Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00313001
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). The study will compare A1C reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to patients receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-08
• Study First Submitted QC: 2006-04-08
• Study First Posted: 2006-04-11
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

• Type 2 diabetes
• HbA1C: At least 8%
• Patients that were never treated with insulin before
• Current therapy with metformin and a sulfonylurea.

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Exclusion Criteria

• History of recurrent, severe hypoglycemia
• Hepatic insufficiency: ALT, AST or alkaline phosphatase > 2.5 times upper limits of laboratory's normal
• Renal insufficiency: serum creatinine > 1.3 mg/dL (males) or > 1.2 mg/dL (females)
• Severe gastrointestinal disease, including gastroparesis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Superiority as assessed by HbA1c reduction	at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Safety variables
Patient satisfaction

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Plainsboro, New Jersey, United States