Diabetes Type 2Phase 4Le-NaNCT00742976
Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients
A Phase 4 study testing Insulin Detemir; Insulin Insulatard and Insulin Detemir, Insulin Insulatard in people with Diabetes Type 2 and Weight Gain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Type 2, Weight Gain
- What is being tested?
- Insulin Detemir; Insulin Insulatard and Insulin Detemir, Insulin Insulatard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- 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 blood glucose (except oral antidiabetics)
- Use of drugs that may influence sodium balance,i.e diuretics ( tiazides accepted)
- Clinical significant disease that may influence outcome ( cancer etc)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of Endocrinology, Rigshospitalet
Copenhagen, København Ø, DK_2100
About this study
Official title: Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients
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.
Read the 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 hypothesize 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.
- Conditions
- Diabetes Type 2, Weight Gain
- Being tested
- Insulin Detemir; Insulin Insulatard, Insulin Detemir, Insulin Insulatard
- Keywords
- Weight gain in insulin treated type 2 diabetes, extracellular volume, insulin treatment, sodium retention
- Medical subject headings
- Diabetes Mellitus, Type 2, Weight Gain, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Detemir; Insulin InsulatardDrug
Dosage is individual but fixed in study period (if possible). Detemir is given once daily, Insulatard is given twice daily.
Insulin Detemir, Insulin InsulatardDrug
Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 8 weeks of insulin Detemir, then cross over to 8 Weeks of Insulatard, then cross over to 1 week of Detemir Receives: Drug: Insulin Detemir, Insulin Insulatard |
| 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 Receives: Drug: Insulin Detemir; Insulin Insulatard; Drug: Insulin Detemir, Insulin Insulatard |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight; change in extracellular volume
Measured: 17 weeks
Secondary outcomes (1)
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
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Tonny Jensen, M.D MSci., Principal investigator, Dept of Endocrinology at Rigshospitalet, Copenhagen.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742976
- Sponsor's protocol ID
- EudraCT 2008-001602-16
- Acronym
- Le-Na
- Status last verified
- Jun 2008
- First submitted
- 27 Aug 2008
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hendriksen KV, Jensen T, Oturai P, Feldt-Rasmussen B. Effects of insulin detemir and NPH insulin on renal handling of sodium, fluid retention and weight in type 2 diabetic patients. Diabetologia. 2012 Jan;55(1):46-50. doi: 10.1007/s00125-011-2345-8. Epub 2011 Oct 16.
PubMed 22002075
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention and Weight in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00742976
- Acronym / sponsor ID
- Le-Na / EudraCT 2008-001602-16
- Conditions
- Diabetes Type 2, Weight Gain
- Keywords
- Weight gain in insulin treated type 2 diabetes, extracellular volume, insulin treatment, sodium retention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 hypothesize 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Insulin Detemir, Insulin Insulatard8 weeks of insulin Detemir, then cross over to 8 Weeks of Insulatard, then cross over to 1 week of Detemir |
| 2 | Active comparator | Drug: Insulin Detemir; Insulin Insulatard, Drug: Insulin Detemir, Insulin Insulatard8 weeks of Insulin Insulatard, then cross over to 8 weeks of insulin Detemir, then crossover to 1 week of Insulin Insulatard |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (11 listed)
- Hypertension not well regulated
- Serum creatinine > 130 micromol/l
- Non-diabetic kidney disease
- Disease that may cause invalid hgbA1c measurement
- Substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Detemir; Insulin InsulatardDosage is individual but fixed in study period (if possible). Detemir is given once daily, Insulatard is given twice daily. | Drug | 2 |
| Insulin Detemir, Insulin InsulatardFixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily. | Drug | 1, 2 |
Primary outcome
change in weight; change in extracellular volume
Time frame: 17 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Derived from this study: PubMed 22002075Hendriksen KV, Jensen T, Oturai P, Feldt-Rasmussen B. Effects of insulin detemir and NPH insulin on renal handling of sodium, fluid retention and weight in type 2 diabetic patients. Diabetologia. 2012 Jan;55(1):46-50. doi: 10.1007/s00125-011-2345-8. Epub 2011 Oct 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonny Jensen, M.D MSci. principal investigator
Dept of Endocrinology at Rigshospitalet, Copenhagen.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Detemir; Insulin Insulatard and Insulin Detemir, Insulin Insulatard in people with Diabetes Type 2 and Weight Gain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in weight; change in extracellular volume (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00742976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.