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Diabetes Mellitus, Type 2NCT04345497

Diabetes-Specific Formula on Long Term Glycemic Control

A study testing Diabetes-Specific Formula in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aims to investigate the effect of a diabetes-specific formula (DSF) used as a (partial) meal replacement on long-term glycemic control and short-term glycemic variability in individuals with type 2 diabetes. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Diabetes-Specific Formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
5 sitesin 2 countries
Study dates
26 Aug 2020to 6 Dec 2022
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 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants (≥ 21 and ≤ 65 years of age)
  • Has type 2 diabetes as evidenced with oral anti-diabetic drug(s) at constant dose for at least two months prior to the study and is able to maintain number of medications, type and dose throughout the duration of the study
  • BMI ≥ 23 and < 35.0 kg/m2
  • Weight is stable (has maintained current body weight within 3 kg) for the two months prior to the Baseline Visit
  • Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit. A urine pregnancy test is required for all female participants unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to the Baseline Visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  • If the female is of childbearing potential, she is practicing one of the following methods of birth control and will continue through the duration of the study:
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  • Condoms, sponge, diaphragm or intrauterine device;
  • Oral or parenteral contraceptives for 3 months prior to Baseline Visit;
  • Vasectomized partner;
  • Total abstinence from sexual intercourse
  • If on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, the medication number, type and dose were constant for at least two months prior to the Baseline Visit and will continue through the duration of the study
  • Willingness to follow the protocol as described, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study
  • At least a two-week washout period is needed between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study
  • The participant is willing to refrain from taking non-study diabetes-specific formulas over the entire course of the study

Who cannot join

  • Screening HbA1c level <7% or ≥ 10%
  • Use of exogenous insulin for glucose control
  • Confirmed type 1 diabetes and/or had a history of diabetic ketoacidosis
  • Current infection (requiring medication), inpatient surgery or received systemic corticosteroid treatment [except for inhaled (includes nasal), topical, and ophthalmic steroids] in the last 3 months; or received antibiotics in the last 3 weeks
  • Active malignancy within the last 5 years
  • A significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure
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  • End-stage organ failure (such as end-stage renal disease) or is post-organ transplant
  • Current or history of renal disease or on dialysis or severe gastroparesis
  • Current hepatic disease
  • Has had bariatric surgery including gastric balloon; the history of gastrointestinal disease (e.g., Crohn's, colitis, celiac) or intestinal surgery that can interfere with consumption or digestion or absorption of study product
  • A chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV
  • Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the principal investigator or study physician
  • Taking any herbals, dietary supplements, or medications during the past four weeks prior to Baseline Visit that could profoundly affect (in the opinion of the primary investigator) blood glucose or appetite (e.g. orlistat, contrive, qsymia, belviq, incretins, cannabis, glucocorticoids, nicotinic acid, etc.) per healthcare professional's opinion
  • Using diabetes-specific formula(s), (e.g. Glucerna, Nestle Nutren Diabetes, Kalbe Diabetasol, Appeton Nutrition Wellness 60+ Diabetic, ForSure, Penta Sure DM, Resurge DM, Diben, Diasip, etc.) defined as more than one eating occasion per week within the past 3 months (those users who have stopped using such products for more than 3 months may not be excluded)
  • Clotting or bleeding disorders (the use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws will be allowed)
  • Has blood or blood-related diseases (e.g. hemophilia, thalassemia, sickle cell disease, hereditary spherocytosis, glucose-6-phosphate dehydrogenase deficiency)
  • Received a blood transfusion within the last 3 weeks
  • Allergic or intolerant to any ingredient found in the test meals
  • Participates in another study that has not been approved as a concomitant study by Abbott Nutrition
  • The participant has skin lesions hyperhidrosis, eczema, psoriasis, scarring, tattoos, redness, infection or edema at the application sites that in the opinion of the study investigator or study physician could interfere with device placement or the accuracy of interstitial glucose measurements.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Malaysia3 sites

  • International Medical University

    Kuala Lumpur, 57000

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

  • Klinik Kesihatan Seremban

    Seremban, 70300

Other trials in Malaysia

Thailand2 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Rajavithi Hospital

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: A Randomized Controlled Trial to Determine the Effects of a Diabetes-specific Formula on Long-term Glycemic Control and Short-term Glycemic Variability in Individuals With Type 2 Diabetes

The study aims to investigate the effect of a diabetes-specific formula (DSF) used as a (partial) meal replacement on long-term glycemic control and short-term glycemic variability in individuals with type 2 diabetes.

Read the detailed description

This is a randomized, controlled, parallel study. Eligible participants will be randomly allocated (at 1 :1 ratio) to one of two groups: DSF group or control group.The total expected duration of the study is 97 days.

There are two periods in the study:

  1. "Run-in Period" (Study Days -6 to -1): participants will wear the CGMS:Continuous Glucose Monitoring System (FreeStyle Libre Pro) and will be asked to follow and track their diet and physical activity on a daily basis. ii) "Intervention Period" (Study Days 0 to 90): participants will be randomized into one of the two groups (n = 125 per group): DSF group or control group.
Being tested
Diabetes-Specific Formula, Standard Of Care
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.

  • Diabetes-Specific FormulaOther

    Diabetes-Specific Formula and Standard of Care

  • Standard Of CareOther

    Standard of Care

Study groups in NCT04345497
Study groupRoleWhat they receive
Diabetes-Specific FormulaExperimentalDiabetes-specific formula 1-2 servings a day and Standard of Care
Receives: Other: Diabetes-Specific Formula
Standard of CareOtherStandard of Care
Receives: Other: Standard Of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c Level

    Change in HbA1c level from Day 0 to Day 90

    Measured: Study Days 0, 45 and 90

Secondary outcomes (5)

  1. Glycemic Excursion

    Mean Amplitude of Glycemic Excursions (MAGE)

    Measured: Study Day 1 to Day 7

  2. Glucose

    Mean and coefficient of variation (CV) of glucose during the intervention phase

    Measured: Study Day 1 to Day 7

  3. Time of glucose level

    Time of glucose level in target, below and above range per day during intervention phase

    Measured: Study Day 1 to Day 7

  4. Hypoglycemic Episodes

    Number of hypoglycemic episodes per day during the intervention phase

    Measured: Study Day 1 to Day 7

  5. Hyperglycemic Episodes

    Number of hyperglycemic episodes per day during the intervention phase

    Measured: Study Day 1 to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2020
  2. Study start26 Aug 2020
  3. Primary completion6 Dec 2022
  4. Study completion6 Dec 2022

Resources

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
Parallel groups
Model description
Determine the effects of a diabetes-specific formula \[1-2 servings per day as a (partial) meal replacement\] in addition to standard of care on HbA1c level, in comparison with the standard of care only
Masking
None (open label)
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04345497
Sponsor's protocol ID
BL46
Status last verified
Feb 2023
First submitted
10 Apr 2020
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes-Specific Formula in people with Diabetes Mellitus, Type 2, run by Abbott Nutrition at 5 sites in 2 countries.

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 14 inclusion and 20 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Malaysia, Thailand. 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?

HbA1c Level (time frame: Study Days 0, 45 and 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345497.

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 14 Feb 2023.

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