Physiologic Response to Glucagon at Varying Insulin Levels

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Oregon Health and Science University
Information provided by (Responsible Party):
W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier:
NCT01483651
First received: November 29, 2011
Last updated: May 19, 2015
Last verified: May 2015
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Basic Science
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: Glucagon
Drug: Insulin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Low, Medium and High Insulin Infusion Rate

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at lowest level with glucagon administration.

Second study is regular insulin infused at medium level with glucagon adminstration.

Third study is regular insulin infused at highest level with glucagon administration.

Low, High and Medium Insulin Infusion Rate

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at lowest level with glucagon administration.

Second study is regular insulin infused at highest level with glucagon adminstration.

Third study is regular insulin infused at medium level with glucagon administration.

Medium, Low and High Insulin Infusion Rate

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at medium level with glucagon administration.

Second study is regular insulin infused at lowest level with glucagon adminstration.

Third study is regular insulin infused at highest level with glucagon administration.

Medium, High and Low Insulin Infusion

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at medium level with glucagon administration.

Second study is regular insulin infused at highest level with glucagon adminstration.

Third study is regular insulin infused at lowest level with glucagon administration.

High, Low and Medium Insulin Infusion

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at highest level with glucagon administration.

Second study is regular insulin infused at lowest level with glucagon adminstration.

Third study is regular insulin infused at medium level with glucagon administration.

High, Medium and Low Insulin Infusion

All study subjects in this arm were randomized as follows:

First study is regular insulin infused at highest level with glucagon administration.

Second study is regular insulin infused at medium level with glucagon adminstration.

Third study is regular insulin infused at lowest level with glucagon administration.


Participant Flow:   Overall Study
    Low, Medium and High Insulin Infusion Rate     Low, High and Medium Insulin Infusion Rate     Medium, Low and High Insulin Infusion Rate     Medium, High and Low Insulin Infusion     High, Low and Medium Insulin Infusion     High, Medium and Low Insulin Infusion  
STARTED     1     3     2     1     2     2  
COMPLETED     1     2     1     1     2     1  
NOT COMPLETED     0     1     1     0     0     1  
Withdrawal by Subject                 0                 1                 1                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants Regular insulin given at each of three study visits with a different infusion rate at each visit, either low, medium or high insulin infusion with glucagon administration.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     0  
Gender  
[units: participants]
 
Female     5  
Male     6  



  Outcome Measures

1.  Primary:   Area Under the Curve for Glucose Above Baseline   [ Time Frame: 60 minutes after each glucagon administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kenneth Ward
Organization: Legacy Health System
phone: 971-570-2632
e-mail: kenward503@msn.com


No publications provided


Responsible Party: W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier: NCT01483651     History of Changes
Other Study ID Numbers: kw02
Study First Received: November 29, 2011
Results First Received: September 8, 2014
Last Updated: May 19, 2015
Health Authority: United States: Institutional Review Board