Back to results

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

Primary Purpose

Type II Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

CM3.1-AC100

About this trial

This is an interventional basic science trial for Type II Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of signed and dated informed consent prior to any study specific procedures
Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months
Male or female patient aged 18 to 75 years at screening, both inclusive
BMI >22 to ≤40 kg/m2 at screening

Exclusion Criteria:

Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly
Fasting C-peptide < 500 pM at screening
Acute gastrointestinal symptoms at the time of screening and/or Day -1
Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis

Sites / Locations

Parexel International GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

CM3.1-AC100 dose A

CM3.1-AC100 dose B

CM3.1-AC100 dose C

Placebo

Arm Description

Compound CM3.1-AC100 s.c.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01196728

First Posted

September 3, 2010

Last Updated

December 3, 2010

Sponsor

CellMed AG, a subsidiary of BTG plc.

1. Study Identification

Unique Protocol Identification Number

NCT01196728

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

CellMed AG, a subsidiary of BTG plc.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type II Diabetes Mellitus

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CM3.1-AC100 dose A

Arm Type

Experimental

Arm Description

Compound CM3.1-AC100 s.c.

Arm Title

CM3.1-AC100 dose B

Arm Type

Experimental

Arm Description

Compound CM3.1-AC100 s.c.

Arm Title

CM3.1-AC100 dose C

Arm Type

Experimental

Arm Description

Compound CM3.1-AC100 s.c.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CM3.1-AC100

Intervention Description

SAD study with single ascending subcutaneous doses

Primary Outcome Measure Information:

Title

Safety measurements

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

PK samples for CM3.1-AC100

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent prior to any study specific procedures Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months Male or female patient aged 18 to 75 years at screening, both inclusive BMI >22 to ≤40 kg/m2 at screening Exclusion Criteria: Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly Fasting C-peptide < 500 pM at screening Acute gastrointestinal symptoms at the time of screening and/or Day -1 Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Geigle, Dr. med.

Organizational Affiliation

CellMed AG, a subsidiary of BTG plc.

Official's Role

Study Chair

Facility Information:

Facility Name

Parexel International GmbH

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs