Diabetes, Type IPhase 1ENM-HS-001NCT00810589
A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial
A Phase 1 study testing Levemir and Humalog NPL Insulin in people with Diabetes, Type I, run by Medical University of Graz at 1 site in Austria.
Trial summary
Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes have shown a prolonged and reproducible action profile of insulin detemir compared with NPH insulin and insulin glargine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Type I
- What is being tested?
- Levemir and Humalog NPL Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2008to Dec 2008
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities.
- Diagnosed with type 1 diabetes and treated with insulin
- Male or female subject between 18 and 65 years of age
- Body mass index between 18.0 and 32.0 kg/m2
- HbA1c (glycosylated haemoglobin A1c) ≤ 11%
- Fasting C-peptide ≤ 0.05 nmol/L
- Treatment with intensified insulin therapy or continuous subcutaneous human insulin or insulin analogue infusion (CSII)] for at least 3 months.
Who cannot join
- Known or suspected allergy to the trial products or related products,
- Previous participation (randomised) in this trial.
- The receipt of any investigational product within 3 months prior
- Clinically significant abnormal haematology or biochemistry screening tests
- Subject who is known to have hepatitis or who is a carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or has a positive result to the test for HIV antibodies.
- Supine blood pressure at screening (after 5 min in the supine position) ≥ 180 mmHg for systolic and/or ≥ 100 mmHg for diastolic. This exclusion criterion also pertains to subjects being on antihypertensives.
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- Clinically significant abnormal ECG at screening
- Subject who has donated blood in excess of 500 mL within the 9 weeks preceding screening.
- Significant history of alcoholism or drug/chemical abuse
- Smoker
- Subject with mental incapacity or language barriers
- Surgery or trauma with significant blood loss within the 9 weeks preceding screening.
- Subject with a history of or presence of cancer
- History of any illness or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject.
- Current systemic treatment with drugs that could interfere with glucose metabolism [such as systemic corticoids and monoamine oxidase (MAO) inhibitors] and/or pharmacokinetics.
- Subject who has proliferative retinopathy or maculopathy and/or severe neuropathy (in particular autonomic neuropathy)
- Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator and/or the sponsor.
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial to Compare the Pharmacodynamic Effects of Single Doses of Insulin Detemir and Neutral Protamin Lispro (NPL) Insulin in Subjects With Type 1 Diabetes
Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes have shown a prolonged and reproducible action profile of insulin detemir compared with NPH insulin and insulin glargine. Duration of action of insulin detemir has been reported to be up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is underestimated in glucose clamps lasting only 24 hours. This is so because a duration of action longer than 24 hours in individual clamps will be set to 24 hours in the mean calculation, whereas a shorter duration of action in individual clamps will be set to the true value.
It has been shown in clinical pharmacology trials that NPL insulin has an action profile comparable to NPH insulin in subjects with type 1 diabetes. , However, a direct comparison of pharmacodynamic properties of insulin detemir and NPL insulin has not been performed to date.
To get further insight into the pharmacodynamic properties of insulin detemir compared with NPL insulin, this trial has been designed to compare pharmacodynamics in general and duration of action in particular between insulin detemir and NPL insulin in subjects with type 1 diabetes.
Read the detailed description
Primary objective:
The primary objective is to compare the pharmacodynamic response of insulin detemir and NPL insulin with respect to duration of action in a 32-hour euglycaemic glucose clamp experiment following single dose administration in subjects with type 1 diabetes.
Secondary objectives:
The secondary objectives are:
- to additionally characterise the pharmacodynamic profiles of insulin detemir and NPL insulin in a 32-hour euglycaemic glucose clamp experiment following single dose administration in subjects with type 1 diabetes.
- to characterise the pharmacokinetic profiles of insulin detemir and NPL insulin following single dose administration in subjects with type 1 diabetes.
- to assess the safety and tolerability of insulin detemir and NPL insulin following single dose administration in subjects with type 1 diabetes.
Trial design:
This is a randomised, single centre, double-blind, two-period crossover trial. Each subject will be randomly allocated to two single dose administrations on two separate dosing visits.
Trial population:
Thirty (30) male and female subjects with type 1 diabetes [age 18-65 years (incl.) and body mass index between 18.0 and 32.0 kg/m2 (incl.)] will be randomised into the trial.
Assessments:
Pharmacodynamics: The glucose infusion rate and plasma glucose concentration will be measured during a euglycaemic glucose clamp running for 32 hours after dosing.
Pharmacokinetics: Serum concentrations of insulin detemir and insulin lispro will be measured frequently during the first 32 hours after dosing.
Safety: Adverse events, laboratory safety variables (haematology, biochemistry, urinalysis), physical examination, vital signs and hypoglycaemic episodes.
