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

Novo Nordisk A/S373 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

373

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

exenatideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, United States

Outcomes

Primary Outcomes

Superiority as assessed by HbA1c reduction

Time frame: at 24 weeks

Secondary Outcomes

Safety variables

Patient satisfaction

Data from ClinicalTrials.gov

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