (proliferative or pre-proliferative)
- Severe cardiac disease (NYHA III-IV)
- Chronic severe illness judged by the investigator
- Females of reproductive age who wish to become pregnant during the study
Contacts and Locations| Contact: Valdemar Grill, M.D. | +47 72825188 | valdemar.grill@ntnu.no |
| Contact: Hanne Fiskvik Fleiner, MPharm | +47 90505101 | hanne.f.fleiner@ntnu.no |
| Norway | |
| Valdemar Grill | Recruiting |
| Trondheim, Norway, 7006 | |
| Contact: Valdemar Grill, M.D. 47 72825188 valdemar.grill@ntnu.no | |
| Contact: Hanne Fiskvik Fleiner, MPharm +47 90505101 hanne.f.fleiner@ntnu.no | |
| Principal Investigator: Valdemar Grill, M.D. | |
| Principal Investigator: | Valdemar Grill, M.D. | Department of Cancer Research and Molecular Medicine |
More Information
No publications provided
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01140438 History of Changes |
| Other Study ID Numbers: | LADA |
| Study First Received: | June 8, 2010 |
| Last Updated: | March 29, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Sweden: Regional Ethical Review Board |
Keywords provided by Norwegian University of Science and Technology:
|
Latent autoimmune diabetes adults Beta cell rest Insulin secretion |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Repaglinide Sitagliptin Insulin |
Insulin, NPH Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013