Trial products:
- Insulin detemir (Levemir® Novo Nordisk), 100 U/mL in 3 mL Penfill® cartridges
- Insulin lispro protamine suspension (Humalog® NPL, Eli Lilly), 100 U/mL in 3 mL cartridges
- Conditions
- Diabetes, Type I
- Being tested
- Levemir, Humalog NPL Insulin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevemirDrug
Also called Insulin Detemir
0,4 IE per kg bodyweight
Humalog NPL InsulinDrug
Also called Humalog NPL
0,4 IE per kg bodyweight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Levemir |
| 2 | Active comparator | Not described Receives: Drug: Humalog NPL Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of action, time from onset of action until end of action
Measured: 32 h
Secondary outcomes (1)
GIRmax, maximum glucose infusion AUCGIR,0-32h, AUCGIR,0-12h, AUCGIR,12-32h, tinf=0, Cmax,ins, tmax,ins, AUCins,0-24h AUCins,0-∞ AUCins,0-12h AUCins,12-24h
Measured: 0-32 h, 0-12 h, 0-24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type IStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Thomas R. Pieber, MD, Study director, Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810589
- Sponsor's protocol ID
- ENM-HS-001
- Acronym
- ENM-HS-001
- Status last verified
- Dec 2008
- First submitted
- 17 Dec 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial to Compare the Pharmacodynamic Effects of Single Doses of Insulin Detemir and Neutral Protamin Lispro (NPL) Insulin in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00810589
- Acronym / sponsor ID
- ENM-HS-001 / ENM-HS-001
- Conditions
- Diabetes, Type I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Dec 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.
Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes have shown a prolonged and reproducible action profile of insulin detemir compared with NPH insulin and insulin glargine. Duration of action of insulin detemir has been reported to be up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is underestimated in glucose clamps lasting only 24 hours. This is so because a duration of action longer than 24 hours in individual clamps will be set to 24 hours in the mean calculation, whereas a shorter duration of action in individual clamps will be set to the true value.
It has been shown in clinical pharmacology trials that NPL insulin has an action profile comparable to NPH insulin in subjects with type 1 diabetes. , However, a direct comparison of pharmacodynamic properties of insulin detemir and NPL insulin has not been performed to date.
To get further insight into the pharmacodynamic properties of insulin detemir compared with NPL insulin, this trial has been designed to compare pharmacodynamics in general and duration of action in particular between insulin detemir and NPL insulin in subjects with type 1 diabetes.
Detailed description
Primary objective:
The primary objective is to compare the pharmacodynamic response of insulin detemir and NPL insulin with respect to duration of action in a 32-hour euglycaemic glucose clamp experiment following single dose administration in subjects with type 1 diabetes.
Secondary objectives:
The secondary objectives are:
- to additionally characterise the pharmacodynamic profiles of insulin detemir and NPL insulin in a 32-hour euglycaemic glucose clamp experiment following single dose administration in subjects with type 1 diabetes.
- to characterise the pharmacokinetic profiles of insulin detemir and NPL insulin following single dose administration in subjects with type 1 diabetes.
- to assess the safety and tolerability of insulin detemir and NPL insulin following single dose administration in subjects with type 1 diabetes.
Trial design:
This is a randomised, single centre, double-blind, two-period crossover trial. Each subject will be randomly allocated to two single dose administrations on two separate dosing visits.
Trial population:
Thirty (30) male and female subjects with type 1 diabetes [age 18-65 years (incl.) and body mass index between 18.0 and 32.0 kg/m2 (incl.)] will be randomised into the trial.
Assessments:
Pharmacodynamics: The glucose infusion rate and plasma glucose concentration will be measured during a euglycaemic glucose clamp running for 32 hours after dosing.
Pharmacokinetics: Serum concentrations of insulin detemir and insulin lispro will be measured frequently during the first 32 hours after dosing.
Safety: Adverse events, laboratory safety variables (haematology, biochemistry, urinalysis), physical examination, vital signs and hypoglycaemic episodes.
Trial products:
- Insulin detemir (Levemir® Novo Nordisk), 100 U/mL in 3 mL Penfill® cartridges
- Insulin lispro protamine suspension (Humalog® NPL, Eli Lilly), 100 U/mL in 3 mL cartridges
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levemir |
| 2 | Active comparator | Drug: Humalog NPL Insulin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent obtained before any trial-related activities.
- Diagnosed with type 1 diabetes and treated with insulin
- Male or female subject between 18 and 65 years of age
- Body mass index between 18.0 and 32.0 kg/m2
- HbA1c (glycosylated haemoglobin A1c) ≤ 11%
Key exclusion criteria (18 listed)
- Known or suspected allergy to the trial products or related products,
- Previous participation (randomised) in this trial.
- The receipt of any investigational product within 3 months prior
- Clinically significant abnormal haematology or biochemistry screening tests
- Subject who is known to have hepatitis or who is a carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or has a positive result to the test for HIV antibodies.
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 |
|---|---|---|
| LevemirAlso: Insulin Detemir0,4 IE per kg bodyweight | Drug | 1 |
| Humalog NPL InsulinAlso: Humalog NPL0,4 IE per kg bodyweight | Drug | 2 |
Primary outcome
Duration of action, time from onset of action until end of action
Time frame: 32 h
1 secondary outcome
GIRmax, maximum glucose infusion AUCGIR,0-32h, AUCGIR,0-12h, AUCGIR,12-32h, tinf=0, Cmax,ins, tmax,ins, AUCins,0-24h AUCins,0-∞ AUCins,0-12h AUCins,12-24h
Time frame: 0-32 h, 0-12 h, 0-24 h
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 18 Dec 2008.
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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.
Thomas R. Pieber, MD study director
Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levemir and Humalog NPL Insulin in people with Diabetes, Type I, run by Medical University of Graz at 1 site in Austria.
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 7 inclusion and 18 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 18 Dec 2008. 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 Austria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Duration of action, time from onset of action until end of action (time frame: 32 h). 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 18 Dec 2008; AzTrials last refreshed its copy on 1 Nov 2026.