Type 2 Diabetes MellitusPhase 2NCT00544206
Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
A Phase 2 study testing standard enteral feeding product and Diabetes specific feeding product in people with Type 2 Diabetes Mellitus, run by Abbott Nutrition at 1 site in United States.
Trial summary
To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- standard enteral feeding product and Diabetes specific feeding product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed and dated informed consent
- diagnosis of type 2 diabetes
- HbA1c between 7.0 and 9.0%
- 18 - 75 years of age
- currently receiving a standard enteral product
- anticipated duration on tube feeding at least one month
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- 100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support
- anticipated life expectancy is more than or equal to 6 months
- free of infections
- no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose
Who cannot join
- composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
- composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
- significant cardiovascular event less than or equal to 2 weeks prior to study entry
- major surgery less than or equal to 2 weeks prior to study entry
- pre-planned surgery during the study period
- active malignancy, including melanoma and excluding cutaneous malignancies
Show all 11Show fewer
- severe dementia
- known allergies to medical grade adhesives and/or skin disinfectants
- taking octreotide
- chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
- participation in a concomitant trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Segal Institute for Clinical Research
Miami, Florida, 33161
About this study
To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- standard enteral feeding product, Diabetes specific feeding product
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard enteral feeding productOther
16 hrs daily x 5 days
Diabetes specific feeding productOther
16 hrs daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| #1 | Experimental | Diabetes specific enteral feeding product Receives: Other: Diabetes specific feeding product |
| #2 | Active comparator | Standard enteral feeding product Receives: Other: standard enteral feeding product |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean glucose level
Measured: 24 hours
Secondary outcomes (1)
fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gordon Sacks, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544206
- Sponsor's protocol ID
- BK07
- Status last verified
- Sep 2008
- First submitted
- 12 Oct 2007
- Last updated
- 23 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther. 2010 Jun;12(6):419-25. doi: 10.1089/dia.2009.0185.
PubMed 20470226
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00544206
- Acronym / sponsor ID
- BK07
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 16 Oct 2007 (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.
To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| #1 | Experimental | Other: Diabetes specific feeding productDiabetes specific enteral feeding product |
| #2 | Active comparator | Other: standard enteral feeding productStandard enteral feeding product |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- signed and dated informed consent
- diagnosis of type 2 diabetes
- HbA1c between 7.0 and 9.0%
- 18 - 75 years of age
- currently receiving a standard enteral product
Key exclusion criteria (11 listed)
- composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products
- composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions
- significant cardiovascular event less than or equal to 2 weeks prior to study entry
- major surgery less than or equal to 2 weeks prior to study entry
- pre-planned surgery during the study period
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 |
|---|---|---|
| standard enteral feeding product16 hrs daily x 5 days | Other | #2 |
| Diabetes specific feeding product16 hrs daily for 5 days | Other | #1 |
Primary outcome
mean glucose level
Time frame: 24 hours
1 secondary outcome
fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin
Time frame: 24 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 23 Sep 2008.
- Derived from this study: PubMed 20470226Alish CJ, Garvey WT, Maki KC, Sacks GS, Hustead DS, Hegazi RA, Mustad VA. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. Diabetes Technol Ther. 2010 Jun;12(6):419-25. doi: 10.1089/dia.2009.0185.
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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.
Gordon Sacks, PhD principal investigator
University of Wisconsin, Madison
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 standard enteral feeding product and Diabetes specific feeding product in people with Type 2 Diabetes Mellitus, run by Abbott Nutrition 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 10 inclusion and 11 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 23 Sep 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 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?
mean glucose level (time frame: 24 hours). 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 NCT00544206, 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 23 Sep 2008.