Diabetes MellitusPhase 2NCT01000922
A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro
A Phase 2 study testing Regular Human Insulin, Lispro and VIAject in people with Diabetes Mellitus, run by Biodel at 1 site in United States.
Trial summary
Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Regular Human Insulin, Lispro and VIAject
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2008
- Phase
- Phase 2
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of type 1 diabetes for not less than 5 years
- HbA1c values of not more than 9%
- Age: 19 to 70 years
- Sex: Male or Female
- Body Mass Index: 18 - 28 kg/m2
- Informed consent must be obtained in writing for all volunteers.
Who cannot join
- Type 2 Diabetes mellitus.
- History of hypersensitivity to any of the components in the study medication.
- History of severe or multiple allergies.
- Treatment with any other investigational drug in the last 1 month before study entry.
- Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
- Progressive disease likely to prove fatal (e.g. malignancies).
Show all 15Show fewer
- Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
- Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
- Blood donation within the last 30 days.
- A women who is lactating.
- Pregnant women or women intending to become pregnant during the study.
- A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
- Positive Serology for HIV, Hepatitis B or Hepatitis C.
- Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
- A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, 91911
About this study
Official title: A Single Center, Randomized, Open-Label, Crossover Study, Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro Either in Combination With a Basal Insulin Infusion or With Insulin Glargine Relative to a Standardized Meal in Patients With Type 1 Diabetes
Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.
- Conditions
- Diabetes Mellitus
- Being tested
- Regular Human Insulin, Lispro, VIAject, VIAject 50%, VIAject/Insulin Glargine
- Keywords
- Mealtime Insulin, Rapid acting insulin, Ultra fast VIAject, prandial insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Human InsulinDrug
Individual dose of RHI administered subcutaneously
LisproDrug
Individual dose of lispro administered subcutaneously
VIAjectDrug
Individual dose of VIAject administered subcutaneously
VIAject 50%Drug
Individual dose of VIAject 50% administered subcutaneously
VIAject/Insulin GlargineDrug
VIAject mixed wiht insulin glargine and administered subcutaneously
Insulin Glargine/VIAjectDrug
Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Regular Human Insulin | Experimental | Single injection Receives: Drug: Regular Human Insulin |
| Lispro | Experimental | Single injection Receives: Drug: Lispro |
| VIAject | Experimental | Single injection Receives: Drug: VIAject |
| VIAject 50% | Experimental | Single injection Receives: Drug: VIAject 50% |
| VIAject/Insulin glargine | Experimental | Single injection Receives: Drug: VIAject/Insulin Glargine |
| Insulin Glargine/VIAject | Experimental | Single injection Receives: Drug: Insulin Glargine/VIAject |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments
Measured: 8 hours
Secondary outcomes (1)
To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startJun 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcus Hompesch, MD, Principal investigator, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000922
- Sponsor's protocol ID
- VIAJECT™-010JM
- Status last verified
- Jul 2015
- First submitted
- 21 Oct 2009
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open-Label, Crossover Study, Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro Either in Combination With a Basal Insulin Infusion or With Insulin Glargine Relative to a Standardized Meal in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01000922
- Acronym / sponsor ID
- VIAJECT™-010JM
- Conditions
- Diabetes Mellitus
- Keywords
- Mealtime Insulin, Rapid acting insulin, Ultra fast VIAject, prandial insulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiodelIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 23 Oct 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.
Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Regular Human Insulin | Experimental | Drug: Regular Human InsulinSingle injection |
| Lispro | Experimental | Drug: LisproSingle injection |
| VIAject | Experimental | Drug: VIAjectSingle injection |
| VIAject 50% | Experimental | Drug: VIAject 50%Single injection |
| VIAject/Insulin glargine | Experimental | Drug: VIAject/Insulin GlargineSingle injection |
| Insulin Glargine/VIAject | Experimental | Drug: Insulin Glargine/VIAjectSingle injection |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Established diagnosis of type 1 diabetes for not less than 5 years
- HbA1c values of not more than 9%
- Age: 19 to 70 years
- Sex: Male or Female
- Body Mass Index: 18 - 28 kg/m2
Key exclusion criteria (15 listed)
- Type 2 Diabetes mellitus.
- History of hypersensitivity to any of the components in the study medication.
- History of severe or multiple allergies.
- Treatment with any other investigational drug in the last 1 month before study entry.
- Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
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 |
|---|---|---|
| Regular Human InsulinIndividual dose of RHI administered subcutaneously | Drug | Regular Human Insulin |
| LisproIndividual dose of lispro administered subcutaneously | Drug | Lispro |
| VIAjectIndividual dose of VIAject administered subcutaneously | Drug | VIAject |
| VIAject 50%Individual dose of VIAject 50% administered subcutaneously | Drug | VIAject 50% |
| VIAject/Insulin GlargineVIAject mixed wiht insulin glargine and administered subcutaneously | Drug | VIAject/Insulin glargine |
| Insulin Glargine/VIAjectIndividual dose of VIAject and Insulin Glargine administered seperately and subcutaneously | Drug | Insulin Glargine/VIAject |
Primary outcome
To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments
Time frame: 8 hours
1 secondary outcome
To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments.
Time frame: 8 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 29 Jul 2015.
Related trials for Diabetes Mellitus
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.
Marcus Hompesch, MD principal investigator
Profil Institute for Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regular Human Insulin, Lispro and VIAject in people with Diabetes Mellitus, run by Biodel at 1 site in United States.
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 6 inclusion and 15 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 29 Jul 2015. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments (time frame: 8 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 29 Jul 2015.