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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01196728
Enrollment
16
Registered
2010-09-08
Start date
2010-09-30
Completion date
2010-11-30
Last updated
2010-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes Mellitus

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.

Interventions

DRUGCM3.1-AC100

SAD study with single ascending subcutaneous doses

Sponsors

CellMed AG, a subsidiary of BTG plc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safety measurementsSafety will be monitored continously and safety assessments will be made on several occasions throughout the whole studyAEs, 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

MeasureTime frameDescription
PK samples for CM3.1-AC100Intense PK-sampling during the 24 hours following administration of CM3.1-AC100Pharmacokinetics: AUC, AUC0-4h, AUC0-t, Cmax, tmax, t1/2lz, λz, CL/F, Vz/F of CM3.1-AC100

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026