NCT02105792

Brief Summary

This study will examine extreme responders to second- and third-line Type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
820

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

5 active sites

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, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

2.2 years

First QC Date

April 2, 2014

Last Update Submit

June 19, 2018

Conditions

Diabetes

Keywords

DiabetesType 2 diabetesDiabetes therapy responseDiabetes progression

Outcome Measures

Primary Outcomes (1)

  • Response to diabetes therapy

    The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or a poor response to specific second- and third-line classes of treatment for Type 2 diabetes.

    Up to 9 months from commencement of new therapy

Secondary Outcomes (1)

  • Collection of samples for analysis of potential biomarkers

    within 9 months of recruitment date

Study Arms (2)

Responders

Patients with Type 2 diabetes about to commence a second- or third-line glucose-lowering treatment (Sulphonylurea, DPP-4 inhibitors, GLP-1R agonists, SGLT2 inhibitors or Glitazone or insulin).

Drug: second- or third-line glucose-lowering diabetes treatment

Progressors

Patients with Type 2 diabetes that progress to requiring insulin treatment ≤10 years from diagnosis or have no requirement for insulin treatment \>10 years from diagnosis.

Interventions

second- or third-line glucose-lowering diabetes treatmentDRUG

Observation of response and disease progression following clinician's addition of a glucose-lowering diabetes therapy (Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone) to existing therapy.

Also known as: Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor, Glitazone
Responders

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be identified in primary care and secondary care. The method for patient identification may differ between sites and could involve: GP Searches; Secondary Care Clinician Referral; Research Database Searches.

You may qualify if:

  • Demographics: Age 18-90 inclusive
  • Ethnicity: Reflective of local demographic
  • Medical History: Clinical diagnosis of Type 2 diabetes
  • Mental Capacity: Capacity to Consent

You may not qualify if:

  • Age less than 18 years old and greater than 90 years old
  • Incapacity to consent
  • Type 1 diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Exeter

Exeter, Devon, EX2 5DW, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

University of Newcastle

Newcastle upon Tyne, Tyne and Wear, NE1 7RU, United Kingdom

Location

University of Glasgow

Glasgow, G12 8TA, United Kingdom

Location

King's College University of London

London, SE1 9NH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

At Visit 1, a fasting blood sample (approximately 35 ml) will be collected for DNA extraction, and to measure for markers of the progression of diabetes or response to diabetes medication and for secondary markers that may predict response. A urine sample is also collected to measure for biomarkers. At Visit 2 a fasting blood sample and urine sample will be collected to measure for markers of the response to diabetes medication and for secondary markers that may predict response.

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Sulfonylurea CompoundsDipeptidyl-Peptidase IV InhibitorsSodium-Glucose Transporter 2 InhibitorsThiazolidinediones

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic ChemicalsSulfonesSulfur CompoundsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of DrugsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Andrew T Hattersley, FRCP, DM, BM

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 7, 2014

Study Start

March 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(5)