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Trial registered on ANZCTR


Registration number
ACTRN12612001272886
Ethics application status
Approved
Date submitted
11/11/2012
Date registered
7/12/2012
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of oral antidiabetic drugs with insulin in the treatment of Gestational Diabetes Mellitus.
Scientific title
A phase three open label Randomized Controlled Trial to compare the efficacy of oral anti-diabetic drugs with insulin in the treatment of GDM
Secondary ID [1] 281593 0
Nil
Universal Trial Number (UTN)
U1111-1136-5177
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 287732 0
Condition category
Condition code
Reproductive Health and Childbirth 288074 288074 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 288240 288240 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin: Women with fasting blood sugar 95-109 mg/dl will be started on 250mg per oral twice daily and women with fasting blood sugar 110 - 125 mg/dl will be started on 500mg per oral twice daily, half to one hour before meal, which will be increased to achieve glycemic targets (i.e. fasting blood sugar <95mg/dl and post meal blood sugar <120 mg/dl) to a maximum dose 850mg thrice daily.

Glibenclamide: If glycemic control is not achieved on Metformin alone, Glibenclamide 2.5mg per oral per day will be added and increased till a maximum dose of 20mg per day as required.
Intervention code [1] 286160 0
Treatment: Drugs
Comparator / control treatment
Short acting (regular) Insullin will be injected subcutaneously 15-30 minutes pre breakfast, pre lunch and pre dinner and Intermediate-acting insulin will be injected subcutaneously at bedtime. Dose will be calculated according to body weight.

If only Fasting Blood Sugar (FBS) is high, then only bed time Intermediate-acting insulin will be started at a dose of 0.1 - 0.2 units/kg.

If only one or two post prandials are high, then regular insulin at a dose of 0.1 - 0.15 units/kg will be started before a particular meal.

If all the values are high, then basal bolus insulin will be started as Intermediate-acting insullin 0.1 - 0.2 units/kg at bed time and regular insulin 0.1 - 0.15 units/kg before each meal.

Treatment will be continued till delivery.
Control group
Active

Outcomes
Primary outcome [1] 288278 0
As per standard care women did self monitoring of blood glucose (SMBG) and maintained record of SMBG. This data was recorded on excel files. The outcome was assessed from determining average fasting blood glucose (FBG) and average post meal blood glucose recorded in excel files, for (a) 15 days prior to delivery (b) from recruitment to delivery. Following criteria was used for judgement of glycemic control: Excellent control - FBG < 95 mg/dl, Post Prandial < 120 mg/dl Satisfactory control - FBG 95 - 110 mg/dl, Post Prandial 120 - 140 mg/dl. Uncontrolled - FBG > 110 mg/dl, Post Prandial > 140 mg/dl.
Timepoint [1] 288278 0
At the time of admission in the hospital for child birth average blood sugars over 15 days prior to delivery will be calculated from the SMBG chart, as mentioned above.
Secondary outcome [1] 299743 0
Acceptability to treatment will be assessed on structured questionairre.
Timepoint [1] 299743 0
Before discharge of the subject from hospitalization for child birth.
Secondary outcome [2] 300144 0
Cost of treatment. The clinical trial unit pharmacy of Aga Khan University will maintain drug log for each subject. The pharmacy will calculate the cost from this log.
Timepoint [2] 300144 0
Cost will be calculated at the end of study period of that particular subject.

Eligibility
Key inclusion criteria
Women diagnosed as GDM, according to criteria given in the protocol.

Singleton pregnancy.

Women who consented for study.
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-gestational type 1 and type 2 diabetes mellitus
Overt diabetes (FBG > or equal to 126 mg/dl, Hb A1C > or equal to 6.5%)
Gestational age > 33 weeks at the time of recruitment.
Patients on steroid therapy
Women not tolerating Oral Glucose Tolerance Test.

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)
A sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block Randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4660 0
Pakistan
State/province [1] 4660 0
Sindh

Funding & Sponsors
Funding source category [1] 286239 0
University
Name [1] 286239 0
Aga Khan University
Address [1] 286239 0
Stadium Road,
P.O. Box 3500,
Postcode 74800
Karachi.
Country [1] 286239 0
Pakistan
Primary sponsor type
Individual
Name
Dr Aisha Syed Wali
Address
Department of Obstetrics and Gynaecology
Aga Khan University Hospital Stadium Road,
P.O. Box 3500,
Postcode 74800,
Karachi.
Country
Pakistan
Secondary sponsor category [1] 285046 0
None
Name [1] 285046 0
Address [1] 285046 0
Country [1] 285046 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288319 0
Ethica Review Committee, Aga Khan University
Ethics committee address [1] 288319 0
Dr. Shaista Khan
Chairperson, Ethical Review Committee
Professor
Department of Surgery
Aga Khan University
Stadium Road,
Postcode 74800,
Karachi.
Ethics committee country [1] 288319 0
Pakistan
Date submitted for ethics approval [1] 288319 0
Approval date [1] 288319 0
22/12/2010
Ethics approval number [1] 288319 0
1681-Obs-ERC-2010.

Summary
Brief summary
Our purpose is to compare the efficacy of oral hypoglycemic agents with insulin in treatment of Gestational diabetes in our population.
Until now the studies have compared either of Metformin or Glibenclamide with insulin. We will study both the drugs in combination where required. Our hypothesis is that oral hypoglycemic agents (Metformin alone or with Glibenclamide where required ) are as effective as insulin in achieving glycemic control in GDM. Moreover oral agents will be much more cost effective and acceptable to pregnant women of mid-low socioeconomic population of Pakistan.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34896 0
Dr Aisha Syed Wali
Address 34896 0
Department of Obstetrics & Gynecology, The Indus Hospital, Korangi Crossing, Postcode.75190 Karachi, Pakistan.

Country 34896 0
Pakistan
Phone 34896 0
+92 300 2510261
Fax 34896 0
Email 34896 0
aisha.wali@tih.org.pk
Contact person for public queries
Name 18143 0
Dr Aisha Sheikh
Address 18143 0
Department of Medicine
Aga Khan University Hospital
Stadium Road,
P.O. Box 3500,
Postcode 74800,
Karachi.
Country 18143 0
Pakistan
Phone 18143 0
+92 21 34864448
Fax 18143 0
Email 18143 0
aisha.sheikh@aku.edu
Contact person for scientific queries
Name 9071 0
Dr Aisha Syed Wali
Address 9071 0
Department of Obstetrics & Gynecology, The Indus Hospital, Korangi Crossing, Postcode.75190 Karachi, Pakistan.
Country 9071 0
Pakistan
Phone 9071 0
+92 300 2510261
Fax 9071 0
Email 9071 0
aisha.wali@tih.org.pk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary