NCT02109978

Brief Summary

This study will examine extreme responders to second- and third-line Type 2 Diabetes (T2D) therapy using a retrospective approach and patients with slow or fast diabetes progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
562

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

3 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

April 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

April 8, 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 and rate of diabetes progression

    The primary outcome will be to compare the clinical characteristics of the patients who show an excellent response or poor response to specific second- and third- line classes of treatment for Type 2 diabetes; and of those patients that show rapid progression of Type 2 diabetes or slow progression of Type 2 diabetes to markedly high blood glucose despite the treatment that they require.

    Within 9 months from date of recruitment

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 that have been taking a second- or third-line glucose-lowering treatment (Sulphonylurea, DPP-4 inhibitors, GLP-1R agonists, SGLT2 inhibitors, Glitazone or insulin) for at least 4 months.

Progressors

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

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
  • On Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone for \> 4 months.
  • Pre-treatment HbA1c≥ 58mmol/mol (7.5%).
  • Type 2 diabetes (not on insulin treatment within 6 months of diagnosis)
  • Either: requirement for insulin treatment ≤10 years from diagnosis (defined as insulin treatment or HbA1c ≥ 69mmol/mol (8/5%) treated with two or more non-insulin diabetes therapies) or: no requirement for insulin treatment \>10 years from diagnosis (defined as not on insulin treatment AND HbA1c \<69mmol/mol (8.5%).

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 (3)

University of Exeter

Exeter, Devon, EX2 5DW, United Kingdom

Location

University of Oxford

Oxford, Oxfordshire, OX1 2JD, United Kingdom

Location

University of Dundee

Dundee, DD1 9SY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

At Visit 1 a fasting blood sample (approximately 35 mls) will be taken 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.

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andrew T Hattersley, FRCP, DM, BM

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 10, 2014

Study Start

April 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 21, 2018

Record last verified: 2018-06

Locations

GB(3)