ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01916265
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : February 5, 2014
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Drug: Glucagon Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. AUCGlucose of different glucagon dosages given s.c. [ Time Frame: 90 min after dosing ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916265


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

Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01916265     History of Changes
Other Study ID Numbers: PCDiab01
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: August 2013

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
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins