Trial to Compare the Relative Pharmacodynamic Properties... | NCT01916265

Studies
Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages

NCT01916265

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Status

Completed

Last Update Posted

Feb 5, 2014Estimated

Enrollment

6Estimated

Phase

Phase 1

Conditions

Diabetes Mellitus Type 1

Interventions

Glucagon

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jul 25, 2013

First Submission Date that Met QC Criteria

Aug 1, 2013

First Posted Date

Aug 5, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2014

Last Update Posted Date

Feb 5, 2014Estimated

Name	Class
European Union	OTHER

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glucagon level: 0,11 and 1 mg	Experimental	Glucagon level: 0,11 and 1 mg	Drug: Glucagon
Glucagon level: 0,22 and 0,66 mg	Experimental	Glucagon level: 0,22 and 0,66 mg	Drug: Glucagon
Glucagon level: 0,44 and 0,33 mg	Experimental	Glucagon level: 0,44 and 0,33 mg	Drug: Glucagon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucagon	Drug		Glucagon level: 0,11 and 1 mg Glucagon level: 0,22 and 0,66 mg Glucagon level: 0,44 and 0,33 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCGlucose of different glucagon dosages given s.c.		90 min after dosing

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Profil Institut für Stoffwechselforschung GmbH		Neuss	North Rhine-Westphalia	41460	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005934	Glucagon

Ancestor Terms

ID	Term
D052336	Proglucagon
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided