Clinical trial NCT01140438: Treatment of Latent Autoimmune Diabetes of the Adult
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)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Latent autoimmune diabetes
adults
Beta cell rest
Insulin secretion
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: insulin secretion
timeFrame: 2 years
Secondary outcomes:
measure: glycemic control
timeFrame: 2 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Valdemar Grill
Study officials:
affiliation: Department of Cancer Research and Molecular Medicine
name: Valdemar Grill, med phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hals IK, Fiskvik Fleiner H, Reimers N, Astor MC, Filipsson K, Ma Z, Grill V, Bjorklund A. Investigating optimal beta-cell-preserving treatment in latent autoimmune diabetes in adults: Results from a 21-month randomized trial. Diabetes Obes Metab. 2019 Oct;21(10):2219-2227. doi: 10.1111/dom.13797. Epub 2019 Jun 19.