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Characteristics of Glargine in Type 2 Diabetics

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00574912
First received: December 13, 2007
Last updated: March 17, 2017
Last verified: March 2017
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Placebo
Drug: Insulin Glargine 0.5 u/kg body wt SC
Drug: Insulin Glargine 1.0 u/kg body wt SC
Drug: Insulin Glargine 1.5 u/kg body wt SC
Drug: Insulin Glargine 2.0 u/kg body wt SC

  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
12 individuals will be their own controls completing 5 separate 24 hour protocol studies. If a participant does not complete all protocols, another person will be recruited to complete the protocols until there are 12 completed studies in each arm/group.

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
1 All Interventions

Other: 1--All interventions

All participant will be given all 5 interventions in the same order

Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,


Participant Flow:   Overall Study
    1 All Interventions
STARTED   20 
Completed Placebo   12 [1] 
Completed 0.5   12 
Completed 1.0   12 
Completed 1.5   12 
Completed 2.0   12 
COMPLETED   12 
NOT COMPLETED   8 
Could not place IV lines.                3 
scheduling conflicts                3 
Physician Decision                2 
[1] 12 original participants started the trial.



  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.
One participant may have received more than one intervention.

Reporting Groups
  Description
1--All Interventions

Arm: Other: 1--All interventions

All participant will be given all 5 interventions in the same order

Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,


Baseline Measures
   1--All Interventions 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  50.0% 
Male      10  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

1.  Primary:   Maximum Glucose Infusion Rate   [ Time Frame: 24 hours ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Stephen N. Davis
Organization: University of Maryland, Baltimore
phone: 4103282488
e-mail: sdavis@medicine.umaryland.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steve Davis, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00574912     History of Changes
Other Study ID Numbers: IRB#060887-Lantus Glargine
VUMC 32787
Study First Received: December 13, 2007
Results First Received: December 18, 2014
Last Updated: March 17, 2017