| CTRI Number |
CTRI/2024/05/066888 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Metformin and Insulin for managemnt of Blood Sugars and Pregnancy related Outcomes in the mother and Baby in women with Gestational Diabetes. |
|
Scientific Title of Study
|
A One-Year Randomized Trial of Metformin Versus Insulin for Glycemic Control and Maternal and Perinatal Outcomes in Gestational Diabetes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mrunalini Parasharam Patil |
| Designation |
MS Post graduate |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gyneacology,
Jawaharlal Nehru Medical College,
Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590006
India |
| Phone |
9686157970 |
| Fax |
|
| Email |
mrunalini.virgo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Patil |
| Designation |
Professor and Guide |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynaecology,
KAHERs Jawaharlal Nehru Medical College, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845565454 |
| Fax |
|
| Email |
kamalpatil1967@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Patil |
| Designation |
Professor and Guide |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynaecology,
KAHERs Jawaharlal Nehru Medical College, Nehru nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845565454 |
| Fax |
|
| Email |
kamalpatil1967@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Mrunalini Patil |
| Address |
Department of Obstetrics and Gynaecology,
KAHERs Jawaharlal Nehru Medical College, Nehru nagar, Belagavi 590010 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mrunalini Patil |
KAHERs Dr. Prabhakar Kore Hospital and medical research centre |
Department of Obstetrics and Gynaecology,
OPD no 10,
KAHERs Dr. Prabhakar Kore hospital and Medical Researxh Centre, Nehru nagar, belagavi
Belgaum
KARNATAKA |
9686157970
mrunalini.virgo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Insulin |
Insulin dose calculated by endocrinologist as per glycemic status.
For eg:
Inj Human Insulin 6-6-6 units could be the starting dose (dose is dependant of sugar levels) and then titrated as per subsequent sugar levels (checked biweekly or earlier if indicated) as per endocrinologist.
Insulin will started when glycemic control is not achieved by dietary and lifestyle medications and dosage will be titrated as per blood sugar levels (checked biweekly) until termination of pregnancy.
If need be, pharmacotherapy would be continued after delivery too. |
| Intervention |
Metformin |
Metformin dosage will be calculated by endocrinologist as per glycemic status.
For eg:
Tab Metformin 500mg OD will be the starting dose. If Patient is attaining by good glycemic control, same will be continued or dosage will be increased to Tab Metformin 500mg BD or increased to Tab Metformin 1000mg OD/BD.
Decision for the dosage and frequency will be made by the endocrinologist as her sugar levels on follow ups (checked biweekly)
Pharmacotherapy will be started once glycemic control is not attained by dietary and lifestyle modifications and continued until termination of pregnancy.
If need be, pharmacotherapy would be continued after delivery too. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant woman with diagnosed gestational diabetes (according to IADPSG criteria) needing pharmacological intervention/ anti-diabetic drugs.
2. Singleton pregnancy
3. 18 to 45 years of age
4. Gestational age of 14 to 35 weeks
|
|
| ExclusionCriteria |
| Details |
1. k/c/o diabetes mellitus
2. Chronic gastrointestinal disease
3. Women with gestational diabetes controlled on diet |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Maternal outcomes like mode of delivery, association with other obstetrical disorders(like gestational hypertension, pre term delivery, etc), conversion to overt DM, etc
2. Perinatal outcomes like birth weight, congenital anomalies, neonatal hypoglycemia, Jaundice, respiratory distress, NICU admission, etc |
During pregnancy, at delivery and postpartum. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Glycemic control
Safety profile
Conversion to overt DM |
From starting of pharmacotherapy in pregnancy until 6 weeks post partum |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mrunalini.virgo@gmail.com].
- For how long will this data be available start date provided 31-08-2025 and end date provided 27-08-2060?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study aims to compare the effectiveness and safety of Metformin versus insulin in managing gestational diabetes over a year-long randomized clinical trial. Through comprehensive analysis of maternal and perinatal outcomes, the study seeks to address the need for alternative treatments, considering metformin’s potential benefits in glycemic control and cost-effectiveness. This randomized, open labelled, prospective trial, conducted at KAHER’s Dr. Prabhakar Kore Charitable Hospital and MRC, Belagavi, will involve antenatal cases with gestational diabetes requiring pharmacotherapy, evaluating the efficacy of metformin as a pharmacological intervention. The study’s methodology includes randomization, regular follow-up assessments, and obstetric management, aiming to contribute valuable insights to gestational diabetes management paradigms. |