Diabetes Mellitus Type 2Phase 3NCT00540488
Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas
A Phase 3 study testing Adult enteral formula in people with Diabetes Mellitus Type 2, run by Abbott Nutrition at 2 sites in United States.
Trial summary
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Adult enteral formula
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2002to not given
- Phase
- Phase 3
- 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
- Adult, Older adult
Who may be able to join
- signed and dated informed consent
- 18-75 years of age
- history of type 2 diabetes
- males and non-pregnant, non-lactating females
Who cannot join
- subject uses insulin for glucose control
- significant cardiovascular event <12 weeks prior to study entry
- active malignancies
- history of end stage renal disease
- history of organ transplant
- current hepatic disease
Show all 11Show fewer
- intervention for HIB
- takes niacin
- history of gastroparesis
- active disease that may interfere with nutrient intake
- allergy or intolerance to ingredients in the study products
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, North Carolina, 29425
Protocare Trials, Chicago Center for Clinical Research
Chicago, Illinois, 60610
About this study
Official title: Randomized, Double Blind, Three Way Crossover Comparison of Glucose and Insulin Responses During a Meal Glucose Tolerance Test in Subjects With Type 2 Diabetes Consuming Disease-Specific Versus Standard Nutritional Formula
To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Adult enteral formula
- 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.
Adult enteral formulaOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted area under the curve (adj-AUC) of glucose response
Measured: 0-240 minutes
Secondary outcomes (1)
Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance
Measured: 0 - 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carolyn Alish, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540488
- Sponsor's protocol ID
- SRDB09
- Status last verified
- Oct 2007
- First submitted
- 5 Oct 2007
- Last updated
- 15 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Three Way Crossover Comparison of Glucose and Insulin Responses During a Meal Glucose Tolerance Test in Subjects With Type 2 Diabetes Consuming Disease-Specific Versus Standard Nutritional Formula
- ClinicalTrials.gov ID
- NCT00540488
- Acronym / sponsor ID
- SRDB09
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- First posted
- 8 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 measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- signed and dated informed consent
- 18-75 years of age
- history of type 2 diabetes
- males and non-pregnant, non-lactating females
Key exclusion criteria (11 listed)
- subject uses insulin for glucose control
- significant cardiovascular event <12 weeks prior to study entry
- active malignancies
- history of end stage renal disease
- history of organ transplant
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 |
|---|---|---|
| Adult enteral formula | Other | – |
Primary outcome
Adjusted area under the curve (adj-AUC) of glucose response
Time frame: 0-240 minutes
1 secondary outcome
Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance
Time frame: 0 - 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 15 Oct 2007.
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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.
Carolyn Alish, PhD study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adult enteral formula in people with Diabetes Mellitus Type 2, run by Abbott Nutrition 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 4 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 15 Oct 2007. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Adjusted area under the curve (adj-AUC) of glucose response (time frame: 0-240 minutes). 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 15 Oct 2007.