Treatment of Latent Autoimmune Diabetes of the Adult

Diabetes Clinical Trial

— LADA  

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)?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140438
• Other study ID #: LADA
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: November 2018

Study information

• Verified date: January 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• metformin+ NPH insulin
Metformin 500 mg + 500 mg + 1000 mg NPH insulin , initially 0.20 U/kg body weight.
• metformin + sitagliptin +/- repaglinide
Metformin 500 mg + 500 mg + 1000 mg Sitagliptin 100 mg x 1 Repaglinide 1 mg x 3

Locations

Country	Name	City	State
Norway	Valdemar Grill	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Hals IK, Fiskvik Fleiner H, Reimers N, Astor MC, Filipsson K, Ma Z, Grill V, Björklund A. Investigating optimal ß-cell-preserving treatment in latent autoimmune diabetes in adults: Results from a 21-month randomized trial. Diabetes Obes Metab. 2019 Oct;21 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin secretion	insulin secretion measured by fasting and glucagon-stimulated C-peptide	2 years
Secondary	glycemic control	glycemic control (HbA1c)	2 years