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Completed

NCT Number: NCT01196728

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 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.

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, State of Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CM3.1-AC100

Drug

SAD study with single ascending subcutaneous doses

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CellMed AG, a subsidiary of BTG plc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 8, 2010
Registry last updated
Dec 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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