MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes

NCT01847144 | Completed Phase 4

• 2 other identifiers: CRF111MR/K005707/1
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have little effect in one person but a large effect in another. Understanding mechanisms of altered response to treatment could aid treatment selection and assist the design of new medications with lower nonresponse rates. This study will examine the physiological mechanisms and potential clinical/biomarker predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering medication and answer fundamental methodological questions for the future study of variation in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy for up to 2 weeks with assessment of baseline characteristics and glycaemic response. Participants will then enter an optional extension where they receive sulphonylurea or DPPIV inhibitor therapy in crossover fashion.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in fasting glucose

  Change in fasting glucose from 0 to 4 weeks post treatment change.

  4 weeks post treatment change

Secondary Outcomes (1)

• Additional changes in biochemical results

  4 weeks

Study Arms (2)

Gliclazide - Sitagliptin

ACTIVE COMPARATOR

Gliclazide 80mg OD and Sitagliptin 100mg OD

Drug: Gliclazide 80mg OD

Sitagliptin - Gliclazide

ACTIVE COMPARATOR

Gliclazide 80mg OD and Sitagliptin 100mg OD

Drug: Sitagliptin 100mg OD

Interventions

Gliclazide 80mg OD DRUG

Gliclazide 80mg OD (DPP-IV inhibitor) - for 4 weeks duration followed by a 2 week wash-out period.

Also known as: DPP-IV inhibitor

Gliclazide - Sitagliptin

Sitagliptin 100mg OD DRUG

Sitagliptin 100mg OD (sulphonylurea)- for 4 weeks duration followed by a 2 week wash-out period.

Also known as: sulphonylurea OD

Sitagliptin - Gliclazide

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 and \<80
• Clinical diagnosis of Type 2 Diabetes
• Currently treated with sulphonylurea tablets
• No change in diabetes treatment (new treatments or dose change) within last 3 months
• Last HbA1c (taken within last 12 months) of ≥42 mmol/mol and ≤75 mmol/mol (6-9%)
• Able and willing to monitor home blood glucose
• Able and willing to give informed consent

You may not qualify if:

• Current treatment includes: insulin, GLP-1 agonists, DPP-IV inhibitors, glinides
• Renal impairment (eGFR \<30 ml/min/1.73m2)
• Active infection (any infection requiring antibiotics at present)
• Recent (within 3 months) surgery or planned surgery
• Cardiovascular disease (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months
• Previous history of pancreatitis
• Pregnant, breastfeeding or planning a pregnancy over the study period
• Unable/unwilling to monitor home blood glucose

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University of Exeter: collaborator

Study Sites (1)

NIHR Exeter Clinical Research Facility, Royal Devon & Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Gliclazide; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Andrew T Hattersley, FRCP, DM, BM

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: May 6, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 21, 2018

Record last verified: 2018-06

Locations

GB (1)