NCT01140438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

9.7 years

First QC Date

June 8, 2010

Last Update Submit

January 8, 2020

Conditions

Diabetes

Keywords

Latent autoimmune diabetesadultsBeta cell restInsulin secretion

Outcome Measures

Primary Outcomes (1)

  • insulin secretion

    insulin secretion measured by fasting and glucagon-stimulated C-peptide

    2 years

Secondary Outcomes (1)

  • glycemic control

    2 years

Study Arms (2)

Metformin + NPH Insulin

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.

Drug: metformin+ NPH insulin

Metformin + sitagliptin +/-repaglinid

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.

Drug: metformin + sitagliptin +/- repaglinide

Interventions

metformin+ NPH insulinDRUG

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

Also known as: Insulatard, Januvia
Metformin + NPH Insulin
metformin + sitagliptin +/- repaglinideDRUG

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

Also known as: Novonorm
Metformin + sitagliptin +/-repaglinid

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valdemar Grill

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Hals IK, Fiskvik Fleiner H, Reimers N, Astor MC, Filipsson K, Ma Z, Grill V, Bjorklund A. Investigating optimal beta-cell-preserving treatment in latent autoimmune diabetes in adults: Results from a 21-month randomized trial. Diabetes Obes Metab. 2019 Oct;21(10):2219-2227. doi: 10.1111/dom.13797. Epub 2019 Jun 19.

    PMID: 31148332RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Isophane Insulin, HumanSitagliptin PhosphateMetforminrepaglinide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, IsophaneInsulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsInsulin, Regular, HumanInsulinProinsulinPeptidesAmino Acids, Peptides, and ProteinsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Valdemar Grill, med phd

    Department of Cancer Research and Molecular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 9, 2010

Study Start

March 1, 2009

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

NO(1)