Diabetes Mellitus, Type 2Phase 2/3NCT01326299
Post Prandial Glucose Control Proof-of-Principle
A Phase 2/3 study testing Nutritional ingredient, #1 Nutritional ingredient +Fiber and #2 Nutritional ingredient + Fiber in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 1 site in United States.
Trial summary
The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Nutritional ingredient, #1 Nutritional ingredient +Fiber and #2 Nutritional ingredient + Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2010
- Phase
- Phase 2/3
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- between 21 and 75 years of age
- male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
- BMI is > 18.5 kg/m2 and <35 kg/m2
- HbA1c < 9.0%
Who cannot join
- Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
- type 1 diabetes.
- history of diabetic ketoacidosis.
- current infection
- active malignancy
- has had a significant cardiovascular event or history of congestive heart failure.
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- end-stage organ failure or post organ transplant.
- history of renal disease.
- hepatic disease.
- history of gastrointestinal disorders
- chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
- clotting or bleeding disorders.
- allergic or intolerant to any ingredient found in the study products.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Carbohydrate placebo, Nutritional ingredient, #1 Nutritional ingredient +Fiber, #2 Nutritional ingredient + Fiber, #3 Nutritional ingredient + Fiber
- 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.
Carbohydrate placeboOther
dissolve in water and consume with meal
Nutritional ingredientOther
Dissolve in water and consume with meals
#1 Nutritional ingredient +FiberOther
Dissolve in water and consume with meal
#2 Nutritional ingredient + FiberOther
Dissolve in water and consume with meal
#3 Nutritional ingredient + FiberOther
Dissolve in water and consume with meal
| Study group | Role | What they receive |
|---|---|---|
| Nutritional ingredient | Active comparator | Dissolve in water and consume with meal Receives: Other: Nutritional ingredient |
| Carbohydrate | Placebo comparator | dissolve in water and consume with meal Receives: Other: Carbohydrate placebo |
| #1 Nutrtitional ingredient + Fiber | Experimental | Dissolve in water and consume with meal Receives: Other: #1 Nutritional ingredient +Fiber |
| #2 Nutritional ingredient + Fiber | Experimental | Dissolve in water and consume with meal Receives: Other: #2 Nutritional ingredient + Fiber |
| #3 Nutritional ingredient + Fiber | Experimental | Dissolve in water and consume with meal Receives: Other: #3 Nutritional ingredient + Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive AUC from 0 to 240 minutes for plasma glucose.
Measured: 0 to 240 minutes
Secondary outcomes (1)
Plasma glucose concentrations
Measured: 0 to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionSep 2010
- Study completionSep 2010
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amy Devitt-Maicher, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326299
- Sponsor's protocol ID
- BK92
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Prandial Glucose Control Proof-of-Principle
- ClinicalTrials.gov ID
- NCT01326299
- Acronym / sponsor ID
- BK92
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Mar 2011 (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.
The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nutritional ingredient | Active comparator | Other: Nutritional ingredientDissolve in water and consume with meal |
| Carbohydrate | Placebo comparator | Other: Carbohydrate placebodissolve in water and consume with meal |
| #1 Nutrtitional ingredient + Fiber | Experimental | Other: #1 Nutritional ingredient +FiberDissolve in water and consume with meal |
| #2 Nutritional ingredient + Fiber | Experimental | Other: #2 Nutritional ingredient + FiberDissolve in water and consume with meal |
| #3 Nutritional ingredient + Fiber | Experimental | Other: #3 Nutritional ingredient + FiberDissolve in water and consume with meal |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- type 2 diabetes
- between 21 and 75 years of age
- male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
- BMI is > 18.5 kg/m2 and <35 kg/m2
- HbA1c < 9.0%
Key exclusion criteria (14 listed)
- Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
- type 1 diabetes.
- history of diabetic ketoacidosis.
- current infection
- 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 |
|---|---|---|
| Carbohydrate placebodissolve in water and consume with meal | Other | Carbohydrate |
| Nutritional ingredientDissolve in water and consume with meals | Other | Nutritional ingredient |
| #1 Nutritional ingredient +FiberDissolve in water and consume with meal | Other | #1 Nutrtitional ingredient + Fiber |
| #2 Nutritional ingredient + FiberDissolve in water and consume with meal | Other | #2 Nutritional ingredient + Fiber |
| #3 Nutritional ingredient + FiberDissolve in water and consume with meal | Other | #3 Nutritional ingredient + Fiber |
Primary outcome
Positive AUC from 0 to 240 minutes for plasma glucose.
Time frame: 0 to 240 minutes
1 secondary outcome
Plasma glucose concentrations
Time frame: 0 to 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 30 Mar 2011.
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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.
Amy Devitt-Maicher, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nutritional ingredient, #1 Nutritional ingredient +Fiber and #2 Nutritional ingredient + Fiber in people with Diabetes Mellitus, Type 2, 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 5 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 30 Mar 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Positive AUC from 0 to 240 minutes for plasma glucose. (time frame: 0 to 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 30 Mar 2011.