Diabetes Mellitus, Type 2Phase 3NCT00753181
Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes
A Phase 3 study testing Nutritional Formula, Usual diet and Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars. in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 2 sites in United States.
Trial summary
To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet. 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?
- Nutritional Formula, Usual diet and Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Mar 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
- type 2 diabetes
- HbA1c >6.5% and <11.0%
- male/non-pregnant, non-lactating female, at least 6 months postpartum
- if female of childbearing potential, practicing method of birth control
- Body Mass Index > 18.5 kg/m2 and < 43.0 kg/m2.
- weight stable for past two months
- if on anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, dosage constant for at least two months
Who cannot join
- uses injected medications (e.g., insulin, exenatide) for glucose control.
- history of diabetic ketoacidosis
- current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
- active malignancy
- states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
- end stage organ failure
Show all 14Show fewer
- active metabolic, hepatic, or gastrointestinal disease that may interfere with nutrient absorption, distribution, metabolism, or excretion (such as gastroparesis), excluding diabetes.
- chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- use of herbals, dietary supplements, or medications, other than allowed medications, during past four weeks that could profoundly affect blood glucose.
- symptomatic in response to blood collection prior to enrollment into this study.
- clotting or bleeding disorders.
- non-typical eating pattern
- is currently using diabetes-specific nutritional product(s)defined as more than one eating occasion per week.
- engages in strenuous exercise five or more times per week.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Provident Clinical Research
Bloomington, Indiana, 47403
Radiant Research
Cincinnati, Ohio, 45242
About this study
To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Nutritional Formula, Usual diet, Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.
- 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.
Nutritional FormulaOther
nutritional shake daily
Usual dietOther
usual dietary habits
Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.Other
nutritional shake, diabetes specific cereal and diabetes snack bar daily
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Diabetes Meal Plan with Experimental Diabetes-Specific nutritional shake Receives: Other: Nutritional Formula |
| A2 | Active comparator | Usual diet Receives: Other: Usual diet |
| A3 | Experimental | Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars. Receives: Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily blood glucose level
Measured: 11 days
Secondary outcomes (1)
Percentage of time in specified glucose ranges; Glycemic excursions; Change in plasma glucose, insulin, free fatty acids, triglycerides, 1,5-anhydroglucitol, and fructosamine; Dietary intake variables
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionMar 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vikkie Mustad, PhD, Study director, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753181
- Sponsor's protocol ID
- BK21
- Status last verified
- Apr 2009
- First submitted
- 12 Sep 2008
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00753181
- Acronym / sponsor ID
- BK21
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Sep 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.
To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal Plan including Diabetes-Specific products compared to average daily blood glucose in subjects following their usual diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Other: Nutritional FormulaDiabetes Meal Plan with Experimental Diabetes-Specific nutritional shake |
| A2 | Active comparator | Other: Usual dietUsual diet |
| A3 | Experimental | Other: Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.Diabetes Meal Plan with Experimental Diabetes-Specific Nutritional Shake, diabetes specific Cereal, and diabetes specific snack bars. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- type 2 diabetes
- HbA1c >6.5% and <11.0%
- male/non-pregnant, non-lactating female, at least 6 months postpartum
- if female of childbearing potential, practicing method of birth control
- Body Mass Index > 18.5 kg/m2 and < 43.0 kg/m2.
Key exclusion criteria (14 listed)
- uses injected medications (e.g., insulin, exenatide) for glucose control.
- history of diabetic ketoacidosis
- current infection ; inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks
- active malignancy
- states he/she has had a significant cardiovascular event < 12 weeks prior to study entry or history of congestive heart failure in the last 12 months.
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 |
|---|---|---|
| Nutritional Formulanutritional shake daily | Other | A1 |
| Usual dietusual dietary habits | Other | A2 |
| Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.nutritional shake, diabetes specific cereal and diabetes snack bar daily | Other | A3 |
Primary outcome
Average daily blood glucose level
Time frame: 11 days
1 secondary outcome
Percentage of time in specified glucose ranges; Glycemic excursions; Change in plasma glucose, insulin, free fatty acids, triglycerides, 1,5-anhydroglucitol, and fructosamine; Dietary intake variables
Time frame: 11 days
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 27 Apr 2009.
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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.
Vikkie Mustad, PhD study director
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 Nutritional Formula, Usual diet and Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars. 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 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 27 Apr 2009. 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?
Average daily blood glucose level (time frame: 11 days). 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 27 Apr 2009.