Diabetes MellitusPhase 2NCT01067118
A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.
A Phase 2 study testing LINjeta U-100 Insulin and Humalog U-100 in people with Diabetes Mellitus, run by Stanford University at 2 sites in United States.
Trial summary
The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- LINjeta U-100 Insulin and Humalog U-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Jun 2011
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide level and antibody determinations are not needed.
- 2) Age : 18 years old ¨C 49.99 years old 3) Continuous subcutaneous insulin infusion (CSII) therapy for at least 3 months 4) Participant consent demonstrated by signing IRB approved documents 6) HgA1c ¡Ü 9% 7) If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative. Exclusion Criteria:1) Chronic oral steroid use
- 2) The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of sensors or the completion of any aspect of the protocol.
- 3) Known clinical history of celiac disease or inflammatory bowel disease. 4) Participants will have a negative anti-endomysial antibody or anti-tissue transglutaminase antibody within one year of enrollment.
- 5) Cystic Fibrosis 6) Inpatient psychiatric treatment in the past 6 months. 7) Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
- 8) Clinical diagnosis of gastroparesis. 9) Insulin binding capacity greater than 10 microunits per litter
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver School of Medicine Barbara Davis Center
Denver, Colorado, 80045
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Ultra-Short Acting Insulin Versus Short Acting Insulin Effect on Postprandial Hyperglycemia AKA RCT Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Glycemia
The purpose of this study is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal.
- Conditions
- Diabetes Mellitus
- Being tested
- LINjeta U-100 Insulin, Humalog U-100
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINjeta U-100 InsulinDrug
Also called VIAject U-100
LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors
Humalog U-100Drug
Also called Lispro U-100 insulin
Normal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors
| Study group | Role | What they receive |
|---|---|---|
| Humalog U-100 Insulin | Active comparator | Not described Receives: Drug: Humalog U-100 |
| LINjeta U-100 | Experimental | Not described Receives: Drug: LINjeta U-100 Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal.
Measured: 2 weeks
The primary endpoint for this second phase is the 3 hour area under the curve from baseline following a standardized breakfast meal in the outpatient setting.
Measured: 2 weeks
The primary endpoint for this third phase is daytime (6 am to midnight) average glucose values.is percent of CGMS glucose values in range (70-180 mg/dL) for the third week fo sensor data in each group.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2011 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: The study was suspended due to lack of study drug
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.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Biodel, University of Colorado, Denver
- Responsible party
- Principal investigator, Bruce A. Buckingham, Stanford University
- Investigators
- Bruce A. Buckingham, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067118
- Sponsor's protocol ID
- SU-01292010-4823
- Other IDs
- 17579
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2010
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-Short Acting Insulin Versus Short Acting Insulin Effect on Postprandial Hyperglycemia AKA RCT Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Glycemia
- ClinicalTrials.gov ID
- NCT01067118
- Acronym / sponsor ID
- SU-01292010-4823
- Conditions
- Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was suspended due to lack of study drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Biodel, University of Colorado, Denver
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 11 Feb 2010 (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 is to determine if the use of Linjeta(tm) insulin when compared to Humalog will result in significantly lower episodes of hyperglycemia and hypoglycemia after a breakfast meal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humalog U-100 Insulin | Active comparator | Drug: Humalog U-100 |
| LINjeta U-100 | Experimental | Drug: LINjeta U-100 Insulin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The diagnosis of type 1 diabetes is based on the investigator¡-s judgment; C peptide level and antibody determinations are not needed.
- 2) Age : 18 years old ¨C 49.99 years old 3) Continuous subcutaneous insulin infusion (CSII) therapy for at least 3 months 4) Participant consent demonstrated by signing IRB approved documents 6) HgA1c ¡Ü 9% 7) If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative. Exclusion Criteria:1) Chronic oral steroid use
- 2) The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of sensors or the completion of any aspect of the protocol.
- 3) Known clinical history of celiac disease or inflammatory bowel disease. 4) Participants will have a negative anti-endomysial antibody or anti-tissue transglutaminase antibody within one year of enrollment.
- 5) Cystic Fibrosis 6) Inpatient psychiatric treatment in the past 6 months. 7) Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LINjeta U-100 InsulinAlso: VIAject U-100LINjeta U-100 Insulin will be used per the subjects normal insulin carbohydrate and insulin sensitivity factors | Drug | LINjeta U-100 |
| Humalog U-100Also: Lispro U-100 insulinNormal short acting insulin used in participants daily life including carbohydrate ratios and insulin sensitivity factors | Drug | Humalog U-100 Insulin |
Primary outcome
The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal.
Time frame: 2 weeks
The primary endpoint for this second phase is the 3 hour area under the curve from baseline following a standardized breakfast meal in the outpatient setting.
Time frame: 2 weeks
The primary endpoint for this third phase is daytime (6 am to midnight) average glucose values.is percent of CGMS glucose values in range (70-180 mg/dL) for the third week fo sensor data in each group.
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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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.
Bruce A. Buckingham principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LINjeta U-100 Insulin and Humalog U-100 in people with Diabetes Mellitus, run by Stanford University at 2 sites 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 0 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: withdrawn, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint for this first phase is the 3 hour area under the curve from baseline following a standardized breakfast meal. (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 10 Feb 2017.