Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000152729
Ethics application status
Approved
Date submitted
21/12/2021
Date registered
31/01/2022
Date last updated
2/06/2023
Date data sharing statement initially provided
31/01/2022
Date results information initially provided
2/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of dulaglutide during low-energy diet in type 2 diabetes
Scientific title
A pilot study to test the safety, tolerability and feasibility of dulaglutide during a low-energy diet in type 2 diabetes
Secondary ID [1] 306090 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 324751 0
Obesity 324752 0
Condition category
Condition code
Metabolic and Endocrine 322202 322202 0 0
Diabetes
Diet and Nutrition 322203 322203 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20-25 people with type 2 diabetes mellitus (T2DM) will undergo total dietary replacement with low energy meal replacements from the Cambridge Weight Plan. Dietary replacement will consist of 4 x 200 kcal meal replacements, 2 x cups of non-starchy vegetables and 2.25 L of water per day. This will last for a total of 12 weeks. They will simultaneously be treated with 1.5mg weekly subcutaneous dulaglutide, a GLP-1 receptor agonist. The dulaglutide will be commenced 2 weeks prior to the total dietary replacement phase and will therefore be given for a total of 14 weeks.
Adherence to the intervention will be monitored through fortnightly contact, either face-to-face or by telephone.
Intervention code [1] 322499 0
Treatment: Drugs
Intervention code [2] 322500 0
Lifestyle
Intervention code [3] 322594 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329969 0
The primary outcome is the safety of the combination of a low energy diet and weekly dulaglutide. Safety endpoints will be assessed as adverse events and will be graded in severity on a scale of 1-5 using the Common Terminology Criteria for Adverse Events, version 5.
Timepoint [1] 329969 0
The total duration of the combination phase of this pilot study will be 12 weeks. Safety endpoints will be assessed at baseline as well as weeks 1, 2, 4, 6 ,8 10 and 12.
Primary outcome [2] 330099 0
The tolerability of the combination of a low energy diet plus weekly dulaglutide. This will be assessed based on patient reports through a study-specific questionnaire and a patient-administered Euroquol EQ-5D quality of life questionnaire.
Timepoint [2] 330099 0
The total duration of the combination phase of this pilot study will be 12 weeks. The EQ-5D quality of life questionnaire will be administered at baseline and week 12. Patients will be screened for adverse events using a study-specific questionnaire at weeks 1, 2, 4, 6, 8 , 10 & 12 following commencement of the low energy diet.
Secondary outcome [1] 404877 0
The feasibility of combining dulaglutide and a low energy diet in people with T2DM and an increased BMI. This will be assessed by discontinuation rates across the trial period via audit of study records.
Timepoint [1] 404877 0
This will continually assessed during the 12 week trial period with patient contact being made at weeks 1, 2, 4, 6, 8, 10 and 12.

Eligibility
Key inclusion criteria
• Able and willing to give written informed consent
• Men and women aged 20-65 years, all ethnicities
• T2DM of duration 0-6 years
• Eligible for funded dulaglutide under New Zealand PHARMAC special authority criteria
• Body mass index (BMI)>27 kg/m2 and <45 kg/m2
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Most recent HbA1c greater than 108mmol/mol (12%)
• Most recent eGFR less than 30 mls/min/1.732
• Substance abuse
• Known cancer
• Myocardial infarction or stroke within previous 6 months
• Learning difficulties
• Current treatment with anti-obesity drugs
• Diagnosed eating disorder or purging
• Pregnant or considering pregnancy
• People who have required hospitalisation for depression or are on antipsychotic drugs
• People currently participating in another clinical research trial
• People taking a monoamine oxidase inhibitor

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
1/11/2022
Actual
17/08/2022
Date of last data collection
Anticipated
31/01/2023
Actual
21/11/2022
Sample size
Target
25
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 24455 0
New Zealand
State/province [1] 24455 0
Auckland

Funding & Sponsors
Funding source category [1] 310432 0
Government body
Name [1] 310432 0
Waitemata District Health Board
Country [1] 310432 0
New Zealand
Primary sponsor type
Government body
Name
Waitemata District Health Board
Address
124 Shakespeare Road,
Takapuna,
Auckland 0620
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311587 0
None
Name [1] 311587 0
Address [1] 311587 0
Country [1] 311587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310070 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 310070 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 310070 0
New Zealand
Date submitted for ethics approval [1] 310070 0
25/02/2022
Approval date [1] 310070 0
05/05/2022
Ethics approval number [1] 310070 0
2022 FULL 11506

Summary
Brief summary
Type 2 diabetes mellitus (T2DM) is closely related to obesity. Previous studies have demonstrated that weight loss is an effective method of improving glycaemic control or even achieving remission of T2DM. Low Energy Diets (LEDs) have been shown to induce weight loss in people with diabetes and improve diabetes outcomes. However, despite their efficacy, they are difficult to maintain owing to hunger.

Dulaglutide is a GLP-1 receptor agonist used in the treatment of T2DM. It has multiple positive effects, including a modest weight loss which is at least in part due to an increase in satiety. Whilst both LED and dulaglutide are used in treatment of T2DM, the combination has not previously been explicitly tested. The rationale behind this study is that dulaglutide may improve adherence to a LED by reducing the hunger and food cravings associated with these dietary interventions.

We are proposing a pilot study to investigate the safety and tolerability of the combination of dulaglutide and a LED in people with T2DM and and obesity. The study will be unblinded and single arm and will last 12 weeks. Participants will all be treated with 1.5mg weekly dulaglutide and 800 kcal/day dietary replacement using products from the Cambridge Weight Plan.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116386 0
Dr Carl Peters
Address 116386 0
North Shore Hospital,
Waitemata District Health Board,
124 Shakespeare Road,
Takapuna,
Auckland 0620
Country 116386 0
New Zealand
Phone 116386 0
+64 21 297 5583
Fax 116386 0
Email 116386 0
Carl.Peters@waitematadhb.govt.nz
Contact person for public queries
Name 116387 0
Dr James Shand
Address 116387 0
North Shore Hospital,
Waitemata District Health Board,
124 Shakespeare Road,
Takapuna,
Auckland 0620
Country 116387 0
New Zealand
Phone 116387 0
+64 9 486 8900
Fax 116387 0
Email 116387 0
jamesshand123@gmail.com
Contact person for scientific queries
Name 116388 0
Dr James Shand
Address 116388 0
North Shore Hospital,
Waitemata District Health Board,
124 Shakespeare Road,
Takapuna,
Auckland 0620
Country 116388 0
New Zealand
Phone 116388 0
+64 9 486 8900
Fax 116388 0
Email 116388 0
jamesshand123@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small pilot study. There is likely limited utility in sharing individual data and there is some risk that individuals may be identifiable. Additionally, our pending ethics approval is contingent on the fact that patient data will only be shared between investigators.


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
Basic resultsNo 383332-(Uploaded-26-05-2023-10-56-42)-Basic results summary.docx
Plain language summaryNo In total, we enrolled 19 people in this pilot stud... [More Details]

Documents added automatically
No additional documents have been identified.