Diabetes Mellitus, Type 2Phase 3NCT00797069
Comparison of Nutritional Products for People With Type 2 Diabetes
A Phase 3 study testing standard nutritional product (medical food), nutritional product for diabetes (medical food) and diabetes specific experimental nutritional product (medical food) in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 3 sites in Spain.
Trial summary
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes. 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?
- standard nutritional product (medical food), nutritional product for diabetes (medical food) and diabetes specific experimental nutritional product (medical food)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2008to Jul 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
- Subject is between 18 and 75 years of age, inclusive.
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- If female is of childbearing potential, is practicing a method of birth control.
- Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2.
- If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
Who cannot join
- Subject uses exogenous insulin for glucose control.
- Subject states that he/she has type 1 diabetes.
- Subject states that he/she has a history of diabetic ketoacidosis.
- Subject takes an alpha-glucosidase inhibitor.
- Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
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- Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- Subject states that he/she has end stage organ failure or is status post organ transplant.
- Subject states that he/she has a history of renal disease.
- Subject states that he/she has current hepatic disease.
- Subject states that he/she has a history of severe gastroparesis.
- Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
- Subject states that he/she has clotting or bleeding disorders.
- Subject is known to be allergic or intolerant to any ingredient found in the study products.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- standard nutritional product (medical food), nutritional product for diabetes (medical food), diabetes specific experimental nutritional product (medical food)
- 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 nutritional product (medical food)Other
once during crossover
nutritional product for diabetes (medical food)Other
once during crossover
diabetes specific experimental nutritional product (medical food)Other
once during crossover
| Study group | Role | What they receive |
|---|---|---|
| standard nutritional product | Active comparator | Standard nutritional product not specific for diabetes Receives: Other: standard nutritional product (medical food) |
| diabetes specific product | Active comparator | Diabetes specific nutritional product Receives: Other: nutritional product for diabetes (medical food) |
| Experimental diabetes specific product | Experimental | Diabetes specific experimental nutritional product Receives: Other: diabetes specific experimental nutritional product (medical food) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
Measured: Three crossover periods
Secondary outcomes (1)
To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
Measured: Three crossover periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionJul 2009
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jennifer Williams, MS, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797069
- Sponsor's protocol ID
- BK20
- Status last verified
- Mar 2010
- First submitted
- 23 Nov 2008
- Last updated
- 30 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. 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
- NCT00797069
- Acronym / sponsor ID
- BK20
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Nov 2008 (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.
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard nutritional product | Active comparator | Other: standard nutritional product (medical food)Standard nutritional product not specific for diabetes |
| diabetes specific product | Active comparator | Other: nutritional product for diabetes (medical food)Diabetes specific nutritional product |
| Experimental diabetes specific product | Experimental | Other: diabetes specific experimental nutritional product (medical food)Diabetes specific experimental nutritional product |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
- Subject is between 18 and 75 years of age, inclusive.
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- If female is of childbearing potential, is practicing a method of birth control.
- Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2.
Key exclusion criteria (15 listed)
- Subject uses exogenous insulin for glucose control.
- Subject states that he/she has type 1 diabetes.
- Subject states that he/she has a history of diabetic ketoacidosis.
- Subject takes an alpha-glucosidase inhibitor.
- Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
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 nutritional product (medical food)once during crossover | Other | standard nutritional product |
| nutritional product for diabetes (medical food)once during crossover | Other | diabetes specific product |
| diabetes specific experimental nutritional product (medical food)once during crossover | Other | Experimental diabetes specific product |
Primary outcome
To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
Time frame: Three crossover periods
1 secondary outcome
To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
Time frame: Three crossover periods
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 30 Jul 2010.
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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.
Jennifer Williams, MS study chair
Abbott Nutrition
3 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 standard nutritional product (medical food), nutritional product for diabetes (medical food) and diabetes specific experimental nutritional product (medical food) in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 3 sites in Spain.
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 15 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 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products. (time frame: Three crossover periods). 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 30 Jul 2010.