This trial is active, not recruiting.

Condition diabetes
Treatments metformin+ nph insulin, metformin + sitagliptin +/- repaglinide
Sponsor Norwegian University of Science and Technology
Start date March 2009
End date March 2017
Trial size 78 participants
Trial identifier NCT01140438, LADA


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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.
metformin+ nph insulin Insulatard
Metformin 500 mg + 500 mg + 1000 mg NPH insulin , initially 0.20 U/kg body weight.
(Active Comparator)
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.
metformin + sitagliptin +/- repaglinide Novonorm
Metformin 500 mg + 500 mg + 1000 mg Sitagliptin 100 mg x 1 Repaglinide 1 mg x 3

Primary Outcomes

insulin secretion
time frame: 2 years

Secondary Outcomes

glycemic control
time frame: 2 years

Eligibility Criteria

Male or female participants from 30 years up to 75 years old.

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

Additional Information

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)?
Principal investigator Valdemar Grill, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.