Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

Diabetes Mellitus Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916265
• Other study ID #: PCDiab01
• Status: Completed
• Phase: Phase 1
• First received: July 25, 2013
• Last updated: February 4, 2014
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: August 2013
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Glucagon

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH	European Union

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCGlucose of different glucagon dosages given s.c.		90 min after dosing	No