Type 2 DiabetesNCT00631774
A Study to Evaluate the Postprandial Metabolic Response After Use of Glucerna SR in Obese Type 2 Diabetes
A study testing Glucerna SR in people with Type 2 Diabetes and Obesity, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This is a phase 4, 24-week, randomized, parallel, open-label study of a meal replacement program with Glucerna SR in obese Asian participants with type 2 diabetes. The duration of each subject's participation will be approximately 28 weeks, including a lead-in period of 2 weeks and a 2-week post-treatment telephone… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Glucerna SR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2007to Jan 2009
- 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
Who may be able to join
- Asians
- Diagnosed type 2 diabetes
- BMI between 25 and 40 kgm2
- Aged between 20 and 75 years old
- Current HbA1c between 6.0 and 8.5 percents
- Men and non-pregnant women. If woman, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control-condoms, sponge, foams, jellies, diaphragm or intrauterine device or on contraceptives for the 3-month period prior to Screening-a vasectomized partner-total abstinence from sexual intercourse. If woman, the results of a urine pregnancy test performed at Screening are negative. If woman, subject is not breast-feeding
- Subject is able and willing to replace breakfast and one snack before bed with Glucerna SR
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board or Independent Ethics Committee, prior to undertaking any study-specific procedures
Who cannot join
- History or evidence of type 1 diabetes
- Screening fasting glucose greater than 240 mgdL
- Treatment with insulin, alpha-glucosidase inhibitor, incretin mimetics, or DPP-IV inhibitors in the past 8 weeks
- History of severe hypoglycemia in the past 12 weeks
- History of severe diabetes complications e.g. amputation, blindness, diabetic coma
- Stated history of severe gastroparesis
Show all 21Show fewer
- Stated significant cardiovascular event e.g., myocardial infarction, stroke within 6 weeks prior to study entry; or stated history of congestive heart failure
- Current use of glucocorticoid steroids with the exception of topical use.
- History of renal insufficiency serum creatinine greater than 1.4 mgdL for women and greater than 1.5 for men
- Subjects with the following laboratory values: hemoglobin less than 10 gdL, WBC less than 3000mL, platelet less than 100,000mL, ALT greater than 3x ULN, total bilirubin greater than 2x ULN
- Stated current severe hepatic disease
- History or evidence of alcoholism or drug abuse
- History or evidence of hyperthyroidism or hypothyroidism
- History of malignancy within the last 5 years
- Consumption of any investigational drug within 30 days prior to enrollment.
- Taking any herbals or dietary supplements during the past 8 weeks that could profoundly affect appetite, weight or glucose metabolism
- Voluntary or involuntary weight loss of greater than 7 percents body weight in past 8 week
- History of major eating disorders, such as anorexia nervosa or bulimia nervosa
- Allergy to Glucerna SR or its content
- History of mental incapacity or language barriers that may preclude adequate understanding or cooperation in the study
- Current or concomitant illness that would interfere with the subject's ability to perform the study or that would confound the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, and Parallel Study to Evaluate the Postprandial Metabolic Response After 24-Week Use of Glucerna SR in Obese Asian Subjects With Type 2 Diabetes
This is a phase 4, 24-week, randomized, parallel, open-label study of a meal replacement program with Glucerna SR in obese Asian participants with type 2 diabetes. The duration of each subject's participation will be approximately 28 weeks, including a lead-in period of 2 weeks and a 2-week post-treatment telephone follow-up. A sufficient number of Asian subjects with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion criteria and none of the exclusion criteria will be entered into the study to randomize approximately 60 subjects. Approximately 60 participants will be randomized to receive either (1) a meal replacement program with Glucerna SR on top of the Exchange-diet plan (EDP) or (2) an caloric-matched EDP only. The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes
Read the detailed description
A sufficient number of Asian subjects (expected to be approximately 90) with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion criteria and none of the exclusion criteria will be entered into the study to randomize approximately 60 subjects. The eligible obese subjects with type 2 diabetes will be entered into a 2-week lead-in period with EDP after individual diet/lifestyle consultation to implement nutrition therapy into their existing diabetes management. The diet recommendations of the EDP at the lead-in period will be based on the nutrition recommendations from the ADA including carbohydrate and monounsaturated fat together provided 60-70 % of energy intake, reduced intakes of saturated fat (< 10 % of total calories) and cholesterol (< 300 mg/day) and protein intake around 15-20 % of total daily energy.
