None listed
Conditions
Interventions
This 31 week study is a single centre, randomised parallel group comparison with a crossover of treatment at 12 weeks. The study will consist of a 6 week run-in period of a stable dose of Diamicron equivelant to the previous sulphonylurea dose.(Table 4) Followed by a 12 week period to either Diamicron MR or Amaryl once daily in random order. (Table 3)
During the Diamicron run-in phase and prior to randomisation to either Diamicron MR or Amaryl, the patients will be fitted with the Minimed Co
This 31 week study is a single centre, randomised parallel group comparison with a crossover of treatment at 12 weeks. The study will consist of a 6 week run-in period of a stable dose of Diamicron equivelant to the previous sulphonylurea dose.(Table 4) Followed by a 12 week period to either Diamicron MR or Amaryl once daily in random order. (Table 3) During the Diamicron run-in phase and prior to randomisation to either Diamicron MR or Amaryl, the patients will be fitted with the Minimed Continuous Glucose Monitor and instructed in the appropriate care and calibration procedure. Continuous monitoring will take place for three days. Prior to crossover of treatment at 12 weeks and prior to completion of the study at 28 weeks, the Continuous Glucose Monitor will be re-fitted for 3 days monitoring of interstitial glucose values.
Sponsors
Sydney Diabetes Clinical Research Unit
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who have been informed of the study procedure and have given written informed consent. 2. Unequivocal diagnosis of Type 2 diabetes mellitus. 3. Glycosylated haemoglobin (HbA1c) 7.5%. 4. Currently regularly taking any sulphonylurea drug. May also be on one or more additional oral antidiabetic medications other than repaglinide. 5. Oral antidiabetic medication dose stable for at least 8 weeks.
Exclusion criteria
1. Type 1 diabetes mellitus. 2. Unstable diabetes mellitus. 3. Myocardial infarction, transient ischaemic attacks or stroke in the last 6 months. 4. Symptomatic heart failure. 5. Diastolic blood pressure 100mmHg despite drug treatment. 6. Severe hepatic insufficiency. ALT 2.5 times the upper limit of the reference range. 7. Severe renal insufficiency. Serum creatinine 135mol/L. 8. Haemoglobinopathy or haemoglobin 10.5g/dl9. Malignant disease in the previous 10 years (except basal cell carcinoma). 10. Conditions which may affect blood glucose levels including: 11. Recent surgery (within the last 6 weeks) or surgery scheduled during the study period. 12. Systemic or generalised infections (bacterial, viral or fungal), including intercurrent illnesses in the last 6 weeks. 13. Concomitant glucocorticoid drug therapy. 14. Cushing's or Addisons disease. 15. Patients known to be immunocompromised (e.g., lymphoma, AIDS). 16. Known hypersensitivity to glucose oxygenase, the enzyme contained in the monitor probe. 17. Concomitant insulin therapy. 18. hypersensitivity to gliclazide, glimepiride or other suphonylureas. 19. Miconazole treatment.
Outcome results
None listed