DiabetesPhase 1NCT00969592
Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers
A Phase 1 study testing insulin glulisine, insulin aspart and insulin aspart, insulin glulisine in people with Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
The purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- insulin glulisine, insulin aspart and insulin aspart, insulin glulisine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy males or females (Women: contraception, Pearl Index <1%)
- Between the ages of 18 and 65 years
- Body Mass Index of <= 27 kg/m²
- Safety lab within reference range
- Normal blood pressure and heart rate
- Sufficient venous access
- Written informed consent approved by the Ethical Review Board
- HbA1c and fasting plasma glucose in the normal range
Who cannot join
- Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees
- Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval
- Known allergies to insulin or related compounds
- Regular treatment with any drug, both over-the-counter or prescribed
- an abnormality in the 12-lead ECG increasing the risk for participation
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Show all 13Show fewer
- Significant active neuropsychiatric disease
- Regular use of drugs of abuse and or positive findings on urinary drug screening
- Evidence of HIV and/or positive antibodies 1 or 2 and or HIV1 antigen
- Evidence of hepatitis B and/or positive hepatitis C antibody
- Evidence of hepatitis B and/or positive hepatitis B surface antigen
- Women with a positive pregnancy test or breastfeeding women
- Blood donation more than 500 mL within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pharmacodynamics and Pharmacokinetics of the Two Fast-acting Insulin Analogs Insulin Glulisine and Insulin Aspart in Healthy Volunteers
The purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct head-to-head comparison during two euglycemic glucose clamps in healthy subjects.
Read the detailed description
In a previous glucose clamp study with a head-to-head comparison of insulin glulisine and insulin lispro it was shown that the onset of metabolic action was significantly shorter with insulin glulisine than with insulin lispro (while the total metabolic effect was not different). These results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro. The primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart. This was the first clinical study realizing a head-to-head comparison between these two insulin analogs.
- Conditions
- Diabetes
- Being tested
- insulin glulisine, insulin aspart, insulin aspart, insulin glulisine
- Keywords
- diabetes
- 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 glulisine, insulin aspartDrug
Also called Apidra, NovoRapid
single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during second euglycemic glucose clamp
insulin aspart, insulin glulisineDrug
Also called NovoRapid, Apidra
single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during second euglycemic glucose clamp
| Study group | Role | What they receive |
|---|---|---|
| insulin glulisine, insulin aspart | Active comparator | insulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp Receives: Drug: insulin glulisine, insulin aspart |
| insulin aspart, insulin glulisine | Active comparator | insulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp Receives: Drug: insulin aspart, insulin glulisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional and total glucose infusion rates
Measured: 0-1 hours, 0-2 hours, and time to 10% of GIRmax
Secondary outcomes (1)
fractional and total insulin areas under the curve (AUC)
Measured: 0-1 hours, 0-2 hours, 0-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionJun 2008
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Investigators
- Sabine Arnolds, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969592
- Sponsor's protocol ID
- 49-0361-GluAsp
- Status last verified
- Sep 2009
- First submitted
- 31 Aug 2009
- Last updated
- 2 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pharmacodynamics and Pharmacokinetics of the Two Fast-acting Insulin Analogs Insulin Glulisine and Insulin Aspart in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00969592
- Acronym / sponsor ID
- 49-0361-GluAsp
- Conditions
- Diabetes
- Keywords
- diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Sep 2009 (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.
The purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct head-to-head comparison during two euglycemic glucose clamps in healthy subjects.
Detailed description
In a previous glucose clamp study with a head-to-head comparison of insulin glulisine and insulin lispro it was shown that the onset of metabolic action was significantly shorter with insulin glulisine than with insulin lispro (while the total metabolic effect was not different). These results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro. The primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart. This was the first clinical study realizing a head-to-head comparison between these two insulin analogs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin glulisine, insulin aspart | Active comparator | Drug: insulin glulisine, insulin aspartinsulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp |
| insulin aspart, insulin glulisine | Active comparator | Drug: insulin aspart, insulin glulisineinsulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Overtly healthy males or females (Women: contraception, Pearl Index <1%)
- Between the ages of 18 and 65 years
- Body Mass Index of <= 27 kg/m²
- Safety lab within reference range
- Normal blood pressure and heart rate
Key exclusion criteria (13 listed)
- Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees
- Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval
- Known allergies to insulin or related compounds
- Regular treatment with any drug, both over-the-counter or prescribed
- an abnormality in the 12-lead ECG increasing the risk for participation
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 glulisine, insulin aspartAlso: Apidra, NovoRapidsingle subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during second euglycemic glucose clamp | Drug | insulin glulisine, insulin aspart |
| insulin aspart, insulin glulisineAlso: NovoRapid, Apidrasingle subcutaneous dose of 0.2 units per kg body weight of insulin aspart during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during second euglycemic glucose clamp | Drug | insulin aspart, insulin glulisine |
Primary outcome
fractional and total glucose infusion rates
Time frame: 0-1 hours, 0-2 hours, and time to 10% of GIRmax
1 secondary outcome
fractional and total insulin areas under the curve (AUC)
Time frame: 0-1 hours, 0-2 hours, 0-10 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 2 Sep 2009.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Sabine Arnolds, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
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 insulin glulisine, insulin aspart and insulin aspart, insulin glulisine in people with Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
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 8 inclusion and 13 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 2 Sep 2009. 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 Germany. 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?
fractional and total glucose infusion rates (time frame: 0-1 hours, 0-2 hours, and time to 10% of GIRmax). 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 2 Sep 2009.