Diabetes Mellitus, Type 2NCT04168541
Glycemic Response in Persons With Type 2 Diabetes Mellitus
A study testing Oral Nutrition Supplement in people with Diabetes Mellitus, Type 2, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Oral Nutrition Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 18 Apr 2018
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Subject inclusion criteria
All subjects must comply with all the following inclusion criteria:
- Age 20-75 years
- Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
- Hemoglobin A1C less than 9.0%
- Fasting blood glucose less than 180 mg
- Hematocrit levels within normal limits
- Having obtained his/her informed consent
Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.
- Abnormal thyroid function
- Creatinine >2.0 mg/dl
- Potassium <3.5 mEq/l
- Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
- Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
- Unable to give informed consent or follow instructions
- Current insulin therapy or insulin therapy within the past month
- Patient who are pregnant
- Allergies to milk, soy or any component of the test product
- Patient who in the investigators assessment cannot be expected to comply with treatment
- Currently participating or having participated in another clinical trial
- Patients with anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
Official title: Plasma Glucose and Insulin Response to Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Oral Nutrition Supplement
- 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.
Oral Nutrition SupplementOther
Product intake of oral nutrition supplement provided
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutrition Supplement A | Active comparator | Product containing calories from carbohydrate, protein, and fat Receives: Other: Oral Nutrition Supplement |
| Oral Nutrition Supplement B | Active comparator | Product containing calories from carbohydrate, protein, and fat Receives: Other: Oral Nutrition Supplement |
| Oral Nutrition Supplement C | Active comparator | Product containing calories from carbohydrate, protein, and fat Receives: Other: Oral Nutrition Supplement |
| Oral Nutrition Supplement D | Active comparator | Product containing calories from carbohydrate, protein, and fat Receives: Other: Oral Nutrition Supplement |
| Oral Nutrition Supplement E | Active comparator | Product containing calories from carbohydrate, protein, and fat Receives: Other: Oral Nutrition Supplement |
| Oral Nutrition Supplement F | Active comparator | Product containing calories from carbohydrate, protein, and fat Receives: Other: Oral Nutrition Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the blood glucose curve (ACU 0-240 minutes)
Measured: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes (2)
Area under the insulin curves (AUC 0-240)
Measured: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index [Change in Ins30/Change in Glu30]
Measured: [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start5 Feb 2018
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
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.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Neutel, MD, Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168541
- Sponsor's protocol ID
- 17.11.US.HCN
- Status last verified
- Nov 2019
- First submitted
- 1 Feb 2018
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Glucose and Insulin Response to Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04168541
- Acronym / sponsor ID
- 17.11.US.HCN
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 19 Nov 2019 (actual)
- 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.
This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
| Arm | Type | Receives |
|---|---|---|
| Oral Nutrition Supplement A | Active comparator | Other: Oral Nutrition SupplementProduct containing calories from carbohydrate, protein, and fat |
| Oral Nutrition Supplement B | Active comparator | Other: Oral Nutrition SupplementProduct containing calories from carbohydrate, protein, and fat |
| Oral Nutrition Supplement C | Active comparator | Other: Oral Nutrition SupplementProduct containing calories from carbohydrate, protein, and fat |
| Oral Nutrition Supplement D | Active comparator | Other: Oral Nutrition SupplementProduct containing calories from carbohydrate, protein, and fat |
| Oral Nutrition Supplement E | Active comparator | Other: Oral Nutrition SupplementProduct containing calories from carbohydrate, protein, and fat |
| Oral Nutrition Supplement F | Active comparator | Other: Oral Nutrition SupplementProduct containing calories from carbohydrate, protein, and fat |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Oral Nutrition SupplementProduct intake of oral nutrition supplement provided | Other | Oral Nutrition Supplement A, Oral Nutrition Supplement B, Oral Nutrition Supplement C, Oral Nutrition Supplement D, Oral Nutrition Supplement E, Oral Nutrition Supplement F |
Primary outcome
Area under the blood glucose curve (ACU 0-240 minutes)
Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
2 secondary outcomes
Area under the insulin curves (AUC 0-240)
Time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index [Change in Ins30/Change in Glu30]
Time frame: [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 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 May 2025.
- Individual participant dataSharing planned: No
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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.
Joel Neutel, MD principal investigator
Orange County Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutrition Supplement in people with Diabetes Mellitus, Type 2, run by Société des Produits Nestlé (SPN) 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?
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 May 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Area under the blood glucose curve (ACU 0-240 minutes) (time frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 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 May 2025.