None listed
Conditions
Brief summary
The purpose of this research project is to evaluate a plan of action designed for general practitioners and practice nurses to safely and efficiently start patients with Type 2 diabetes on insulin injections who have high sugar (glucose) levels despite taking tablets. To be eligible to take part in this study subjects must have Type 2 diabetes; be aged between 18-80 years old; are on at least two diabetes tablets at the highest doses that they are able to tolerate and that these doses have been unchanged over the last 3 months, or based on the opinion of the general practitioner who normally cares for the patient insulin, is required to ensure ensure their health health. The subject must have a HbA1c (a simple laboratory measurement on blood that reflects average glucose levels in a person's blood over the previous three months) between 7.5-10.5% which indicates less than satisfactory diabetic control; and must have never taken insulin before. Women of childbearing age must not get pregnant during the study. There will be up to 142 subjects recruited for this study across 16 sites in Victoria Australia only. Participating subjects will be commenced on insulin initially with a single injection of an insulin (Glargine) which lasts for 24 hours. The dose will then be adjusted to match the subject’s needs. If necessary, because sugar levels rise after meals despite providing an appropriate dose of the long acting insulin, a second injection of a short acting insulin (Glulisine) will be added in to coincide with the subject’s biggest meal for the day. A second purpose of this study is to determine if a new device that provides information regarding a patient’s glucose levels continuously is helpful in guiding treatment that results in better control of diabetes when compared to current methods for monitoring glucose levels by finger-prick readings. The study will be looking to see if the protocol used improves sugar levels as measured by a fall in HbA1c which will be measured at the start of a subject's involvement in the study, at 12 weeks and at 24 weeks.
Interventions
glulisine and glargine insulin and continuous glucose monitoring. Glargine insulin is to be administered subcutaneously (SC) once daily for 24 weeks. Glulisine is to be administered subcutaneously (SC) once daily initially for a maximum of 20 weeks. Dosing of the insulin will be dependent upon the subjects glucose levels. Subjects are to be randomised to continuous glucose monitoring or conventional glucose monitoring. The frequency of the monitoring will be according to a pre-specified schedule
glulisine and glargine insulin and continuous glucose monitoring. Glargine insulin is to be administered subcutaneously (SC) once daily for 24 weeks. Glulisine is to be administered subcutaneously (SC) once daily initially for a maximum of 20 weeks. Dosing of the insulin will be dependent upon the subjects glucose levels. Subjects are to be randomised to continuous glucose monitoring or conventional glucose monitoring. The frequency of the monitoring will be according to a pre-specified schedule which will take into account the subject's glucose levels.
Sponsors
Sanofi Aventis
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Type 2 diabetes patients who are insulin naive. Age>18 Years<80 Years. At least 2 oral hypoglycaemic agents (metformin, sulphonylurea, Thiazolidindiones) at maximal tolerated doses, or in the opinion of the responsible medical practitioner, insulin is deemed necessary if the patient is on less than 2 oral hypoglycaemic agents. The doses of the oral hypoglycaemic agents should be stable for at least 3 months prior to enrollment into the study. Haemoglobin A1c(HbA1c)>7.0%. Willing to monitor glucose levels at least twice daily. Willing to commence insulin and comply with follow-up.
Exclusion criteria
Type 1 diabetes. Evidence of satisfactory fasting glucose levels (mean <6.0mmol/L) with post-prandial hyperglycaemia (mean >10.0mmol/L). Previous or current treatment with insulin (excluding the short term (<2weeks) use of insulin in acute illness or during hospitalization). Non-English speaking. Significant cognitive impairment. Impaired vision or any other physical handicap precluding reliable glucose monitoring administration of insulin. Significant renal impairment: estimated glomerular filtration rate (egfr)< 20. Any recent (<3months) or ongoing life-threatening illness. Needle phobia. Pregnancy or planned pregnancy. Major psychiatric disorder.
Outcome results
None listed