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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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 T2DM.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CellMed AG, a subsidiary of BTG plc.

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent prior to any study specific procedures

2. Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months

3. Male or female patient aged 18 to 75 years at screening, both inclusive

4. BMI >22 to ≤40 kg/m2 at screening

Exclusion Criteria:

1. Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly

2. Fasting C-peptide < 500 pM at screening

3. Acute gastrointestinal symptoms at the time of screening and/or Day -1

4. Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis