Trials Sponsors Conditions Drugs Pricing

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Royal Devon and Exeter NHS Foundation Trust
Otherlead
King's College Hospital NHS Trust
Othercollaborator

Study Sites (5)

University of Exeter

Exeter, Devon, EX2 5DW, United Kingdom

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

University of Newcastle

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

University of Glasgow

Glasgow, G12 8TA, United Kingdom

King's College University of London

London, SE1 9NH, United Kingdom

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)

UreaAmides

Study Officials

Andrew T Hattersley, FRCP, DM, BM
University of Exeter
PRINCIPAL INVESTIGATOR

Enrollment

820 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

PROMASTER - PROspective Cohort MRC ABPI STratification and Extreme Response Mechanism in Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Responders

Progressors

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Responders

Progressors

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations