Diabetes Mellitus, Type 2Phase 3NCT01188200
Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes
A Phase 3 study testing Experimental nutritional formula #M979 and Standard food in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 11 sites in Russia.
Trial summary
The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Experimental nutritional formula #M979 and Standard food
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 11 sitesRussia
- Study dates
- Dec 2009to Jun 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has type 2 diabetes.
- Subject is over 18 years of age.
- Subject is a male, or a non-pregnant, non-lactating female.
- Subject's BMI is > 20 kg/m2 and < 40 kg/m2.
- Subject's HbA1c level is 6.5 - 11%.
- If on a chronic thyroid medication or hormone replacement therapy, subject has been on constant dosage for at least two months prior to Screening Visit.
- Subject's weight is stable for the past two months prior to Screening Visit.
Who cannot join
- Subject uses exogenous insulin, Byetta or alpha-glucosidase inhibitor for glucose control.
- Subject has type 1 diabetes.
- Subject has history of diabetic ketoacidosis.
- Subject has the following: current infection ; has had inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or antibiotics in the last 3 weeks prior to screening.
- Subject has an active malignancy.
- Subject has had significant cardiovascular event <6 months prior to study entry or history of congestive heart failure.
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- Subject has end stage organ failure.
- Subject has history of severe gastroparesis, renal or hepatic disease.
- Subject has an active metabolic, hepatic, or gastrointestinal disease or condition that may interfere with nutrient absorption, distribution, metabolism, or excretion, excluding diabetes.
- Subject has a chronic, contagious, infectious disease.
- Taking daily medications at doses that would interfere with nutrient absorption, metabolism, excretion, gastric motility, or blood glucose.
- Subject has fainted or experienced other adverse event in response to blood collection prior to enrollment into this study.
- Clotting or bleeding disorders.
- Allergic or intolerant to any ingredient found in the test meal.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
Kuban State Medical University
Krasnodar, 350043
City Clinical Hospital #68
Moscow, 109263
City Clinical Hospital #52
Moscow, 123182
City Hospital #67
Moscow, 123423
Novosibirsk State Medical University
Novosibirsk, 630047
State Novosibirsk Regional Hospital
Novosibirsk, 630087
City Clinical Hospital #3
Saint Petersburg, 195257
Medical Centre Twenty First Century
Saint Petersburgh, 190068
Diabetes Centre, LLC
Samara, 443046
Tyumen State Medical Academy
Tyumen, 625023
Bashkir State Medical University
Ufa, 450071
About this study
The purpose of this study is to demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Experimental nutritional formula #M979, Standard 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.
Experimental nutritional formula #M979Other
One two hundred and forty mL serving at test time, taken orally
Standard foodOther
Standard meal prior to test time
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Formula #M979 | Experimental | nutritional formula Receives: Other: Experimental nutritional formula #M979 |
| Regular standard meal | Active comparator | standard meal Receives: Other: Standard food |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable is glucose concentration
Measured: 0 to 240 minutes
Secondary outcomes (1)
Additional measures of glucose concentration
Measured: 0 to 240 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionJun 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anne Voss, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188200
- Sponsor's protocol ID
- BK79
- Status last verified
- Jul 2010
- First submitted
- 24 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-Hour Evaluation of a Medical Food in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01188200
- Acronym / sponsor ID
- BK79
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Aug 2010 (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 demonstrate the efficacy of a nutritional formula in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Formula #M979 | Experimental | Other: Experimental nutritional formula #M979nutritional formula |
| Regular standard meal | Active comparator | Other: Standard foodstandard meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has type 2 diabetes.
- Subject is over 18 years of age.
- Subject is a male, or a non-pregnant, non-lactating female.
- Subject's BMI is > 20 kg/m2 and < 40 kg/m2.
- Subject's HbA1c level is 6.5 - 11%.
Key exclusion criteria (14 listed)
- Subject uses exogenous insulin, Byetta or alpha-glucosidase inhibitor for glucose control.
- Subject has type 1 diabetes.
- Subject has history of diabetic ketoacidosis.
- Subject has the following: current infection ; has had inpatient surgery or received systemic corticosteroid treatment in the last 3 months; or antibiotics in the last 3 weeks prior to screening.
- Subject has an 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 |
|---|---|---|
| Experimental nutritional formula #M979One two hundred and forty mL serving at test time, taken orally | Other | Nutritional Formula #M979 |
| Standard foodStandard meal prior to test time | Other | Regular standard meal |
Primary outcome
The primary variable is glucose concentration
Time frame: 0 to 240 minutes
1 secondary outcome
Additional measures of glucose concentration
Time frame: 0 to 240 mins
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 25 Aug 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.
Anne Voss, PhD study chair
Abbott Nutrition
11 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 Experimental nutritional formula #M979 and Standard food in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 11 sites in Russia.
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 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. 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?
The primary variable is glucose concentration (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 25 Aug 2010.