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Glucose Response, Excursions And Treatment (GREAT) Study

NCT02506296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-04-12

No results posted yet for this study

Summary

Patients with type 2 diabetes have very variable endogenous insulin secretion. While some patients have relatively preserved endogenous insulin with marked insulin resistance others may develop the very severe insulin deficiency seen in type 1 diabetes. The impact of this variation on hypoglycaemia risk and treatment response in type 2 diabetes is unclear. This project aims to determine the impact of residual endogenous insulin secretion on glucose variability, hypoglycaemia risk and treatment response in insulin-treated participants with a clinical diagnosis of type 2 diabetes. The investigators will recruit participants from existing cohorts known to have severe insulin deficiency despite classical clinical characteristics of type 2 diabetes. The investigators will recruit other participants with insulin-treated type 2 diabetes and retained endogenous insulin secretion matched for glycemia and gender. The investigators will assess glucose variability (using continuous glucose monitoring system (CGMS)) and treatment response to a single dose of the glucose lowering therapy vildagliptin and compare responses between groups. This study will allow us to assess the potential utility of measuring endogenous insulin secretion in insulin-treated type 2 diabetes as a marker of hypoglycaemia risk and in determining likely response to oral therapy.

Conditions

Interventions

DRUG

DPPIV inhibitor -

Mixed Meal Tolerance Test with or without a DPPIV inhibitor

DEVICE

Continuous glucose monitoring system.

participant's will self-monitor blood glucose over a 4-6 day period via a CGM monitor inserted just under the skin.

Sponsors & Collaborators

  • NIHR Exeter Clinical Research Facility

    collaborator NETWORK

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Angus G Jones, PhD · NIHR Exeter Clinical Research Facility

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506296 on ClinicalTrials.gov