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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: exenatide

• Registration Number: NCT00359879
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-03
• Study Start: 2006-09
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 - exenatide before breakfast and dinner	exenatide	-
2 - exenatide before lunch and dinner	exenatide	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12	Baseline, Week 12	Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12	Baseline, Weeks 4, 8, 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)
Change in body weight from Baseline to Week 12, and if measured, at each visit	Baseline, Weeks 4, 8, 12	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	Baseline, Weeks 4, 8, 12	Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)

Trial Locations

Locations (1)

Research Site; 🇲🇽 San Luis Potosi, Mexico