Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

• Sponsor: Profil Institut für Stoffwechselforschung GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01916265
• Collaborator: European Union (Other)
• Enrollment: 6
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. AUCGlucose of different glucagon dosages given s.c. [90 min after dosing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Profil Institut für Stoffwechselforschung GmbH	Neuss	NRW	Germany	41460

Sponsors and Collaborators

• Profil Institut für Stoffwechselforschung GmbH
• European Union

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Profil Institut für Stoffwechselforschung GmbH
• ClinicalTrials.gov Identifier: NCT01916265
• Other Study ID Numbers: PCDiab01
• First Posted: Aug 5, 2013
• Last Update Posted: Feb 5, 2014
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Diabetes Mellitus, Type 1; Glucagon

Study Results

No Results Posted as of Feb 5, 2014