Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001094369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
17/08/2026
Date registered
Help: Date registered
4/09/2026
Date last updated
Help: Date last updated
4/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Optisulin vs NovoMix30 insulin in pregnant women with gestational diabetes
Scientific title
Efficacy of Optisulin vs NovoMix30 insulin in managing gestational diabetes in pregnant women
Additional trial identifiers [1] 318207 0
Nil
Universal Trial Number (UTN)
Trial acronym
OPTIMISE-GDM
Related trial records

Health condition
Health condition(s) studied:
Gestational diabetes 343263 0
Condition category
Condition code
Metabolic and Endocrine 339381 339381 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Novomix30 (30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine) by subcutaneous injection before dinner for insulin requiring gestational diabetes, from diagnosis to delivery (childbirth).
Initial dose: 14 units with dinner daily, adjusted to response (i.e. Fasting hyperglycaemia of BGL greater than or equal to 5.3 mmol/L for 2 days and no fasting or post-dinner hypoglycaemia
• If NovoMix 30 dose is less than 20 units, increase by 2 units
• If NovoMix 30 dose is greater than or equal to 20 units, increase by 4 units)
Participant diary of insulin doses administered and blood glucose levels as recorded on glucometer.
Intervention code [1] 335107 0
Treatment: Drugs
Description of the comparator or control
Optisulin (Insulin glargine) by subcutaneous injection at night for insulin requiring gestational diabetes, from diagnosis to delivery (childbirth).
Initial dose: 10 units at bedtime daily, adjusted to response (i.e. Fasting hyperglycaemia of BGL greater than or equal to 5.3 mmol/L for 2 days and no fasting hypoglycaemia
- If Optisulin dose is less than 20 units, increase by 2 units
- If Optisulin dose is greater than or equal to 20 units, increase by 4 units)
Control group
Active

Outcomes
Primary outcome [1] 346580 0
Glycaemic control
Timepoint [1] 346580 0
Fasting blood glucose level readings collected while on insulin therapy (continuous from commencement of insulin for diagnosis of insulin requiring gestational diabetes until delivery)
Secondary outcome [1] 466468 0
Hypoglycaemia
Timepoint [1] 466468 0
Incidence while on insulin therapy (continuous from commencement of insulin for diagnosis of insulin requiring gestational diabetes until delivery)
Secondary outcome [2] 466469 0
Maternal weight gain
Timepoint [2] 466469 0
From commencement of insulin for insulin requiring gestational diabetes to last clinic appointment (35-38 weeks) prior to delivery
Secondary outcome [3] 466472 0
Pre-eclampsia/Eclampsia
Timepoint [3] 466472 0
During pregnancy and delivery
Secondary outcome [4] 466473 0
Composite neonatal outcomes (birth weight, premature birth, birth trauma, neonatal hypoglycaemia, respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia).
Timepoint [4] 466473 0
At delivery

Eligibility
Key inclusion criteria
1. Pregnant women aged 18 years old and older
2. Diagnosed with Gestational Diabetes Mellitus using one or more of the following criteria:
- Fasting plasma glucose 5.3 – 6.9 mmol/L
- 75g oral glucose tolerance test: 1 hour plasma glucose greater or equal to 10.6 mmol/L or 2 hour plasma glucose 9.0 – 11.0 mmol/L
Or diagnosed with overt diabetes in pregnancy using one or more of the following criteria:
- Fasting plasma glucose greater or equal to 7.0 mmol/L
- 2 hour plasma glucose greater or equal to 11.1 mmol/L following a 75g 2 hour pregnancy oral glucose tolerance test
- HbA1c greater or equal to 6.5%
3. Insulin requiring GDM – i.e. GDM inadequately controlled on dietary and lifestyle interventions
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
- Multiple pregnancy (twins, triplets or more)
- Diagnosed with Type 1 Diabetes Mellitus, Type 3c Diabetes Mellitus, Cystic Fibrosis Related Diabetes
- Diagnosed with Type 2 Diabetes Mellitus prior to pregnancy
- Ongoing concurrent metformin use (while in study)
- Steroid induced hyperglycaemia

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 numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
15/03/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 30105 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 46500 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 322490 0
Hospital
Name [1] 322490 0
Canberra Hospital Department of Endocrinology
Country [1] 322490 0
Australia
Primary sponsor type
Hospital
Name
Canberra Hospital Department of Endocrinology
Address
Country
Australia
Secondary sponsor category [1] 325794 0
None
Name [1] 325794 0
Address [1] 325794 0
Country [1] 325794 0
Other collaborator category [1] 284068 0
Individual
Name [1] 284068 0
Dr Caitlin Corkhill, Co-Principal Investigator
Address [1] 284068 0
Country [1] 284068 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320970 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 320970 0
Ethics committee country [1] 320970 0
Australia
Date submitted for ethics approval [1] 320970 0
03/06/2026
Approval date [1] 320970 0
14/08/2026
Ethics approval number [1] 320970 0
2026.ETH.00162

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

Contacts
Principal investigator
Name 152238 0
Dr Nithin Kolanu
Address 152238 0
Department of Endocrinology, Canberra Hospital, Yamba Drive, Garran ACT 2605
Country 152238 0
Australia
Phone 152238 0
+61 251243794
Fax 152238 0
Email 152238 0
[email protected]
Contact person for public queries
Name 152239 0
Nithin Kolanu
Address 152239 0
Department of Endocrinology, Canberra Hospital, Yamba Drive, Garran ACT 2605
Country 152239 0
Australia
Phone 152239 0
+61 251243794
Fax 152239 0
Email 152239 0
[email protected]
Contact person for scientific queries
Name 152240 0
Nithin Kolanu
Address 152240 0
Department of Endocrinology, Canberra Hospital, Yamba Drive, Garran ACT 2605
Country 152240 0
Australia
Phone 152240 0
+61 251243794
Fax 152240 0
Email 152240 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ProtocolNo OPTIMISE-GDM – Protocol – V4 – 27 Aug 2026 Clean.docx

Documents added automatically
No additional documents have been identified.