We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01196728
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : December 6, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: CM3.1-AC100 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2010
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Safety measurements [ Time Frame: 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 :
  1. PK samples for CM3.1-AC100 [ Time Frame: 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



Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number )
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2010

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