Approximately 60 participants will be randomized at Week 0 (Visit 3) in a 1:1 ratio to receive either (1) a meal replacement program with Glucerna SR on top of the EDP or (2) an caloric-matched EDP only. The participants will receive an educational program of diet, exercise, and behavioral strategies at randomization. Each randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with EDP only will receive a meal plan like they have in the lead-in period. All study subjects will be placed on a diet plan with 500 ~ 800 kcal/day less than their estimated daily maintenance energy requirement and receive an individualized exercise prescription to facilitate an optimal diabetes management. The participants will visit the clinics at 4-week intervals for 24 weeks after randomization to evaluate the efficacy and the safety parameters. The participants will receive two different meal tests at both the baseline and the end of the study. The macronutrient composition in the meal test protocol 1 is a 480 Kcal Glucerna SR breakfast with 50 % CHO, 20 % protein, and 30 % fat. The test meal protocol 2 is a 480 Kcal sandwich breakfast with 63 % CHO, 20 % protein, and 17 % fat. The primary efficacy variable will be the change from baseline in incremental area under curve (∆AUC) of glucose response after a Glucerna-SR test meal between the two groups.
A telephone follow-up will be performed 2 weeks after the study to evaluate any condition related to the study.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Glucerna SR
- Keywords
- type 2 diabetes, meal replacement, postprandial response, Glucerna SR
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucerna SRDietary supplement
Also called exchange-diet plan
Each randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with exchange-diet plan only will receive a meal plan like they have in the lead-in period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | a meal replacement program with Glucerna SR on top of the exchange-diet plan Receives: Dietary Supplement: Glucerna SR |
| 2 | Active comparator | an caloric-matched exchange-diet plan only. Receives: Dietary Supplement: Glucerna SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes
Measured: 24 weeks
Secondary outcomes (1)
evaluate the efficacy and safety of a meal replacement program with Glucerna SR vs. an EDP based on the nutrition therapy recommendations from the ADA on anthropometric measurements, lipid profile, meal-related metabolic changes and quality of life
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Abbott
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Low-Tone Ho, MD, Study chair, Taipei Veterans eneral HospitalChii-Min Hwu, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631774
- Sponsor's protocol ID
- GSR Version 2
- Status last verified
- Dec 2011
- First submitted
- 2 Mar 2008
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, and Parallel Study to Evaluate the Postprandial Metabolic Response After 24-Week Use of Glucerna SR in Obese Asian Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00631774
- Acronym / sponsor ID
- GSR Version 2
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- type 2 diabetes, meal replacement, postprandial response, Glucerna SR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Abbott
- Study start
- Nov 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Mar 2008 (estimated)
- 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 is a phase 4, 24-week, randomized, parallel, open-label study of a meal replacement program with Glucerna SR in obese Asian participants with type 2 diabetes. The duration of each subject's participation will be approximately 28 weeks, including a lead-in period of 2 weeks and a 2-week post-treatment telephone follow-up. A sufficient number of Asian subjects with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion criteria and none of the exclusion criteria will be entered into the study to randomize approximately 60 subjects. Approximately 60 participants will be randomized to receive either (1) a meal replacement program with Glucerna SR on top of the Exchange-diet plan (EDP) or (2) an caloric-matched EDP only. The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes
Detailed description
A sufficient number of Asian subjects (expected to be approximately 90) with type 2 diabetes who have a BMI 18 between 25-40 kg/m2 and meet all the inclusion criteria and none of the exclusion criteria will be entered into the study to randomize approximately 60 subjects. The eligible obese subjects with type 2 diabetes will be entered into a 2-week lead-in period with EDP after individual diet/lifestyle consultation to implement nutrition therapy into their existing diabetes management. The diet recommendations of the EDP at the lead-in period will be based on the nutrition recommendations from the ADA including carbohydrate and monounsaturated fat together provided 60-70 % of energy intake, reduced intakes of saturated fat (< 10 % of total calories) and cholesterol (< 300 mg/day) and protein intake around 15-20 % of total daily energy.
