Treatment of Latent Autoimmune Diabetes of the Adult (LADA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Norwegian University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01140438
First received: June 8, 2010
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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 Intervention
Diabetes
Drug: metformin+ NPH insulin
Drug: metformin + sitagliptin +/- repaglinide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)?

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • insulin secretion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    insulin secretion measured by fasting and glucagon-stimulated C-peptide


Secondary Outcome Measures:
  • glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    glycemic control (HbA1c)


Estimated Enrollment: 78
Study Start Date: March 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140438

Contacts
Contact: Valdemar Grill, M.D. +47 72825188 valdemar.grill@ntnu.no
Contact: Hanne Fiskvik Fleiner, MPharm +47 90505101 hanne.f.fleiner@ntnu.no

Locations
Norway
Valdemar Grill Recruiting
Trondheim, Norway, 7006
Contact: Valdemar Grill, M.D.    47 72825188    valdemar.grill@ntnu.no   
Contact: Hanne Fiskvik Fleiner, MPharm    +47 90505101    hanne.f.fleiner@ntnu.no   
Principal Investigator: Valdemar Grill, M.D.         
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Valdemar Grill, M.D. Department of Cancer Research and Molecular Medicine
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01140438     History of Changes
Other Study ID Numbers: LADA
Study First Received: June 8, 2010
Last Updated: August 14, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Sweden: Regional Ethical Review Board

Keywords provided by Norwegian University of Science and Technology:
Latent autoimmune diabetes
adults
Beta cell rest
Insulin secretion

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Isophane insulin, beef
Metformin
Repaglinide
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014