Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00359879
First received: August 1, 2006
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: exenatide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, Weeks 4, 8, 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, Weeks 4, 8, 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, Weeks 4, 8, 12 ] [ Designated as safety issue: No ]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)
| Enrollment: | 377 |
| Study Start Date: | September 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 - exenatide before breakfast and dinner |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
Other Name: Byetta
|
| Active Comparator: 2 - exenatide before lunch and dinner |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
Other Name: Byetta
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359879
Locations
| Brazil | |
| Research Site | |
| Campinas, Brazil | |
| Research Site | |
| Curitiba, Brazil | |
| Research Site | |
| Fortaleza, Brazil | |
| Research Site | |
| Goiania, Brazil | |
| Research Site | |
| Porto Alegre, Brazil | |
| Research Site | |
| Rio de Janeiro, Brazil | |
| Research Site | |
| Salvador, Brazil | |
| Research Site | |
| Sao Jose Do Rio Preto, Brazil | |
| Research Site | |
| Sao Paulo, Brazil | |
| Mexico | |
| Research Site | |
| Guadalajara, Jalisco, Mexico | |
| Research Site | |
| Monterrey, Nuevo Leon, Mexico | |
| Research Site | |
| Merida, Yucatan, Mexico | |
| Research Site | |
| Aguascalientes, Mexico | |
| Research Site | |
| Mexico City, Mexico | |
| Research Site | |
| San Luis Potosi, Mexico | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | James Malone, MD | Eli Lilly and Company |
More Information
No publications provided by Amylin Pharmaceuticals, LLC.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT00359879 History of Changes |
| Other Study ID Numbers: | H8O-CR-GWBH |
| Study First Received: | August 1, 2006 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Mexico: Ministry of Health Brazil: Ministry of Health |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
diabetes exenatide Lilly Amylin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013