Approximately 60 participants will be randomized at Week 0 (Visit 3) in a 1:1 ratio to receive either (1) a meal replacement program with Glucerna SR on top of the EDP or (2) an caloric-matched EDP only. The participants will receive an educational program of diet, exercise, and behavioral strategies at randomization. Each randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with EDP only will receive a meal plan like they have in the lead-in period. All study subjects will be placed on a diet plan with 500 ~ 800 kcal/day less than their estimated daily maintenance energy requirement and receive an individualized exercise prescription to facilitate an optimal diabetes management. The participants will visit the clinics at 4-week intervals for 24 weeks after randomization to evaluate the efficacy and the safety parameters. The participants will receive two different meal tests at both the baseline and the end of the study. The macronutrient composition in the meal test protocol 1 is a 480 Kcal Glucerna SR breakfast with 50 % CHO, 20 % protein, and 30 % fat. The test meal protocol 2 is a 480 Kcal sandwich breakfast with 63 % CHO, 20 % protein, and 17 % fat. The primary efficacy variable will be the change from baseline in incremental area under curve (∆AUC) of glucose response after a Glucerna-SR test meal between the two groups.
A telephone follow-up will be performed 2 weeks after the study to evaluate any condition related to the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Glucerna SRa meal replacement program with Glucerna SR on top of the exchange-diet plan |
| 2 | Active comparator | Dietary Supplement: Glucerna SRan caloric-matched exchange-diet plan only. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Asians
- Diagnosed type 2 diabetes
- BMI between 25 and 40 kgm2
- Aged between 20 and 75 years old
- Current HbA1c between 6.0 and 8.5 percents
Key exclusion criteria (21 listed)
- History or evidence of type 1 diabetes
- Screening fasting glucose greater than 240 mgdL
- Treatment with insulin, alpha-glucosidase inhibitor, incretin mimetics, or DPP-IV inhibitors in the past 8 weeks
- History of severe hypoglycemia in the past 12 weeks
- History of severe diabetes complications e.g. amputation, blindness, diabetic coma
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 SRAlso: exchange-diet planEach randomized subject in the meal replacement group will receive Glucerna SR to replace one meal (breakfast) and one pre-sleep snack for 24 weeks. The subjects in the group with exchange-diet plan only will receive a meal plan like they have in the lead-in period. | Dietary supplement | 1, 2 |
Primary outcome
The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes
Time frame: 24 weeks
1 secondary outcome
evaluate the efficacy and safety of a meal replacement program with Glucerna SR vs. an EDP based on the nutrition therapy recommendations from the ADA on anthropometric measurements, lipid profile, meal-related metabolic changes and quality of life
Time frame: 24 weeks
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 6 Dec 2011.
Related trials for Type 2 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
Low-Tone Ho, MD study chair
Taipei Veterans eneral Hospital
Chii-Min Hwu, MD principal investigator
Taipei Veterans General Hospital, Taiwan
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 and Obesity, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 8 inclusion and 21 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 6 Dec 2011. 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 Taiwan. 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?
The primary objective of this study is to evaluate the effect of a diet program including Glucerna SR as a meal replacement on postprandial glucose response after using Glucerna SR for 24 weeks in obese Asian subjects with type 2 diabetes (time frame: 24 weeks). 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 6 Dec 2011; AzTrials last refreshed its copy on 2 Nov 2026.