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

Abbott Nutrition5 sites in 2 countries251 target enrollmentAugust 26, 2020

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Abbott Nutrition
Enrollment: 251
Locations: 5
Primary Endpoint: HbA1c Level
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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: i) "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.

Registry

clinicaltrials.gov

Start Date

August 26, 2020

End Date

December 6, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:
•Condoms, sponge, diaphragm or intrauterine device;
•Oral or parenteral contraceptives for 3 months prior to Baseline Visit;
•Vasectomized partner;
•Total abstinence from sexual intercourse

Exclusion Criteria

•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
•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