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Trial registered on ANZCTR


Registration number
ACTRN12614000204640
Ethics application status
Approved
Date submitted
18/02/2014
Date registered
26/02/2014
Date last updated
18/12/2018
Date data sharing statement initially provided
17/12/2018
Date results provided
17/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, open-label study using continuous glucose monitoring to compare the effects of once a day versus twice a day prednisolone dosing schedule on glycaemic control in people with type 2 diabetes mellitus.
Scientific title
A randomised, open-label study using continuous glucose monitoring to compare the effects of once a day versus twice a day prednisolone dosing schedule on glycaemic control in people with type 2 diabetes mellitus.
Secondary ID [1] 284070 0
Nil
Universal Trial Number (UTN)
U1111-1152-1267
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 291131 0
Condition category
Condition code
Metabolic and Endocrine 291473 291473 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral prednisolone twice a day given as 10 mg doses at 08:00 and 18:00 (time is 24 hour clock time), for 3 days. Adherence will be monitored by drug tablet return and participant diary. There is a wash-out period between treatments of 3 weeks.
Intervention code [1] 288763 0
Treatment: Drugs
Comparator / control treatment
Once a day morning oral dosing with 20 mg prednisolone given at 08:00), for 3 days. Adherence will be monitored by drug tablet return and participant diary. There is a wash-out period between treatments of 3 weeks.
Control group
Dose comparison

Outcomes
Primary outcome [1] 291449 0
The amount of time per day (% and area under the curve (AUC) of glucose-time curve with interstitial glucose level greater than or equal to 10.0 mmol/L.
Timepoint [1] 291449 0
Averaged from the 3 days of prednisolone dosing, data from continuous glucose monitoring system.
Secondary outcome [1] 306791 0
1. The amount of time per day (% and AUC of glucose-time curve) with interstitial glucose level > 15.0 mmol/L, assessed using continuous glucose monitoring system.
Timepoint [1] 306791 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [2] 306792 0
2. Average post-prandial interstitial glucose level excursion on steroid, assessed using continuous glucose monitoring system.
Timepoint [2] 306792 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [3] 306793 0
3. Average incremental AUCglucose post-breakfast, post-lunch and post-dinner, assessed using continuous glucose monitoring system.
Timepoint [3] 306793 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [4] 306794 0
4. Average fasting interstitial glucose level and average interstitial glucose level (24 hour average), assessed using continuous glucose monitoring system.
Timepoint [4] 306794 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [5] 306795 0
5. Timing of maximum and nadir interstitial glucose level (time of day and in relation to the time of steroid dose), assessed using continuous glucose monitoring system.
Timepoint [5] 306795 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [6] 306796 0
6. Mean interstitial glucose level during the following time blocks: 2400-1200; 1200-2400; 0800-1400; 1400-2000; 2000-0200; 0200-0800, assessed using continuous glucose monitoring system.
Timepoint [6] 306796 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [7] 306797 0
7. Glycaemic variability assessed using MAGE (mean amplitude of glycaemic excursion) index, standard deviation of glucose concentration, CONGA- 1, 2, 3, 4 (continuous overall net glycaemic action at 1, 2 , 3 or 4 hours), J-index.
Timepoint [7] 306797 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [8] 306798 0
8. The average difference between fasting interstitial glucose level and each of pre-lunch and pre-dinner interstitial glucose levels, assessed using continuous glucose monitoring system.
Timepoint [8] 306798 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [9] 306799 0
9. The average difference between peak post-breakfast interstitial glucose level and each of peak post-lunch and post-dinner interstitial glucose levels, assessed using continuous glucose monitoring system.
Timepoint [9] 306799 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [10] 306800 0
10. The amount of time per day (%) with interstitial glucose level < 4.0 mmol/L, assessed using continuous glucose monitoring system.
Timepoint [10] 306800 0
Averaged from the 3 days of prednisolone dosing.
Secondary outcome [11] 306801 0
11. Sleep quality score assessed by modified Pittsburgh Sleep Quality Index questionnaire
Timepoint [11] 306801 0
Day 3 of the prednisolone dosing.

