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Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Sanofi
Information provided by (Responsible Party):
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT01089569
First received: March 17, 2010
Last updated: April 19, 2017
Last verified: October 2013
Results First Received: October 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Exenatide
Drug: Insulin Glargine

  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
Exenatide 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
Insulin Glargine .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Exenatide + Insulin Glargine

Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results


Participant Flow:   Overall Study
    Exenatide   Insulin Glargine   Exenatide + Insulin Glargine
STARTED   20   20   20 
COMPLETED   16   17   16 
NOT COMPLETED   4   3   4 



  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
Exenatide

5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study

Exenatide: refer to Arm detail

Insulin Glargine

.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Insulin Glargine: refer to Arm detail

Exenatide + Insulin Glargine

Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Total Total of all reporting groups

Baseline Measures
   Exenatide   Insulin Glargine   Exenatide + Insulin Glargine   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   17   16   49 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.6  (7.8)   53.8  (7.4)   56.7  (8.7)   56.3  (8.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      6  37.5%      10  58.8%      7  43.8%      23  46.9% 
Male      10  62.5%      7  41.2%      9  56.3%      26  53.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   16   17   16   49 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HbA1c Change   [ Time Frame: baseline to final visit (32 weeks) ]

2.  Secondary:   Change From Baseline in Incidence of Hypoglycemia (Frequency)   [ Time Frame: baseline to final visit (32 weeks) ]

3.  Secondary:   Change From Baseline in Incidence of Hypoglycemia (Degree)   [ Time Frame: baseline to final visit (32 weeks) ]

4.  Secondary:   Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)   [ Time Frame: baseline to final visit (32 weeks) ]

5.  Secondary:   Change From Baseline in CGM Glucose Variability   [ Time Frame: baseline to final visit (32 weeks) ]

6.  Secondary:   Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)   [ Time Frame: baseline - final visit (32 weeks) ]

7.  Secondary:   Change From Baseline in Weight Changes   [ Time Frame: baseline - final visit (32 weeks) ]


  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. Richard M. Bergenstal
Organization: International Diabetes Center
phone: 952-993-1913
e-mail: richard.bergenstal@parknicollet.com


Publications:

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT01089569     History of Changes
Other Study ID Numbers: 03951-10-C
Study First Received: March 17, 2010
Results First Received: October 28, 2016
Last Updated: April 19, 2017