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:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00359879
First received: August 1, 2006
Last updated: June 6, 2014
Last verified: June 2014
  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 AstraZeneca:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00359879     History of Changes
Other Study ID Numbers: H8O-CR-GWBH
Study First Received: August 1, 2006
Last Updated: June 6, 2014
Health Authority: Mexico: Ministry of Health
Brazil: Ministry of Health

Keywords provided by AstraZeneca:
diabetes
exenatide
Lilly
Amylin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014