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

Phase 1

Completed

• Conditions: Type II Diabetes Mellitus
• Interventions: Drug: CM3.1-AC100

• Registration Number: NCT01196728
• Lead Sponsor: CellMed AG, a subsidiary of BTG plc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-03
• Last Update Posted: 2010-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CM3.1-AC100 dose A	CM3.1-AC100	Compound CM3.1-AC100 s.c.
CM3.1-AC100 dose B	CM3.1-AC100	Compound CM3.1-AC100 s.c.
CM3.1-AC100 dose C	CM3.1-AC100	Compound CM3.1-AC100 s.c.
Placebo	CM3.1-AC100	Placebo for compound CM3.1-AC100 s.c.

Primary Outcome Measures

Name	Time	Method
Safety measurements	Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study	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)

Secondary Outcome Measures

Name	Time	Method
PK samples for CM3.1-AC100	Intense PK-sampling during the 24 hours following administration of CM3.1-AC100	Pharmacokinetics: AUC, AUC0-4h, AUC0-t, Cmax, tmax, t1/2lz, λz, CL/F, Vz/F of CM3.1-AC100

Trial Locations

Locations (1)

Parexel International GmbH; 🇩🇪 Berlin, Germany