Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359879
• Other study ID #: H8O-CR-GWBH
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2006
• Last updated: February 20, 2015
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of HealthBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner)
• exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner)

Locations

Country	Name	City	State
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
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Merida	Yucatan
Mexico	Research Site	Mexico City
Mexico	Research Site	Monterrey	Nuevo Leon
Mexico	Research Site	San Luis Potosi

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

Brazil,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, Week 12	No
Secondary	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)	Baseline, Weeks 4, 8, 12	No
Secondary	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)	Baseline, Weeks 4, 8, 12	No
Secondary	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)	Baseline, Weeks 4, 8, 12	No