DiabetesPhase 4NCT00566124
Basal Insulins - Pharmacodynamics
A Phase 4 study testing Insulin detemir, Insulin glargine and Insulatard in people with Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Insulin detemir, Insulin glargine and Insulatard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to May 2005
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- BMI 20 - 50 kg/m2
- Blood pressure < 140/90 mmHg
- signed informed consent
- Caucasien
Who cannot join
- Diabetes or other disease
- Alcohol or drug abuse
- Smoking
- Use of prescription drugs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, DK, 8000
About this study
Official title: No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans
To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.
Read the detailed description
In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design. After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).
- Conditions
- Diabetes
- Being tested
- Insulin detemir, Insulin glargine, Insulatard
- Keywords
- Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin detemirDrug
Also called Levemir
0.4 U/kg bw insulin detemir injected s.c. in the thigh.
Insulin glargineDrug
Also called Lantus
0.4 U/kg bw insulin glargine injected s.c. in the thigh
InsulatardDrug
0.4 U/kg bw NPH insulin injected s.c. in the thigh
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Insulin detemir Receives: Drug: Insulin detemir |
| 2 | Active comparator | Insulin glargine Receives: Drug: Insulin glargine |
| 3 | Active comparator | NPH insulin Receives: Drug: Insulatard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startJan 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Diabetes Association, The Institute of Experimental Clinical Research, University of Aarhus, Novo Nordisk A/S
- Investigators
- Ole E. Schmitz, DMSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566124
- Sponsor's protocol ID
- Opus 1
- Other IDs
- 2004-41-4474, 20040188, 2612-2731
- Status last verified
- Nov 2007
- First submitted
- 30 Nov 2007
- Last updated
- 3 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans
- ClinicalTrials.gov ID
- NCT00566124
- Acronym / sponsor ID
- Opus 1
- Conditions
- Diabetes
- Keywords
- Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Diabetes Association, The Institute of Experimental Clinical Research, University of Aarhus, Novo Nordisk A/S
- Study start
- Jan 2005
- Study completion
- May 2005 (actual)
- First posted
- 3 Dec 2007 (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.
To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.
Detailed description
In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design. After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Insulin detemirInsulin detemir |
| 2 | Active comparator | Drug: Insulin glargineInsulin glargine |
| 3 | Active comparator | Drug: InsulatardNPH insulin |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- BMI 20 - 50 kg/m2
- Blood pressure < 140/90 mmHg
- signed informed consent
- Caucasien
Key exclusion criteria (4 listed)
- Diabetes or other disease
- Alcohol or drug abuse
- Smoking
- Use of prescription drugs
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 detemirAlso: Levemir0.4 U/kg bw insulin detemir injected s.c. in the thigh. | Drug | 1 |
| Insulin glargineAlso: Lantus0.4 U/kg bw insulin glargine injected s.c. in the thigh | Drug | 2 |
| Insulatard0.4 U/kg bw NPH insulin injected s.c. in the thigh | Drug | 3 |
Primary outcome
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.
Time frame: 24 hours
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 3 Dec 2007.
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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.
Ole E. Schmitz, DMSc principal investigator
University of Aarhus
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 glargine and Insulatard in people with Diabetes, run by University of Aarhus 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 4 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 3 Dec 2007. 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?
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2007.