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Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients (Le-Na)
This study is currently recruiting participants.
Verified by Rigshospitalet, Denmark, June 2008
Sponsored by: Rigshospitalet, Denmark
Information provided by: Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00742976
  Purpose

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
Diabetes Type 2
Weight Gain
Drug: Insulin Detemir; Insulin Insulatard
Drug: Insulin Detemir, Insulin Insulatard
Phase IV

MedlinePlus related topics: Diabetes Urine and Urination
Drug Information available for: Insulin Insulin Detemir Insulin, isophane
U.S. FDA Resources
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

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • change in weight; change in extracellular volume [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sodium excretion in urine, 24 hour blood pressure, body composition change,urine osmolality, urine albumin excretion, GFR, HbA1c, Blood lipid profile, NT-proBNP, plasma Albumin, Plasma metanephrines, aldosterone, active renin, angiotensin II [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

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
1: Active Comparator
8 weeks of insulin Detemir, then cross over to 8 Weeks of Insulatard, then cross over to 1 week of Detemir
Drug: Insulin Detemir, Insulin Insulatard
Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.
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
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes according to WHO 1999 criteria for at least 3 month
  • Insulin treated for at least 1 month
  • BMI 25-40
  • Age 18-80
  • Hb1Ac < 10%

Exclusion Criteria:

  • Hypertension not well regulated
  • Serum creatinine > 130 micromol/l
  • Non-diabetic kidney disease
  • Disease that may cause invalid hgbA1c measurement
  • Substance abuse
  • Recent use of Detemir
  • Pregnancy or risk of becoming pregnant
  • Any condition that may disturb protocol adherence (language barrier etc) urinary albumin > 30 mg/24hours ( before screening)
  • Use of drugs that may influence bloodglucose (except oral antidiabetics)
  • Use of drugs that may influence sodium balance (diuretics etc)
  • Clinical significant disease that may influence outcome ( cancer etc)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742976

Contacts
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

Locations
Denmark, København Ø
Dept of Endocrinology, Rigshospitalet Recruiting
Copenhagen, København Ø, Denmark, DK_2100
Principal Investigator: Tonny Jensen, M.D.MSci            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Tonny Jensen, M.D MSci. Dept of Endocrinology at Rigshospitalet, Copenhagen.
  More Information

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

Keywords provided by Rigshospitalet, Denmark:
Weight gain in insulin treated type 2 diabetes
extracellular volume
insulin treatment
sodium retention

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009