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Sponsored by: |
Rijnstate Hospital |
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Information provided by: | Rijnstate Hospital |
ClinicalTrials.gov Identifier: | NCT00151697 |
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.
Condition | Intervention | Phase |
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Diabetes Mellitus Type II |
Drug: Novomix 30 Drug: Novorapid and Amaryl Drug: Lantus |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment |
Estimated Enrollment: | 150 |
Study Start Date: | May 2005 |
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.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hans de Boer, MD, PhD | +31-263788888 | HdeBoer@alysis.nl |
Netherlands | |
Rijnstate Hospital | Recruiting |
Arnhem, Netherlands, 6800 TA | |
Contact: Marianne de Man, MD +31-263788888 Mman@alysis.nl | |
Sub-Investigator: Marianne de Man, MD |
Principal Investigator: | Hans de Boer, MD, PhD | Rijnstate Hospital |
Study ID Numbers: | LTC 297-161104 |
Study First Received: | September 8, 2005 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00151697 |
Health Authority: | Netherlands: Dutch Health Care Inspectorate |
diabetes failing oral treatment weight gain |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Weight Gain Insulin Body Weight Glimepiride |
Diabetes Mellitus, Type 2 Glargine Insulin, Asp(B28)- Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Hypoglycemic Agents Immunologic Factors Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Agents Anti-Arrhythmia Agents Immunosuppressive Agents Pharmacologic Actions |