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

December 3, 2010 updated by: CellMed AG, a subsidiary of BTG plc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • Parexel International GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intense PK-sampling during the 24 hours following administration of CM3.1-AC100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellMed AG, a subsidiary of BTG plc.

Investigators

  • Study Chair: Peter Geigle, Dr. med., CellMed AG, a subsidiary of BTG plc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2010

Last Update Submitted That Met QC Criteria

December 3, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CellMed CM3.1-AC100/03
  • 2010-020895-49 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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