Effects of Human Unacylated Ghrelin on Insulin Sensitivity during Euglycemic-Hyperinsulinemic- Clamp in Patients with Type 2 Diabetes Mellitus
- Conditions
- Obesity and mild diabetes10018424
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
• Female or Male subject of 18 years of age or older;
• Documented diagnosis of type 2 diabetes as defined by American Diabetes Association;
• Diagnosis of type 2 diabetes for at least 3 months prior to screening;
• Metformin monotherapy for at least 3 months prior to screening is allowed
• Screening HbA1c between 6.5% and 8.5%;
• Body Mass Index between 25 and 35 kg/m2;
• History of or presence of active concomitant conditions or disease that would interfere with the protocol conduct and study assessments, as judged by the investigator;
• History or presence of long-term type 2 diabetes complications;
• Clinically significant abnormalities in laboratory evaluation at screening, as judged by the investigator;
• Use of systemic corticosteroids within 60 days prior to screening;
• If female, pregnancy or breast feeding;
• Drug or alcohol dependence or abuse;
• Participation in a trial of an experimental drug or device within 60 days prior to screening; 30 days for subjects that pariticpated in the oGTT study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Insulin levels</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>