Type 2 Diabetes MellitusNCT02248714

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

A study testing Glucerna SR in people with Type 2 Diabetes Mellitus, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.

Completed

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

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Glucerna SR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: 1 siteChina
Study dates: Mar 2014to Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 200023

Other trials in China

About this study

Official title: A 4-week, Single-center, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy of Glucerna SR Using Continuous Glucose Monitoring System(CGMS) in Chinese Drug-naïve Subjects With Type 2 Diabetes

Read the detailed description

Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response. About 24% of the total energy provided by Glucerna SR is due to monounsaturated fatty acids, which can help keep good metabolic state in accordance with the recommendations of the American Heart Association. The aim 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 consumed as a meal replacement at breakfast meal on daily and day-to-day amplitude of blood glucose fluctuation.

Conditions: Type 2 Diabetes Mellitus
Being tested: Glucerna SR
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.

Glucerna SRDietary supplement
Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.

Study groups in NCT02248714
Study group	Role	What they receive
Study arm	Experimental	Use Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.) Receives: Dietary Supplement: Glucerna SR
Control arm	No intervention	Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.

What is being measured

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

Change From Baseline in AUCpp
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal.
Measured: 4 weeks
Change From Baseline in SDBG
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data.
Measured: 4 weeks
Change From Baseline in MAGE
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data.
Measured: 4 weeks
Change From Baseline in Glucose Coefficient of Variation(CV)
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.
Measured: 4 weeks

Secondary outcomes (12)

Change From Baseline in BMI
the change of BMI between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in Systolic Blood Pressure
the change of systolic blood pressure between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in Diastolic Blood Pressure
the change of diastolic blood pressure between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in TC
the change of total cholesterol between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in Triglycerides
the change of triglycerides between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in HDL-c
the change of HDL-c between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in LDL-c
the change of LDL-c between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in FPG
the change of FPG between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in 2h-PG
the change of 2h-PG between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in HbA1c
the change of HbA1c between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in GA
the change of GA between the end and the beginning of the study
Measured: 4 weeks
Change From Baseline in HOMA-IR
the change of HOMA-IR between the end and the beginning of the study
Measured: 4 weeks

Timeline

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

Mar 2014Dec 2018

First posted25 Sep 2014 (estimated)
Study startMar 2014
Primary completionJun 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02248714
Sponsor's protocol ID: 2010-32
Status last verified: Apr 2019
First submitted: 23 Sep 2014
Last updated: 1 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-week, Single-center, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy of Glucerna SR Using Continuous Glucose Monitoring System(CGMS) in Chinese Drug-naïve Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02248714
Acronym / sponsor ID: 2010-32
Conditions: Type 2 Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
Study start: Mar 2014
Primary completion: Jun 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 25 Sep 2014 (estimated)
Results: Posted 1 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Study arm	Experimental	Dietary Supplement: Glucerna SRUse Glucerna SR as a meal replacement at breakfast meal in the study group, meanwhile patients receive diabetes diet management (Each subject will be individually instructed by a dedicating dietitian how to implement the daily diabetes diet before starting the study.)
Control arm	No intervention	–Patients only receive diabetes diet management according to the instruction of dedicating dietitian on how to implement the daily diabetes diet.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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)

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
Glucerna SRGlucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.	Dietary supplement	Study arm

Primary outcome

Change From Baseline in AUCpp
Time frame: 4 weeks
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal.
Change From Baseline in SDBG
Time frame: 4 weeks
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data.
Change From Baseline in MAGE
Time frame: 4 weeks
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data.
Change From Baseline in Glucose Coefficient of Variation(CV)
Time frame: 4 weeks
Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.

12 secondary outcomes

Change From Baseline in BMI
Time frame: 4 weeks
Change From Baseline in Systolic Blood Pressure
Time frame: 4 weeks
Change From Baseline in Diastolic Blood Pressure
Time frame: 4 weeks
Change From Baseline in TC
Time frame: 4 weeks
Change From Baseline in Triglycerides
Time frame: 4 weeks
Change From Baseline in HDL-c
Time frame: 4 weeks
Change From Baseline in LDL-c
Time frame: 4 weeks
Change From Baseline in FPG
Time frame: 4 weeks
Change From Baseline in 2h-PG
Time frame: 4 weeks
Change From Baseline in HbA1c
Time frame: 4 weeks
Change From Baseline in GA
Time frame: 4 weeks
Change From Baseline in HOMA-IR
Time frame: 4 weeks

Results and safety

Results posted to the registry on 1 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Arm	66	62
Control Arm	65	61

Primary outcome: Change From Baseline in AUCpp

Time frame: 4 weeks. Mean (Standard Deviation). Unit: min*mmol/L

Measure	Study Arm n = 62	Control Arm n = 61
Value	-287.8 (368.7)	-31.2 (301.6)

Population analysed: The analysis population is subjects who completed the whole study.

Primary outcome: Change From Baseline in SDBG

Time frame: 4 weeks. Mean (Standard Deviation). Unit: mmol/L

Measure	Study Arm n = 62	Control Arm n = 61
Value	-0.6 (0.8)	-0.2 (0.7)

Population analysed: The analysis population is subjects who completed the whole study.

Primary outcome: Change From Baseline in MAGE

Time frame: 4 weeks. Mean (Standard Deviation). Unit: mmol/L

Measure	Study Arm n = 62	Control Arm n = 61
Value	-1.6 (2.3)	-0.6 (2.1)

Population analysed: The analysis population is subjects who completed the whole study.

Primary outcome: Change From Baseline in Glucose Coefficient of Variation(CV)

Time frame: 4 weeks. Mean (Standard Deviation). Unit: percentage of CV

Measure	Study Arm n = 62	Control Arm n = 61
Value	-4.7 (8.1)	-0.2 (7.6)

Population analysed: The analysis population is subjects who completed the whole study.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Arm	0 of 66 (0%)	0 of 66 (0%)	0 of 66
Control Arm	0 of 65 (0%)	0 of 65 (0%)	0 of 65

Limitations and caveats (from the sponsor): 1.The intervention period was relatively short. 2. The open-label design of the current study may introduce some extent of bias. 3.Only untreated T2D patients were admitted in the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

Yuqian Bao, MD principal investigator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Glucerna SR in people with Type 2 Diabetes Mellitus, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.

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 4 inclusion and 8 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 1 Jul 2019. 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 China. 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?

Yes. Results are posted in the registry (first posted 1 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in AUCpp (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 NCT02248714.

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 1 Jul 2019.