Type 2 DiabetesPhase 4NCT00606034
U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
A Phase 4 study testing U-500 Insulin delivered by Omnipod (disposable insulin pump) in people with Type 2 Diabetes and Insulin Resistance, run by Mountain Diabetes and Endocrine Center at 1 site in United States.
Trial summary
Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Insulin Resistance
- What is being tested?
- U-500 Insulin delivered by Omnipod (disposable insulin pump)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes on stable insulin regimen with or without oral agents for at least 3 months
- HbA1c > 7%
- No significant cardiovascular, renal or other serious medical diseases
Who cannot join
- HbA1c < 7%
- Chronic renal, hepatic, cardiovascular, or other serious medical illness
- Females of childbearing age not using adequate contraception
- Use of GLP mimetic
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
About this study
Official title: A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens
Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.
Read the detailed description
Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.
- Conditions
- Type 2 Diabetes, Insulin Resistance
- Being tested
- U-500 Insulin delivered by Omnipod (disposable insulin pump)
- Keywords
- Type 2 diabetes, Insulin Resistance, Continuous Subcutaneous Insulin Infusion, U-500 Insulin, Omnipod
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-500 Insulin delivered by Omnipod (disposable insulin pump)Drug
U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs
| Study group | Role | What they receive |
|---|---|---|
| All subjects active | Experimental | All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens. Receives: Drug: U-500 Insulin delivered by Omnipod (disposable insulin pump) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)
HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.
Measured: 1 year
Secondary outcomes (2)
Percentage of Time Spent in Hypoglycemia
For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.
Measured: baseline versus 12 months
Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)
Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.
Measured: Baseline versus 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mountain Diabetes and Endocrine Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Lane MD, Mountain Diabetes and Endocrine Center
- Investigators
- Wendy S Lane, MD, Principal investigator, Mountain Diabetes and Endocrine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606034
- Sponsor's protocol ID
- U-500R
- Other IDs
- U500, B5K-US-X009
- Status last verified
- Jan 2014
- First submitted
- 19 Jan 2008
- Last updated
- 6 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lane WS. Use of U-500 regular insulin by continuous subcutaneous insulin infusion in patients with type 2 diabetes and severe insulin resistance. Endocr Pract. 2006 May-Jun;12(3):251-6. doi: 10.4158/EP.12.3.251.
PubMed 16772195
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens
- ClinicalTrials.gov ID
- NCT00606034
- Acronym / sponsor ID
- U-500R
- Conditions
- Type 2 Diabetes, Insulin Resistance
- Keywords
- Type 2 diabetes, Insulin Resistance, Continuous Subcutaneous Insulin Infusion, U-500 Insulin, Omnipod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mountain Diabetes and Endocrine CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Feb 2008 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.
Detailed description
Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects active | Experimental | Drug: U-500 Insulin delivered by Omnipod (disposable insulin pump)All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes on stable insulin regimen with or without oral agents for at least 3 months
- HbA1c > 7%
- No significant cardiovascular, renal or other serious medical diseases
Key exclusion criteria (4 listed)
- HbA1c < 7%
- Chronic renal, hepatic, cardiovascular, or other serious medical illness
- Females of childbearing age not using adequate contraception
- Use of GLP mimetic
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 |
|---|---|---|
| U-500 Insulin delivered by Omnipod (disposable insulin pump)U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs | Drug | All subjects active |
Primary outcome
Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)
Time frame: 1 year
HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.
2 secondary outcomes
Percentage of Time Spent in Hypoglycemia
Time frame: baseline versus 12 months
Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)
Time frame: Baseline versus 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16772195Lane WS. Use of U-500 regular insulin by continuous subcutaneous insulin infusion in patients with type 2 diabetes and severe insulin resistance. Endocr Pract. 2006 May-Jun;12(3):251-6. doi: 10.4158/EP.12.3.251.
Related trials for Type 2 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
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Wendy S Lane, MD principal investigator
Mountain Diabetes and Endocrine Center
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 U-500 Insulin delivered by Omnipod (disposable insulin pump) in people with Type 2 Diabetes and Insulin Resistance, run by Mountain Diabetes and Endocrine Center 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 3 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 6 Feb 2014. 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 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?
Yes. Results are posted in the registry (first posted 30 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00606034, which also lists 1 linked publication.
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 6 Feb 2014.