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

August 1, 2006
June 6, 2014
September 2006
July 2007   (final data collection date for primary outcome measure)
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
To test the hypothesis that glycemic control achieved with exenatide administered subcutaneously before lunch and dinner is noninferior to that obtained with the administration before breakfast and dinner in patients with type 2 diabetes.
Complete list of historical versions of study NCT00359879 on ClinicalTrials.gov Archive Site
  • 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)
To compare exenatide administered either before breakfast and dinner or before lunch and dinner with respect to various pharmacodynamic measurements, body weight, and safety and tolerability.
Not Provided
Not Provided
 
Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: exenatide
    subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
    Other Name: Byetta
  • Drug: exenatide
    subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)
    Other Name: Byetta
  • Experimental: 1 - exenatide before breakfast and dinner
    Intervention: Drug: exenatide
  • Active Comparator: 2 - exenatide before lunch and dinner
    Intervention: Drug: exenatide
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. Epub 2008 Jul 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
377
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Mexico
 
NCT00359879
H8O-CR-GWBH
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP