Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Abu Ahmed

ORCID ID

Contact details

Diabetes Consultant
Blackpool
Fylde and Wyre Hospitals NHS Trust
Blackpool
FY3 8NR
United Kingdom
+44 (0)1253 306723
Abuahmeduk@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0301111201

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the effect of metformin on diabetes control in insulin dependent diabetes mellitus (IDDM)

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind cross-over controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Diabetes

Intervention

Metformin or placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

metformin

Primary outcome measures

Assessment of HbA1c and changes in fasting blood glucose during the study period

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

30/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

20 patients from the district diabetes register with body mass index (BMI) >27 with insulin-dependent diabetes mellitus (IDDM)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2002

Recruitment end date

30/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Diabetes Consultant
Blackpool
FY3 8NR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Blackpool Fylde & Wyre Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16978371

Publication citations

  1. Results

    Khan AS, McLoughney CR, Ahmed AB, The effect of metformin on blood glucose control in overweight patients with Type 1 diabetes., Diabet. Med., 2006, 23, 10, 1079-1084, doi: 10.1111/j.1464-5491.2006.01966.x.

Additional files

Editorial Notes