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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Arm that first receives exenatide, then crosses over to insulin glargine

Arm that first receives insulin glargine, then crosses over to exenatide

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels

Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks

Link to study results on ClinicalStudyResults.org

Research Site

Efficacy of Exenatide Compared with Insulin Glargine in Patients with Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy

Change in HbA1c from Baseline to the end of each 16-week period.  There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.

Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires [Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument] from Baseline to the end of each 16-week exenatide or insulin glargine period

Arms	Assigned Interventions
Experimental: exenatide/insulin glargine Arm that first receives exenatide, then crosses over to insulin glargine	Drug: exenatide/insulin glargine Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels Other Name: Byetta Other Name: AC2003 Other Name: syntheitc exenden-4
Experimental: Insulin glargine/exenatide Arm that first receives insulin glargine, then crosses over to exenatide	Drug: insulin glargine/exenatide Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks Other Name: Byetta Other Name: AC2993 Other Name: synthetic exenden-4

Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

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Link to study results on ClinicalStudyResults.org

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