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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01196728
Other study ID # CellMed CM3.1-AC100/03
Secondary ID 2010-020895-49
Status Completed
Phase Phase 1
First received September 3, 2010
Last updated December 3, 2010
Start date September 2010
Est. completion date November 2010

Study information

Verified date December 2010
Source CellMed AG, a subsidiary of BTG plc.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
CM3.1-AC100
SAD study with single ascending subcutaneous doses

Locations

Country Name City State
Germany Parexel International GmbH Berlin

Sponsors (1)

Lead Sponsor Collaborator
CellMed AG, a subsidiary of BTG plc.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
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 Yes
Secondary PK samples for CM3.1-AC100 Pharmacokinetics:
AUC, AUC0-4h, AUC0-t, Cmax, tmax, t1/2lz, ?z, CL/F, Vz/F of CM3.1-AC100
Intense PK-sampling during the 24 hours following administration of CM3.1-AC100 No
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