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
NCT ID: NCT01196728
Last Updated: 2010-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2010-09-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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CM3.1-AC100 dose A
Compound CM3.1-AC100 s.c.
CM3.1-AC100
SAD study with single ascending subcutaneous doses
CM3.1-AC100 dose B
Compound CM3.1-AC100 s.c.
CM3.1-AC100
SAD study with single ascending subcutaneous doses
CM3.1-AC100 dose C
Compound CM3.1-AC100 s.c.
CM3.1-AC100
SAD study with single ascending subcutaneous doses
Placebo
Placebo for compound CM3.1-AC100 s.c.
CM3.1-AC100
SAD study with single ascending subcutaneous doses
Interventions
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CM3.1-AC100
SAD study with single ascending subcutaneous doses
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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CellMed AG, a subsidiary of BTG plc.
INDUSTRY
Responsible Party
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Cellmed AG
Principal Investigators
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Peter Geigle, Dr. med.
Role: STUDY_CHAIR
CellMed AG, a subsidiary of BTG plc.
Locations
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Parexel International GmbH
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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2010-020895-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CellMed CM3.1-AC100/03
Identifier Type: -
Identifier Source: org_study_id