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Trial registered on ANZCTR
Registration number
ACTRN12614000942651
Ethics application status
Approved
Date submitted
19/08/2014
Date registered
3/09/2014
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Date results provided
12/02/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Metformin versus insulin in the management of diabetes mellitus in pregnancy
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Scientific title
Metformin versus insulin in the management of diabetes mellitus in pregnancy at the Korle Bu Teaching Hospital
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Secondary ID [1]
285193
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nil
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Universal Trial Number (UTN)
U1111-1160-5026
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Trial acronym
MIS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus in pregnancy.
292799
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Condition category
Condition code
Metabolic and Endocrine
293093
293093
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: metformin only; starting dose 500mg taken orally twice daily and increased gradually every 2 weeks to a maximum dose of 2500mg or till optimum glycaemic control is attained. Treatment begins from enrolment till delivery.
Arm 2: insulin only; starting total daily dose of insulin is 0.3-1.0 i.u/kg body weight depending on glycaemic profile at diagnosis. This is titrated up to achieve optimum glycaemic control. Total daily dose of premixed insulin is divided into 2: 2/3 administered 30 min before breakfast and 1/3 administered 30 minutes before supper. insulin is administered subcutaneously in the deltoid region.
Insulin is administered from enrolment till delivery.
Arm 3: metformin +insulin for failures on arm 1
Failures on arm 1 means worsening glycaemic profile on OGTT i.e. fasting blood glucose greater 7.0 mmol/l or 2-hour post glucose greater 11.0 mmol/l after maximum dose adjustment.
Dose and duration of metformin and insulin in this arm is the same as their respective doses and durations in arms 1 and 2. Titration to higher doses is more aggressives to ensure strict control of glycaemic profile.
Adherence is monitored tablet and drug return on review visit
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Intervention code [1]
290060
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Treatment: Drugs
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Comparator / control treatment
Standard treatment:this is the same as the treatment in arm 2 above. starting total daily dose of insulin is 0.3-1.0 i.u/kg body weight depending on glycaemic profile at diagnosis. This is titrated up to achieve optimum glycaemic control. Total daily dose of premixed insulin is divided into 2: 2/3 administered 30 min before breakfast and 1/3 administered 30 minutes before supper. insulin is administered subcutaneously in the deltoid region.
For diabetic emergencie such diabetic ketoacidosis or when Fasting blood glucose is found at any time to be higher than 13.0 mmol/l subjects are admitted and managed on sliding scale with soluble insulin. in very severe cases the modified Alberti's regimen is used to rapidly reduce blood glucose levels. Before discharge, the total daily dose of soluble insulin is converted to premixed insulin and administered twice daily as above.
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Control group
Active
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Outcomes
Primary outcome [1]
292962
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2 hour blood glucose level in oral glucose tolerance test.
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Assessment method [1]
292962
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Timepoint [1]
292962
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At baseline, one month after enrollment and at 37 weeks gestation.
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Secondary outcome [1]
310026
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Maternal weight gain. It is measured with a calibrated analogue scale - Seca 'registered trade mark' (gmbh&Co. Kg Germany)
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Assessment method [1]
310026
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Timepoint [1]
310026
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Baseline to 37 weeks gestation.
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Eligibility
Key inclusion criteria
Pregnant with single fetus at gestational age of 20 to 30 weeks and have been diagnosed with Type 2 DM or Gestational Diabetes
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
patients with pre-gestational diabetes mellitus who require insulin to achieve glycaemic control and patients with contra-indications to metformin therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using Balloting
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2013
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Actual
2/01/2013
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Date of last participant enrolment
Anticipated
31/10/2013
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Actual
27/10/2013
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Date of last data collection
Anticipated
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Actual
15/02/2014
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Sample size
Target
104
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Accrual to date
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Final
104
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Recruitment outside Australia
Country [1]
6302
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Ghana
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State/province [1]
6302
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Greater Accra Region
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Funding & Sponsors
Funding source category [1]
289806
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Self funded/Unfunded
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Name [1]
289806
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Dr. Titus Beyuo
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Address [1]
289806
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Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
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Country [1]
289806
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Ghana
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Primary sponsor type
Individual
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Name
Dr. Titus Beyuo
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Address
Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
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Country
Ghana
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Secondary sponsor category [1]
288496
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None
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Name [1]
288496
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Address [1]
288496
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Country [1]
288496
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291539
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Ethical and Protocol Review committee of the University of Ghana Medical School
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Ethics committee address [1]
291539
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University of Ghana Medical School P O Box 4236 Accra
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Ethics committee country [1]
291539
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Ghana
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Date submitted for ethics approval [1]
291539
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Approval date [1]
291539
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21/12/2012
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Ethics approval number [1]
291539
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MS-Et/M.4 – P3.3/2012-13
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Summary
Brief summary
The objective of this study was to determine if either metformin monotherapy or metformin in combination with insulin is equally effective as insulin monotherapy at glycaemic control in diabetes mellitus in pregnancy among Ghanaians
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Titus Beyuo
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Address
50794
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Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
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Country
50794
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Ghana
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Phone
50794
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+233 200284332
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Fax
50794
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Email
50794
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[email protected]
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Contact person for public queries
Name
50795
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Titus Beyuo
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Address
50795
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Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
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Country
50795
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Ghana
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Phone
50795
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+233 200284332
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Fax
50795
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Email
50795
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[email protected]
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Contact person for scientific queries
Name
50796
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Titus Beyuo
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Address
50796
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Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
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Country
50796
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Ghana
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Phone
50796
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+233 200284332
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Fax
50796
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Email
50796
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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
Metformin versus insulin in the management of pre-gestational diabetes mellitus in pregnancy and gestational diabetes mellitus at the Korle Bu Teaching Hospital:A randomized clinical trial.
2015
https://dx.doi.org/10.1371/journal.pone.0125712
N.B. These documents automatically identified may not have been verified by the study sponsor.
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