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…in an academic collaboration with. ISRCTN 51125379 www.dtu.ox.ac.uk/4-T. Collaborative academic and pharmaceutical study Three-year, multi-centre trial of addition of anlogue insulin to oral hypoglycaemic agents in 700 patients with Type 2 diabetes Open-label, three arm comparison of:

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…in an academic collaboration with

ISRCTN 51125379

www.dtu.ox.ac.uk/4-T


4 t design l.jpg

Collaborative academic and pharmaceutical study

Three-year, multi-centre trial of addition of anlogue insulin to oral hypoglycaemic agents in 700 patients with Type 2 diabetes

Open-label, three arm comparison of:

Basal insulin, given once (or twice) daily

Prandial insulin, given three times daily

Biphasic insulin, given twice daily

50 secondary-care based UK clinical centres

Funded by Novo Nordisk

4-T Design


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4-T Trial Organisation

Steering Committee

Overall responsibility for scientific, professionaland operational conduct of the study

Diabetes Trials Unit

Study Design & Protocol

Co-ordinating Centre

Web-based data collection

Clinical queries

Statistical analyses

Publication

Novo Nordisk

Study Design & Protocol

Site initiation & monitoring Investigator agreements

Ethical & regulatory aspects

Study medication

SAE reporting

DTU CentralLaboratory

Clinical Centres


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Main decision-making body of the Study

Responsible for protocol design

Ensure overall scientific, professional and operational conduct

Review performance of clinical centres, co-ordinating centre, central laboratory and centre monitors on a monthly basis

Steering Committee Remit


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Professor Rury Holman (Chair)

Dr Jonathan Levy (Co-chair)

Dr Andrew Farmer (Academic GP)

Ms Joanne Keenan (DTU Project Manager)

Dr Melanie Davies (Independent Diabetologist)

Mr George Nelson (Patient Representative)

Dr Alan McDougall (Novo Nordisk)

Dr Henrik Schou (Novo Nordisk)

Dr Mari-Anne Gall (Novo Nordisk)

Steering Committee Membership


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Add prandial insulinif glycaemic target not met†

Add midday prandial insulin if glycaemic target not met†

R

Add basal insulinif glycaemic target not met†

Twoyears

Threeyears

Three Way Randomisation

Glycaemic target: HbA1c ≤6.5%

Add once (or twice) daily basal insulin*

700 T2DMon OAD

Add twice daily biphasic insulin*

Add thrice daily prandial insulin*

Randomisationvisit

Oneyear

*progress to more intensive insulin regimen only if clinically necessary

†stop sulphonylurea if taken


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Impact of adding a single insulin preparation to OHAAbility of the three different analogue insulin preparations to achieve good glycaemic control, defined as HbA1C levels ≤ 6.5 %, evaluated over 12 months

Need for more complex insulin regimensLonger term efficacy and durability of the three insulin preparations, as well as the need for a second analogue insulin preparation to be added in order to achieve good glycaemic control, evaluated in the second and third years of the study

Insulin dose calculatorStudy data will be used to derive algorithms that estimate individual insulin requirements, starting doses and titration steps

4-T Main Study Objectives


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Aged ≥18 years, male and female

Type 2 diabetes for at least 12 months

On maximal tolerated doses of metformin and sulphonylurea for at least four months

Body mass index ≤40 kg/m2

HbA1c 7.0 % to 10.0 % inclusive

Written informed consent

Major Inclusion Criteria


Major exclusion criteria l.jpg

Taking insulin therapy

Taking oral antidiabetic therapy other than sulphonylurea and/or metformin

Plasma creatinine >130 µmol/L

ALT ≥2x upper limit of normal

Life threatening cardiovascular disease

Participation in a clinical drug trialwithin the last three months

Lactating or potentially pregnant females

Major Exclusion Criteria


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Primary Outcome and Sample Size

  • The primary objective is to compare the HbA1c levels achieved by the three insulin regimens

  • Formal analyses will be performed at one year and at three years, without adjustment for multiple comparisons, as the two phases of the study are regarded as separate experiments

  • 4-T has 95% power to show equivalence between groups at the 5% level of significance if 233 patients per group are randomised, assuming an HbA1c standard deviation of 1.1 and a dropout rate that does not exceed 15%


Three level hypoglycaemia classification l.jpg

Grade 2:Minorepisode

Plasma glucose<3.1 mmol/L (<56 mg/dl)

Grade 3:Majorepisode

Assistancerequired

Three-level Hypoglycaemia Classification

Plasma glucose ≥3.1 mmol/L,(≥56 mg/dl)or not measured

Grade 1:Symptomsonly

Treated bysubject alone

Hypoglycaemicepisode


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Safety Assessments

  • Incidence of major hypoglycaemic episodes

  • Incidence of unexpected and/orserious adverse events (SAEs)

  • Plasma ALT, creatinine and lipid levels

  • Stop metformin if plasma creatinine ≥150 µmol/L

  • Blood pressure


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Schedule

  • The study commenced 1st November 2004

  • 50 UK centres have been enrolled

  • 18 patients per centre will be recruited

  • One year results expected in 2007

  • Three year results expected in 2009


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First point of contact/triage for all queries

Email: [email protected]

Phone: 01865 857 239

Fax: 01865 857 248

Web site: www.dtu.ox.ac.uk/4-T

Co-ordinating Centre


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