Eligibility
Key inclusion criteria
1. Informed consent obtained before any trial-related activities
2. Male or female
3. Age greater than or equal to 18 years
4. Type 2 diabetes, diagnosis established from medical history
5. Duration of diabetes greater than or equal to 6 months
6. Stable daily dose of anti-diabetic medications for at least 60 days preceding the screening visit
7. HbA1c 6.5% to 9.9% (48 to 85 mmol/mol, both inclusive) at screening visit
8. Current treatment for diabetes: diet and exercise, metformin, a sulphonylurea, pioglitazone, a dipeptidyl peptidase 4 inhibitor, acarbose
9. Body mass index greater than or equal to 18 kg/m2 and less than or equal to 40 kg/m2
10. Able and willing to perform self-monitoring of glucose levels according to the protocol, to
keep a log sheet for glucose levels and food diary, and use the continuous glucose monitoring system.
11. Participant, if female, agrees to avoid pregnancy while participating in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes, gestational diabetes or secondary diabetes (e.g. Cushing’s syndrome)
2. On treatment with insulin within 60 days of the screening visit
3. On treatment with GLP-1 receptor agonists within 60 days of the screening visit
4. Pregnant, lactating or intends to become pregnant during the course of the study
5. Body mass index < 18 kg/m2 or > 40 kg/m2
6. Clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, renal, hepatic or haematological system (except for conditions associated with type 2 diabetes), that in the opinion of the Investigator, may confound the results of the trial
7. Severe uncontrolled treated or untreated hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >95 mm Hg)
8. Current or anticipated requirement for medications (e.g. oral or injected steroids required for arthritis or asthma or chronic pulmonary disease) or operations that will adversely affect glucose metabolism during the trial
9. Inability to perform self monitoring of glucose with a blood glucose meter.
10. Participation in another clinical trial. The participant must have completed any previous study at least 30 days before the screening visit.
11. Mental incapacity, unwillingness, language barrier or other factor that in the investigator’s opinion precludes adequate understanding of the trial procedure or cooperation with trial site personnel.
12. Abuse of alcohol or narcotics

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)
Allocation involves contacting the designated holder of the allocation schedule, who is an administration staff person from another department in the institute.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis
Sample size determination
No previous published studies have evaluated the effect of dosing regimen on interstitial glucose levels in people with T2 diabetes mellitus (T2DM). In a published study by Burt et al, the people with T2DM treated with glucocorticoid spent 21.5 +/- 8.1% of the total duration of CGMS with BGL greater than or equal to 10 mmol/L. Our sample size calculations are based on detection of a difference of 6.45% (30% of 21.5%) with 80% power and 5% level of significance. This requires a minimum of 25 participants; our study will have 30 participants (to allow for possible drop out).

ANALYSIS
Repeated measures ANOVA will be used to assess between treatment comparisons. A p value<0.05 will be considered significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
17/03/2014
Actual
2/07/2014
Date of last participant enrolment
Anticipated
Actual
15/01/2016
Date of last data collection
Anticipated
Actual
15/01/2016
Sample size
Target
30
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288704 0
Charities/Societies/Foundations
Name [1] 288704 0
Diabetes Australia Research Trust
Country [1] 288704 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
75 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 287407 0
None
Name [1] 287407 0
Address [1] 287407 0
Country [1] 287407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290541 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 290541 0
Ethics committee country [1] 290541 0
Australia
Date submitted for ethics approval [1] 290541 0
28/01/2014
Approval date [1] 290541 0
05/03/2014
Ethics approval number [1] 290541 0
41/14

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

Contacts
Principal investigator
Name 46166 0
Dr A Reutens
Address 46166 0
Baker IDI Heart and Diabetes Institute, PO Box 6492 St Kilda Rd Central, Melbourne VIC 8008
Country 46166 0
Australia
Phone 46166 0
61 3 8532 1800
Fax 46166 0
Email 46166 0
[email protected]
Contact person for public queries
Name 46167 0
A Reutens
Address 46167 0
Baker IDI Heart and Diabetes Institute, PO Box 6492 St Kilda Rd Central, Melbourne VIC 8008
Country 46167 0
Australia
Phone 46167 0
61 3 8532 1800
Fax 46167 0
Email 46167 0
[email protected]
Contact person for scientific queries
Name 46168 0
A Reutens
Address 46168 0
Baker IDI Heart and Diabetes Institute, PO Box 6492 St Kilda Rd Central, Melbourne VIC 8008
Country 46168 0
Australia
Phone 46168 0
61 3 8532 1800
Fax 46168 0
Email 46168 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing of the IPD was not mandatory when this trial was conducted and there was no mention of this in the PICF.


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
No additional documents have been identified.