Testing insulin therapy and insulin/ metformin combination therapy for Type 2 Diabetes Mellitus prevention

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611001216909
• Date of registration: 25/11/2011
• Prospective Registration: Yes
• Primary sponsor: Rishaal Sharma
• 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
• Date of first enrolment: 04/08/2012
• Target sample size: 45
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12611001216909.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Assignment: Parallel;Type of endpoint: Safety/efficacy;

Countries of recruitment

Fiji

Contacts

• Name: Rishaal Sharma

• Name: Dr. Kamal Kishore

Key inclusion & exclusion criteria

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
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

Age minimum: 21 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Type 2 Diabetes;
Type 2 Diabetes

Metabolic and Endocrine - Diabetes

Intervention(s)

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).

Primary Outcome(s)

change in glucose tolerance

test: plasma analysis using 2-hour 75-g OGTT plasma glucose[at baseline and at 3 months and 12 months after intervention commencement]

change in fasting plasma glucose

test: plasma analysis to determine the baseline values of 2-hour 75-g OGTT plasma glucose[at baseline and at 3 months and 12 months after intervention commencement]

change in HbA1c

test: blood sample analysis using HbA1c test kit[at baseline and at 3 months and 12 months after intervention commencement]

Secondary Outcome(s)

change in BMI[at baseline and at 3 months and 12 months after intervention commencement]

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[12 months after intervention commencement]

change in random blood

test: serum analysis using glucometer[at baseline and at 3 months and 12 months after intervention commencement]

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.[12 months after intervention commencement]

Secondary ID(s)

NIL

Source(s) of Monetary Support

The College of Medicine, Nursing, Health Sciences. Fiji National University

The Royal College of Pathologists of Australasia

Ethics review

Status: Not approved
Approval date:
Contact: