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Treatment of Latent Autoimmune Diabetes of the Adult (LADA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01140438
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : January 10, 2020
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: metformin+ NPH insulin Drug: metformin + sitagliptin +/- repaglinide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)?
Actual Study Start Date : March 2009
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Arm Intervention/treatment
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.
Drug: metformin+ NPH insulin
Metformin 500 mg + 500 mg + 1000 mg NPH insulin , initially 0.20 U/kg body weight.
Other Names:
  • Insulatard
  • Januvia

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

Primary Outcome Measures :
  1. insulin secretion [ Time Frame: 2 years ]
    insulin secretion measured by fasting and glucagon-stimulated C-peptide

Secondary Outcome Measures :
  1. glycemic control [ Time Frame: 2 years ]
    glycemic control (HbA1c)

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01140438

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Valdemar Grill
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
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Principal Investigator: Valdemar Grill, med phd Department of Cancer Research and Molecular Medicine
Publications of Results:
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Responsible Party: Norwegian University of Science and Technology Identifier: NCT01140438    
Other Study ID Numbers: LADA
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Latent autoimmune diabetes
Beta cell rest
Insulin secretion
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Sitagliptin Phosphate
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action