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Completed

NCT Number: NCT01916265

Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

The ultimate goal of the PCDIAB project is to develop a bi-hormonal pump (insulin and glucagon) substituting for the pancreas and facilitating tight euglycemic control in patients with T1DM.

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Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

About this study

The study is planned as open, randomised 3-period cross-over in patients with T1DM. The study will include a total of 6 completing patients. The study is not blinded due to the exploratory nature.

At each of the 3 periods, different blood glucose level will be established in 4 steps (8, 6, 4, and 2.8 mmol/L), and a prefixed glucagon dose will be given per glucose level. The sequence of glucagon dose strength for the three dosing days will be randomized.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects with diabetes mellitus type 1 , as defined by the American Diabetes Association1.
  • Age ≥ 18 and ≤ 65 years.

Exclusion criteria

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Receipt of any investigational medicinal product within 3 months or 5 half-lives of that IMP before randomisation in this trial.

Treatment and study plan

glucagon

Drug

Primary outcomes

  1. AUCGlucose of different glucagon dosages given s.c.

    Time frame: 90 min after dosing

Sponsors and collaborators

Lead sponsor

Profil Institut für Stoffwechselforschung GmbH

Industry

Collaborators

  • European Union

Registry information

Official study title

A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2013
Registry last updated
Feb 5, 2014

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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