Status:
COMPLETED
Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes
Lead Sponsor:
CellMed AG, a subsidiary of BTG plc.
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to assess the safety and tolerability of the Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc) doses in patients with T...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent prior to any study specific procedures
- Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months
- Male or female patient aged 18 to 75 years at screening, both inclusive
- BMI \>22 to ≤40 kg/m2 at screening
Exclusion
- Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly
- Fasting C-peptide \< 500 pM at screening
- Acute gastrointestinal symptoms at the time of screening and/or Day -1
- Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01196728
Start Date
September 1 2010
End Date
November 1 2010
Last Update
December 6 2010
Active Locations (1)
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1
Parexel International GmbH
Berlin, State of Berlin, Germany, 14050