Status:
COMPLETED
A Study to Evaluate the Postprandial Metabolic Response After Use of Glucerna SR in Obese Type 2 Diabetes
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
Abbott
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief 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 parti...
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 criteri...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00631774
Start Date
November 1 2007
End Date
January 1 2009
Last Update
December 6 2011
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan