Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001216909
Ethics application status
Not yet submitted
Date submitted
22/11/2011
Date registered
25/11/2011
Date last updated
6/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing insulin therapy and insulin/ metformin combination therapy for Type 2 Diabetes Mellitus prevention
Scientific title
Monitoring and comparing the effects of insulin therapy and a combination of insulin and metformin therapy on glucose control in patients at risk of developing type 2 diabetes
Secondary ID [1] 273442 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 279229 0
Condition category
Condition code
Metabolic and Endocrine 279437 279437 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Experimental
Intervention: Daily subcutaneous insulin isophane injection therapy with a dosage adjusted by 2unit/week increments to get Fasting capillary blood glucose 4-5.6 mmol / L as the goal for a duration of 3 months. The dose range is 5-10 units of insulin.

2. Experimental
Intervention: Daily oral metformin 500 mg twice a day as a fixed dose and subcutaneous insulin isophane injection therapy with a dosage adjusted by 2unit/week increments to get Fasting capillary blood glucose 4-5.6 mmol / L as the goal for a duration of 3 months. The dose range is 5-10 units of insulin.

3. Control
Intervention: nil (standard lifestyle counseling).
Intervention code [1] 283773 0
Prevention
Intervention code [2] 283780 0
Treatment: Drugs
Comparator / control treatment
no treatment
standard lifestyle counseling
Control group
Active

Outcomes
Primary outcome [1] 286006 0
change in fasting plasma glucose

test: plasma analysis to determine the baseline values of 2-hour 75-g OGTT plasma glucose
Timepoint [1] 286006 0
at baseline and at 3 months and 12 months after intervention commencement
Primary outcome [2] 286007 0
change in glucose tolerance

test: plasma analysis using 2-hour 75-g OGTT plasma glucose
Timepoint [2] 286007 0
at baseline and at 3 months and 12 months after intervention commencement
Primary outcome [3] 286008 0
change in HbA1c

test: blood sample analysis using HbA1c test kit
Timepoint [3] 286008 0
at baseline and at 3 months and 12 months after intervention commencement
Secondary outcome [1] 294960 0
change in random blood

test: serum analysis using glucometer
Timepoint [1] 294960 0
at baseline and at 3 months and 12 months after intervention commencement
Secondary outcome [2] 294961 0
change in BMI
Timepoint [2] 294961 0
at baseline and at 3 months and 12 months after intervention commencement
Secondary outcome [3] 294962 0
number of participants that develop type 2 diabetes

test: fasting plasma glucose test and oral glucose tolerace test (OGTT) results will be compared against the diagnostic criteria of >7.0 mmol/L for fasting plasma glucose and >11.1mmol/L for OGTT
Timepoint [3] 294962 0
12 months after intervention commencement
Secondary outcome [4] 294963 0
number of participants that develops complications

test/ tools:
serum analysis using glucometer to check for hypoglycaemia.
questionnaires and medical reports to check and record other complications.
Timepoint [4] 294963 0
12 months after intervention commencement

Eligibility
Key inclusion criteria
21 years of age or older

Not specific to any gender or ethnic groups;

Persons with HbA1c between >= 5.7% and <6.5%;

Persons with impaired glucose tolerance or impaired fasting glucose levels
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known diabetes (Fasting Plasma Glucose > 7.0 mmol/l; 2-hour 75-g OGTT plasma glucose > 11.1 mmol/l;

HbA1c result HbA1c<5.7% or > =6.5%;

Diabetes diagnosed by a physician and confirmed by other clinical data;

Self-reported hospitalization for treatment of heart disease in past 6 months;

Impaired renal and liver function, and pancreatitis;

Self-reported recent or significant abdominal surgery;

Self-reported pregnancy and/or intentional pregnancy during the study;

Self-reported hospitalization for stroke or transient ischemic attack episode in the past 6 months;

Anemia;

Inability to ensure availability for the next 12 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 3971 0
Fiji
State/province [1] 3971 0

Funding & Sponsors
Funding source category [1] 284250 0
Charities/Societies/Foundations
Name [1] 284250 0
The Royal College of Pathologists of Australasia
Country [1] 284250 0
Australia
Funding source category [2] 284251 0
University
Name [2] 284251 0
The College of Medicine, Nursing, Health Sciences. Fiji National University
Country [2] 284251 0
Fiji
Primary sponsor type
Individual
Name
Rishaal Sharma
Address
P O Box 259
Labasa
Fiji

Hoodless House
Brown street
Suva
Fiji
Country
Fiji
Secondary sponsor category [1] 269205 0
None
Name [1] 269205 0
Address [1] 269205 0
Country [1] 269205 0
Other collaborator category [1] 260359 0
Individual
Name [1] 260359 0
Dr. Kamal Kishore
Address [1] 260359 0
Hoodless House
Brown street
Suva
Fiji
Country [1] 260359 0
Fiji

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286216 0
Ethics committee address [1] 286216 0
Ethics committee country [1] 286216 0
Date submitted for ethics approval [1] 286216 0
31/10/2011
Approval date [1] 286216 0
Ethics approval number [1] 286216 0

Summary
Brief summary
Diabetes is one of the most pressing health issues in Fiji today. It is estimated that 40% of Fiji’s population suffer from type 2 diabetes. Several public health strategies have been used to address this issue but there has not been a significant change in the figures. Therefore, pharmacological intervention may be of value in curbing the problem. Medical literature suggests that early therapy with insulin and oral hypoglycaemic agents are of benefit in delaying complications of diabetes in newly diagnosed patients. On this note, this proposed study will focus on the effectiveness of insulin therapy and insulin/metformin combination therapy in individuals with impaired glucose tolerance and impaired fasting glucose.

The study is based on the fact that impaired glucose tolerance to frank type2 diabetes is the progressive loss of insulin secretary capacity (functioning pancreatic beta cells). It is therefore, hypothesized that administration of insulin in patients at risk of developing diabetes will give time to the pancreatic beta cells to rest and regenerate. Animal studies have shown that high rate of glucose metabolism triggers beta cells to regenerate.

The proposed study will be based in Suva and include 45 subjects having an impaired glucose tolerance or an impaired fasting glucose. 15 patients will be given a dose of long-acting insulin, 15 patients will be given a combination dose of long-acting insulin/metformin, while the other 15 will be the control group. Serum insulin, HbA1c, BMI and 2-hour oral glucose tolerance results will be recorded at regular intervals. The study will proceed for 3 months. The study also involves the checking of the results after 1 year since the beginning of the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33427 0
Address 33427 0
Country 33427 0
Phone 33427 0
Fax 33427 0
Email 33427 0
Contact person for public queries
Name 16674 0
Dr. Kamal Kishore
Address 16674 0
Hoodless House
Brown street
Suva
Fiji
Country 16674 0
Fiji
Phone 16674 0
+679 9267466
Fax 16674 0
Email 16674 0
[email protected]
Contact person for scientific queries
Name 7602 0
Rishaal Sharma
Address 7602 0
Hoodless House
Brown street
Suva
Fiji
Country 7602 0
Fiji
Phone 7602 0
+679 9423556
Fax 7602 0
Email 7602 0
[email protected], [email protected]

No information has been provided regarding IPD availability


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.