N/A N=131 Randomized Treatment

The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT02248714 ↗

Enrolled (actual)

131

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Change From Baseline in AUCpp — -287.8; -31.2 min*mmol/L

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Glucerna SR (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in AUCpp	-287.8; -31.2	—
PRIMARY Change From Baseline in SDBG	-0.6; -0.2	—
PRIMARY Change From Baseline in MAGE	-1.6; -0.6	—
PRIMARY Change From Baseline in Glucose Coefficient of Variation(CV)	-4.7; -0.2	—
SECONDARY Change From Baseline in BMI	-0.5; -0.5	—
SECONDARY Change From Baseline in Systolic Blood Pressure	-7.5; -2.8	—
SECONDARY Change From Baseline in Diastolic Blood Pressure	-4.4; -1.1	—
SECONDARY Change From Baseline in TC	-0.1; -0.2	—
SECONDARY Change From Baseline in Triglycerides	-0.4; -0.2	—
SECONDARY Change From Baseline in HDL-c	-0.0; 0.0	—
SECONDARY Change From Baseline in LDL-c	-0.1; -0.1	—
SECONDARY Change From Baseline in FPG	-0.7; -0.6	—
SECONDARY Change From Baseline in 2h-PG	-2.9; -2.0	—
SECONDARY Change From Baseline in HbA1c	-0.5; -0.5	—
SECONDARY Change From Baseline in GA	-2.3; -1.8	—
SECONDARY Change From Baseline in HOMA-IR	-1.3; -1.0	—

Summary

The purpose of the study is to evaluate the effect of Glucerna SR treating newly-diagnosed type 2 diabetes patients (NDM) on glycemic stability, with the application of CGMS (continuous glucose monitoring system) and to further realize the safety and effect of Glucerna SR on daily and day-to-day amplitude of blood glucose fluctuation.

Eligibility Criteria

Inclusion Criteria

Newly diagnosed type 2 diabetes mellitus
FPG≤13mmol/l and/or 2hPG≤18mmol/l
HbA1c≥7.0%
BMI (Body Mass Index)≥18.5kg/m2

Exclusion Criteria

Patients taking any class of injectible or oral hypoglycemia agents to manage their hyperglycemia.
Female patients are in gestation, lactation or intend to be pregnant in the study period.
Patients are with type 1 diabetes, or other special types of diabetes, or gestational diabetes mellitus.
Patients with drug hypersensitivity.
Patients with obvious hepatic or renal diseases (ALT, T-Bil>1.5 times of upper limit)
Patients with severe or unstable angina, or heart failure (NYHA class III/IV)
Patients having acute complications, or chronic complications maintained insulin therapy or insulin therapy under stress.
Patients with chronic consumptive diseases like cerebrovascular disease, tumor, tuberculosis, or hematopathy, psychosis, autoimmune disease or severe digestive dysfunction.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02248714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.