ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001168347

Ethics application status

Approved

Date submitted

25/07/2017

Date registered

9/08/2017

Date last updated

9/08/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Metformin in Pre-diabetes Patients and Stroke study

Scientific title

Evaluating the safety and tolerability of Metformin XR in patients with pre-diabetes admitted with a stroke.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pre-diabetes

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Metformin XR starting at 500mg daily and increase to a total daily dose of 1500mg daily after 1 month from intervention (If the dose of Metformin XR 500mg daily was tolerated at the one month follow up phone call, the dose will be tripled from 500mg daily to 1500mg daily. )
Intervention will commence within 6 week from stroke
The administartion is oral tablet
The duration of administartion will be 4 months
Compliance will check by counting the remaining tablets at 1 month and over 2.5 months from intervention over follow up phone calls

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Receiving usual care. Usual care for pre-diabetes includes advice on dietary and lifestyle improvements, advice of regular physical exercise and weight loss as well as advice on smoking cessation or avoidance.

Control group

Active

Outcomes

Primary outcome [1]

Safety and tolerability of Metformin XR assessed by using a validated side effects questionnaire
(Pereira DI, Couto Irving SS, Lomer MC, Powell JJ. A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation. BMC Gastroenterol. 2014 Jun 4;14:103. )

Timepoint [1]

4 month post commencement of intervention

Secondary outcome [1]

HbA1c levels measured in fasted blood samples using immunoassay method

Timepoint [1]

4 month post commencement of intervention

Secondary outcome [2]

fasting glucose levels measured using Hexokinase

Timepoint [2]

4 month post commencement of intervention

Secondary outcome [3]

C-peptide using ECLIA method

Timepoint [3]

4 month post commencement of intervention

Secondary outcome [4]

fasting lipid profile using enzymatic colorimetric method

Timepoint [4]

4 month post commencement of intervention

Secondary outcome [5]

blood pressure using digital blood pressure monitoring

Timepoint [5]

4 month post commencement of intervention

Secondary outcome [6]

urine albumin to creatinine ratio. Urea measured using Urease/GLDH and Creatinin by using Jaffe reaction method

Timepoint [6]

4 month post commencement of intervention

Secondary outcome [7]

body mass index calculated as weight /( height)2

Timepoint [7]

4 month post commencement of intervention

Secondary outcome [8]

waist circumference measured as the abdominal circumference just above the iliac crest in a standing and relaxed position

Timepoint [8]

4 month post commencement of intervention

Eligibility

Key inclusion criteria

Age more than 18 years
Had an ischaemic stroke or TIA who are stable at least with a 6 week period following stroke
Modified Rankin Scale less than or equal to 3
HbA1c levels 5.7 to 6.4%

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Age >90 years
Pre-existing diabetes
Estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2
Hepatic insufficiency (liver function tests >2x upper limit of normal)
Active drug or heavy alcohol use
Metastatic cancer
Pregnancy or breastfeeding
Weight less than 50kg
Use of hypoglycaemic agents, opioids, corticosteroids
Patients unlikely to survive for more than 6 months
Patients unavailable for repeated follow up and unlikely of participate in trial requirements, participation in other interventional trials

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

15/08/2017

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

40

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Stroke Foundation

Address [1]

Level 7, 461 Bourke Street, Melbourne VIC 3000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health, Dr Elif Ekinci

Address

145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria
Australia 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/01/2017

Approval date [1]

20/03/2017

Ethics approval number [1]

HREC/17/Austin/47

Summary

Brief summary

This is an off-label, randomized, open blinded end-point study to determine the safety and tolerability of Metformin XR administration starting at 500mg daily to a maximum total daily dose of 1500mg XR daily on discharge in patients with pre-diabetes (defined as an HbA1c of 5.7-6.4%) admitted with a stroke. 
During an acute stroke admission or following a recent stroke admission, patients who are recruited into the trial will be randomized (in a 1:1 ratio) to either the active arm, receiving Metformin or usual care for a total of 4 months. Usual care for pre-diabetes includes advice on dietary and lifestyle improvements, advice of regular physical exercise and weight loss as well as advice on smoking cessation or avoidance.
At baseline, we will record clinical and biochemical characteristics, cardiovascular risk factors and medication use. One month into the study, a phone call follow up will occur and participants in both groups will be asked to complete a side effect questionnaire and compliance determined. A second follow up phone call will occur at 2.5 months and participants will again be asked to complete the questionnaire and asked about compliance. 
Finally a physical study visit will be scheduled at four months following randomization. At this last visit, patients will complete the same questionnaire to determine their compliance and nature of any of the side-effects of the treatment. At both physical study visits, the fasting glucose levels, HbA1c, C-peptide, fasting lipid profile, blood pressure, urine albumin to creatinine ratio, body mass index (BMI), waist circumference, blood pressure, and lipid profile will be assessed.
Questions regarding side effects and completion of the side effect questionnaire during both follow up phone calls and second physical visit will be performed with a blinded investigator.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Elif Ekinci

Address

Level: 02 Room: 106, Boronia Building, Austin Repatriation Hospital
300 Waterdale Rd, Ivanhoe, VIC, 3079

Country

Australia

Phone

+61 (03) 9496 2250

Fax

Email

elif.ekinci@austin.org.au

Contact person for public queries

Name

Marjan Tabesh

Address

Level: 02 Room: 112, Boronia Building, Austin Repatriation Hospital,
300 Waterdale Rd, Ivanhoe, VIC, 3079

Country

Australia

Phone

+61 (03) 9496 2124

Fax

Email

mtabesh@student.unimelb.edu.au

Contact person for scientific queries

Name

Marjan Tabesh

Address

Level: 02 Room: 112, Boronia Building, Austin Repatriation Hospital
300 Waterdale Rd, Ivanhoe, VIC, 3079

Country

Australia

Phone

+61 (03) 9496 2124

Fax

Email

mtabesh@student.unimelb.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial.	2021	https://dx.doi.org/10.1016/j.jocn.2021.01.006

N.B. These documents automatically identified may not have been verified by the study sponsor.