Treatment of Latent Autoimmune Diabetes of the Adult

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)?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01140438

Acronym

LADA

Enrollment

Registered

2010-06-09

Start date

2009-03-31

Completion date

2018-11-30

Last updated

2020-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Latent autoimmune diabetes, adults, Beta cell rest, Insulin secretion

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.

Interventions

DRUGmetformin+ NPH insulin

Metformin 500 mg + 500 mg + 1000 mg NPH insulin , initially 0.20 U/kg body weight.

DRUGmetformin + sitagliptin +/- repaglinide

Metformin 500 mg + 500 mg + 1000 mg Sitagliptin 100 mg x 1 Repaglinide 1 mg x 3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
insulin secretion	2 years	insulin secretion measured by fasting and glucagon-stimulated C-peptide

Secondary

Measure	Time frame	Description
glycemic control	2 years	glycemic control (HbA1c)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026