Back to resultsComparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
exenatide
exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring diabetes, exenatide, Lilly, Amylin
Eligibility Criteria
Inclusion Criteria: Diagnosed with type 2 diabetes. Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD. HbA1c between 7.1% and 10.0%, inclusive. Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2 Exclusion Criteria: Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening. Have characteristics contraindicating metformin, SU, or TZD use. Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. Have used any prescription drug to promote weight loss within 3 months prior to screening. Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 - exenatide before breakfast and dinner
2 - exenatide before lunch and dinner
Arm Description
Outcomes
Primary Outcome Measures
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12
Secondary Outcome Measures
Change in body weight from Baseline to Week 12, and if measured, at each visit
Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit
Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12
Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Full Information
NCT ID
NCT00359879
First Posted
August 1, 2006
Last Updated
February 20, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00359879
Brief Title
Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
Official Title
Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
diabetes, exenatide, Lilly, Amylin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
377 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 - exenatide before breakfast and dinner
Arm Type
Experimental
Arm Title
2 - exenatide before lunch and dinner
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
Primary Outcome Measure Information:
Title
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Description
Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change in body weight from Baseline to Week 12, and if measured, at each visit
Description
Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Time Frame
Baseline, Weeks 4, 8, 12
Title
Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit
Description
Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)
Time Frame
Baseline, Weeks 4, 8, 12
Title
Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12
Description
Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)
Time Frame
Baseline, Weeks 4, 8, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with type 2 diabetes.
Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
HbA1c between 7.1% and 10.0%, inclusive.
Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2
Exclusion Criteria:
Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
Have characteristics contraindicating metformin, SU, or TZD use.
Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
Have used any prescription drug to promote weight loss within 3 months prior to screening.
Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Malone, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Campinas
Country
Brazil
Facility Name
Research Site
City
Curitiba
Country
Brazil
Facility Name
Research Site
City
Fortaleza
Country
Brazil
Facility Name
Research Site
City
Goiania
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Research Site
City
Salvador
Country
Brazil
Facility Name
Research Site
City
Sao Jose Do Rio Preto
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
Country
Brazil
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Research Site
City
Merida
State/Province
Yucatan
Country
Mexico
Facility Name
Research Site
City
Aguascalientes
Country
Mexico
Facility Name
Research Site
City
Mexico City
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
18662495
Citation
Forti A, Garcia EG, Yu MB, Jimenez MC, Brodows RG, Oliveira JH. Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. Curr Med Res Opin. 2008 Sep;24(9):2437-47. doi: 10.1185/03007990802282398. Epub 2008 Jul 24.
Results Reference
derived
Learn more about this trial
Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
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