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CompletedNCT01196728Updated Dec 6, 2010

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

A Phase 1 interventional study of CM3.1-AC100 in Type II Diabetes Mellitus, sponsored by CellMed AG, a subsidiary of BTG plc.. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-12-06.

Sponsored by CellMed AG, a subsidiary of BTG plc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type II Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 16 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

CellMed AG, a subsidiary of BTG plc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    CM3.1-AC100 dose A

    Compound CM3.1-AC100 s.c.

    Drug: CM3.1-AC100

  • Experimental
    CM3.1-AC100 dose B

    Compound CM3.1-AC100 s.c.

    Drug: CM3.1-AC100

  • Experimental
    CM3.1-AC100 dose C

    Compound CM3.1-AC100 s.c.

    Drug: CM3.1-AC100

  • Placebo comparator
    Placebo

    Placebo for compound CM3.1-AC100 s.c.

    Drug: CM3.1-AC100

Interventions

  • DrugCM3.1-AC100

    SAD study with single ascending subcutaneous doses

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Secondary outcomes

  1. 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

    Time frame: Intense PK-sampling during the 24 hours following administration of CM3.1-AC100

07

Study locations

1 site
  • Parexel International GmbH
    Berlin, 14050, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01196728
Lead sponsor
CellMed AG, a subsidiary of BTG plc.
First posted
Sep 8, 2010
Start date
Sep 2010
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Dec 6, 2010

Study contacts

Peter Geigle, Dr. med.
study chair · CellMed AG, a subsidiary of BTG plc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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