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
2 other identifiers
interventional
16
1 country
1
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 T2DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedDecember 6, 2010
December 1, 2010
2 months
September 3, 2010
December 3, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Safety measurements
AEs, ECGs, BP, pulse, body temperature, laboratory variables, local tolerability including a VAS score for local pain, Present Nausea Intensity (PNI) by a nausea questionnaire and a VAS score of the Overall Nausea Index (ONI)
Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Secondary Outcomes (1)
PK samples for CM3.1-AC100
Intense PK-sampling during the 24 hours following administration of CM3.1-AC100
Study Arms (4)
CM3.1-AC100 dose A
EXPERIMENTALCompound CM3.1-AC100 s.c.
CM3.1-AC100 dose B
EXPERIMENTALCompound CM3.1-AC100 s.c.
CM3.1-AC100 dose C
EXPERIMENTALCompound CM3.1-AC100 s.c.
Placebo
PLACEBO COMPARATORPlacebo for compound CM3.1-AC100 s.c.
Interventions
SAD study with single ascending subcutaneous doses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parexel International GmbH
Berlin, State of Berlin, 14050, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter Geigle, Dr. med.
CellMed AG, a subsidiary of BTG plc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 3, 2010
First Posted
September 8, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
December 6, 2010
Record last verified: 2010-12