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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020895-49 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM3.1-AC100 dose A | Experimental | Compound CM3.1-AC100 s.c. |
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| CM3.1-AC100 dose B | Experimental | Compound CM3.1-AC100 s.c. |
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| CM3.1-AC100 dose C | Experimental | Compound CM3.1-AC100 s.c. |
|
| Placebo | Placebo Comparator | Placebo for compound CM3.1-AC100 s.c. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM3.1-AC100 | Drug | SAD study with single ascending subcutaneous doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Geigle, Dr. med. | CellMed AG, a subsidiary of BTG plc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | State of Berlin | 14050 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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