| Trial ID: | L6395 |
| Source ID: | NCT01196728
|
| Associated Drug: |
Cm3.1-Ac100
|
| Title: |
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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type II Diabetes Mellitus
|
| Interventions: |
DRUG: CM3.1-AC100
|
| Outcome Measures: |
Primary: 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: PK samples for CM3.1-AC100, Pharmacokinetics: AUC, AUC0-4h, AUC0-t, Cmax, tmax, t1/2lz, λz, CL/F, Vz/F of CM3.1-AC100, Intense PK-sampling during the 24 hours following administration of CM3.1-AC100
|
| Sponsor/Collaborators: |
Sponsor: CellMed AG, a subsidiary of BTG plc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2010-09
|
| Completion Date: |
2010-11
|
| Results First Posted: |
|
| Last Update Posted: |
2010-12-06
|
| Locations: |
Parexel International GmbH, Berlin, 14050, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01196728
|
