Type 2 Diabetes MellitusPhase 2NCT00520065
Comparison of Nutritional Products for People With Type 2 Diabetes
A Phase 2 study testing enteral nutritional formula and Diabetes specific enteral product in people with Type 2 Diabetes Mellitus, run by Abbott Nutrition at 1 site in United States.
Trial summary
Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes. Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed… 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?
- enteral nutritional formula and Diabetes specific enteral product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2007
- 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 form
- Type 2 diabetes
- 18 to 75 years of age
- Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
- If female is of childbearing potential, is practicing birth control
- BMI greater than or equal to 18.5 kg/m2 and less than 40.0 kg/m2
- Medications, such as antihyperglycemic or thyroid medications or hormone therapy, have been maintained at a constant dosage for at least two months prior to screening visit
Who cannot join
- Uses exogenous insulin for glucose control
- Type 1 diabetes
- History of diabetic ketoacidosis
- Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
- Active malignancy
- Significant cardiovascular event less than 12 weeks prior to study entry
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- End stage organ failure or is status post organ transplant
- Has an active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion excluding diabetes
- Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
- Taking any herbals, dietary supplements or medications, other than antihyperglycemic medications during the past four weeks that could profoundly affect blood glucose
- Fainted or experienced other adverse reactions in response to blood collection prior to this study
- Has clotting or bleeding disorders
- Allergic or intolerant to any ingredient found in the study products
- Participant in a concomitant trial that conflicts with this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Provident Clinical Research and Consulting, Inc.
Bloomington, Indiana, 47403
About this study
Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.
Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- enteral nutritional formula, Diabetes specific enteral 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.
enteral nutritional formulaOther
Meal glucose tolerance test
Diabetes specific enteral productOther
Meal Glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| #1 | Experimental | Diabetes specific enteral product Receives: Other: Diabetes specific enteral product |
| #2 | Active comparator | Standard enteral feeding Receives: Other: enteral nutritional formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive area under the curve (AUC) for plasma glucose and mean glucose level
Measured: 240 minutes
Secondary outcomes (1)
Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2007
- Study completionNov 2007
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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kevin C. Maki, PhD, Principal investigator, Provident Clinical Research and Consulting, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520065
- Sponsor's protocol ID
- BK06
- Status last verified
- Aug 2007
- First submitted
- 21 Aug 2007
- Last updated
- 4 Jul 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 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nutritional Products for People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00520065
- Acronym / sponsor ID
- BK06
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 23 Aug 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.
Part A: To compare the glucose and insulin responses of a standard tube feeding product to that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.
Part B: To compare the glucose response of a standard tube feeding product to that of a diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a sole source of nutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| #1 | Experimental | Other: Diabetes specific enteral productDiabetes specific enteral product |
| #2 | Active comparator | Other: enteral nutritional formulaStandard enteral feeding |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated informed consent form
- Type 2 diabetes
- 18 to 75 years of age
- Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
- If female is of childbearing potential, is practicing birth control
Key exclusion criteria (14 listed)
- Uses exogenous insulin for glucose control
- Type 1 diabetes
- History of diabetic ketoacidosis
- Current infection; has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks
- Active malignancy
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 |
|---|---|---|
| enteral nutritional formulaMeal glucose tolerance test | Other | #2 |
| Diabetes specific enteral productMeal Glucose tolerance test | Other | #1 |
Primary outcome
Positive area under the curve (AUC) for plasma glucose and mean glucose level
Time frame: 240 minutes
1 secondary outcome
Adjusted peak values for plasma glucose and serum insulin concentrations and positive AUC for serum insulin concentration
Time frame: 240 minutes
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 4 Jul 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.
Kevin C. Maki, PhD principal investigator
Provident Clinical Research and Consulting, 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 enteral nutritional formula and Diabetes specific enteral 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 7 inclusion and 14 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 4 Jul 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?
Positive area under the curve (AUC) for plasma glucose and mean glucose level (time frame: 240 minutes). 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 NCT00520065, 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 4 Jul 2008.