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

This study has been completed.
Sponsor:
Information provided by:
CellMed AG, a subsidiary of BTG plc.
ClinicalTrials.gov Identifier:
NCT01196728
First received: September 3, 2010
Last updated: December 3, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Type II Diabetes Mellitus
Drug: CM3.1-AC100
Phase 1

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

Resource links provided by NLM:


Further study details as provided by CellMed AG, a subsidiary of BTG plc.:

Primary Outcome Measures:
  • Safety measurements [ Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study ] [ Designated as safety issue: Yes ]
    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:
  • PK samples for CM3.1-AC100 [ Time Frame: Intense PK-sampling during the 24 hours following administration of CM3.1-AC100 ] [ Designated as safety issue: No ]

    Pharmacokinetics:

    AUC, AUC0-4h, AUC0-t, Cmax, tmax, t1/2lz, λz, CL/F, Vz/F of CM3.1-AC100



Estimated Enrollment: 16
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CM3.1-AC100 dose A
Compound CM3.1-AC100 s.c.
Drug: CM3.1-AC100
SAD study with single ascending subcutaneous doses
Experimental: CM3.1-AC100 dose B
Compound CM3.1-AC100 s.c.
Drug: CM3.1-AC100
SAD study with single ascending subcutaneous doses
Experimental: CM3.1-AC100 dose C
Compound CM3.1-AC100 s.c.
Drug: CM3.1-AC100
SAD study with single ascending subcutaneous doses
Placebo Comparator: Placebo
Placebo for compound CM3.1-AC100 s.c.
Drug: CM3.1-AC100
SAD study with single ascending subcutaneous doses

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196728

Locations
Germany
Parexel International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
CellMed AG, a subsidiary of BTG plc.
Investigators
Study Chair: Peter Geigle, Dr. med. CellMed AG, a subsidiary of BTG plc.
  More Information

No publications provided

Responsible Party: Dr. Peter Geigle, Cellmed AG
ClinicalTrials.gov Identifier: NCT01196728     History of Changes
Other Study ID Numbers: CellMed CM3.1-AC100/03, 2010-020895-49
Study First Received: September 3, 2010
Last Updated: December 3, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014