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Sponsored by: |
Rigshospitalet, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00742976 |
Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir will increase their excretion of sodium in the urine and thereby decrease their extracellular volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is shifted while their body composition, sodium excretion, weight and extracellular volume is monitored.
Condition | Intervention | Phase |
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Diabetes Type 2 Weight Gain |
Drug: Insulin Detemir; Insulin Insulatard Drug: Insulin Detemir, Insulin Insulatard |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients |
Estimated Enrollment: | 24 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
8 weeks of insulin Detemir, then cross over to 8 Weeks of Insulatard, then cross over to 1 week of Detemir
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Drug: Insulin Detemir, Insulin Insulatard
Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.
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2: Active Comparator
8 weeks of Insulin Insulatard, then cross over to 8 weeks of insulin Detemir, then crossover to 1 week of Insulin Insulatard
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Drug: Insulin Detemir; Insulin Insulatard
Dosage is individual but fixed in study period (if possible). Detemir is given once daily, Insulatard is given twice daily.
Drug: Insulin Detemir, Insulin Insulatard
Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.
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Type 2 diabetic patients experience weight gain when receiving insulin treatment. There has been reports that the weight gain is less or absent when patients are treated with Insulin Detemir. Patients with diabetes have increased total body sodium and increased extracellular volume. We hypothethesize that part of the weight gain seen is due to increase in extracellular volume and that the lesser weight gain seen in patients treated with Detemir is due to an lesser increase in extracellular volume. We believe that the cause of this difference is the different pharmacokinetic properties of insulin Detemir. Insulin Detemir i protein bound and is therefore not excreted in the kidneys. This may cause less sodium reabsorption, than with other insulins, and therefore less increase in extracellular volume.
We test this hypothesis by examining urinary sodium excretion, extracellular volume by GFR measurements, Body composition by DEXA scan, body weight, and 24 hour blood pressure.In patients that are changed from Insulin Insulatard to Insulin Detemir and back.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tonny Jensen, M.D. DMSci | +45 35455218 | tonny.jensen@rh.regionh.dk |
Contact: Kirsten Vang Hendriksen, m.d | +45 35459552 | rh15539@rh.regionh.dk |
Denmark, København Ø | |
Dept of Endocrinology, Rigshospitalet | Recruiting |
Copenhagen, København Ø, Denmark, DK_2100 | |
Principal Investigator: Tonny Jensen, M.D.MSci |
Principal Investigator: | Tonny Jensen, M.D MSci. | Dept of Endocrinology at Rigshospitalet, Copenhagen. |
Responsible Party: | Dept. of Endocrinology; Rigshospitalet. ( Tonny Jensen ) |
Study ID Numbers: | EudraCT 2008-001602-16 |
Study First Received: | August 27, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00742976 |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency |
Weight gain in insulin treated type 2 diabetes extracellular volume insulin treatment sodium retention |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Urinary Retention Weight Gain Insulin, Isophane Insulin Body Weight |
Signs and Symptoms Diabetes Mellitus, Type 2 Hypernatremia Body Weight Changes Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |