Trial Review

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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
Scientific title
Metformin versus insulin in the management of diabetes mellitus in pregnancy at the Korle Bu Teaching Hospital
Secondary ID [1] 285193 0
nil
Universal Trial Number (UTN)
U1111-1160-5026
Trial acronym
MIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus in pregnancy. 292799 0
Condition category
Condition code
Metabolic and Endocrine 293093 293093 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 290060 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 292962 0
2 hour blood glucose level in oral glucose tolerance test.
Timepoint [1] 292962 0
At baseline, one month after enrollment and at 37 weeks gestation.
Secondary outcome [1] 310026 0
Maternal weight gain. It is measured with a calibrated analogue scale - Seca 'registered trade mark' (gmbh&Co. Kg Germany)
Timepoint [1] 310026 0
Baseline to 37 weeks gestation.

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with pre-gestational diabetes mellitus who require insulin to achieve glycaemic control and patients with contra-indications to metformin therapy

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using Balloting
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
2/01/2013
Date of last participant enrolment
Anticipated
31/10/2013
Actual
27/10/2013
Date of last data collection
Anticipated
Actual
15/02/2014
Sample size
Target
104
Accrual to date
Final
104
Recruitment outside Australia
Country [1] 6302 0
Ghana
State/province [1] 6302 0
Greater Accra Region

Funding & Sponsors
Funding source category [1] 289806 0
Self funded/Unfunded
Name [1] 289806 0
Dr. Titus Beyuo
Country [1] 289806 0
Ghana
Primary sponsor type
Individual
Name
Dr. Titus Beyuo
Address
Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
Country
Ghana
Secondary sponsor category [1] 288496 0
None
Name [1] 288496 0
Address [1] 288496 0
Country [1] 288496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291539 0
Ethical and Protocol Review committee of the University of Ghana Medical School
Ethics committee address [1] 291539 0
Ethics committee country [1] 291539 0
Ghana
Date submitted for ethics approval [1] 291539 0
Approval date [1] 291539 0
21/12/2012
Ethics approval number [1] 291539 0
MS-Et/M.4 – P3.3/2012-13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50794 0
Dr Titus Beyuo
Address 50794 0
Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
Country 50794 0
Ghana
Phone 50794 0
+233 200284332
Fax 50794 0
Email 50794 0
drbeyuo@gmail.com
Contact person for public queries
Name 50795 0
Titus Beyuo
Address 50795 0
Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
Country 50795 0
Ghana
Phone 50795 0
+233 200284332
Fax 50795 0
Email 50795 0
drbeyuo@gmail.com
Contact person for scientific queries
Name 50796 0
Titus Beyuo
Address 50796 0
Department of Obstetric and Gynaecology,
Korle Bu Teaching Hospital,
P O Box KB77
korle Bu, Accra.
Country 50796 0
Ghana
Phone 50796 0
+233 200284332
Fax 50796 0
Email 50796 0
drbeyuo@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseMetformin 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.2015https://dx.doi.org/10.1371/journal.pone.0125712
N.B. These documents automatically identified may not have been verified by the study sponsor.