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Exenatide-study.

Completed
Conditions
Type 2 Diabetes Mellitus.
Registration Number
NL-OMON26218
Lead Sponsor
Eli Lilly and Company, Lilly Nederland BV
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
75
Inclusion Criteria

1. Patients with type 2 diabetes mellitus (m/f);

2. 30-70 years of age;

Exclusion Criteria

1. Use of oral anti-diabetic therapy other than metformine.

2. Clinical significant history or presence of hepatic-, renal-, central nervous system-, gastrointestinal-, haematological- and pulmonary disease;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Glycaemic control and beta-cell function, measured at baseline and after 52 weeks of exenatide or insulin glargine administration.
Secondary Outcome Measures
NameTimeMethod
1. Postprandial blood glucose, lipids, lipoproteins and markers of inflammation, coagulation, endothelial function; <br /><br>2. Proportion of subjects with baseline HbA1c >7.0% that achieve HbA1c £7.0%. Proportion of subjects with baseline HbA1c >6.5% that achieve HbA1c £6.5%; <br /><br>3. Seven-point self-monitored blood glucose profiles.
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