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

Type II Diabetes Mellitus Clinical Trial

Official 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

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

• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

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