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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

373 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

NCT01697618

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE2

Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes

NCT00097279

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE3

Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

NCT00097877

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE3

Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

NCT00807092

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE4

Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

NCT00619697

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

biphasic insulin aspart

Intervention Type DRUG

exenatide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No