A Phase 3 interventional study of Novomix 30 and Novorapid and Amaryl in Diabetes Mellitus Type II, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-08-09.
Sponsored by Rijnstate Hospital · Phase 3, Interventional, and Treatment
Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
Diabetic patients failing on maximal oral treatment usually switch to twice daily administration of a mixture of short- and longacting insulin. Although this improves glycemic control, it is generally accompanied by a substantial gain in body weight. This may lead to an increase in body fat resulting in a worsening of insulin resistance, leading to an increase in insulin dose needed to maintain glycemic control.
The combination of glimepiride(amaryl) and short-acting insulin (novorapid) is thought to attain glycemic control with a smaller increase in body weight.
In this randomized controlled trial, 150 diabetics failing on maximal oral treatment will be randomized to preprandial use of Novorapid combined with Amaryl at 20.00 hours, twice daily Novomix 30, or once daily Lantus. Metformin will be continued.
In the year after randomisation, patients will be followed for glycemic control, body weight, body composition, recorded number of hypoglycemic events, plasma lipid levels, basal and stimulated C-peptide levels and adverse effects.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 150 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Drug pages: Insulin Aspart · Glimepiride
glycemic control based on HbA1c
Body weight
8-point glucose day curve of three consecutive days
24-hour glycemic control measured by continuous glucose monitoring for three consecutive days
recorded number of hypoglycemic events per month
waist circumference
dexa measurements of body composition
plasma lipid levels
basal and stimulated C-peptide levels
adverse effects
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin Glargine