Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT01916265
First received: July 25, 2013
Last updated: February 4, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 1
Drug: Glucagon
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomised, Single Center, Three-period Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages at Four Different Blood Glucose Concentrations

Resource links provided by NLM:


Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • AUCGlucose of different glucagon dosages given s.c. [ Time Frame: 90 min after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: August 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucagon level: 0,11 and 1 mg
Glucagon level: 0,11 and 1 mg
Drug: Glucagon
Experimental: Glucagon level: 0,22 and 0,66 mg
Glucagon level: 0,22 and 0,66 mg
Drug: Glucagon
Experimental: Glucagon level: 0,44 and 0,33 mg
Glucagon level: 0,44 and 0,33 mg
Drug: Glucagon

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916265

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, NRW, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
European Union
  More Information

No publications provided

Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01916265     History of Changes
Other Study ID Numbers: PCDiab01
Study First Received: July 25, 2013
Last Updated: February 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on July 22, 2014