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Adding Liraglutide to High Dose Insulin: Breaking the Cycle

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01505673
First Posted: January 6, 2012
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center
Results First Submitted: August 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes Mellitus
Obesity
Interventions: Drug: Liraglutide
Drug: Saline

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Liraglutide Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline Injection Saline: Placebo injection of 1.8mg saline once daily for 6-months

Participant Flow:   Overall Study
    Liraglutide   Saline Injection
STARTED   35   36 
COMPLETED   32   34 
NOT COMPLETED   3   2 



  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
Liraglutide Liraglutide: Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
Saline Injection Saline: Placebo injection of 1.8mg saline once daily for 6-months
Total Total of all reporting groups

Baseline Measures
   Liraglutide   Saline Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   36   71 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      35 100.0%      36 100.0%      71 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.8  (8.1)   55.5  (6.6)   54.2  (7.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  65.7%      22  61.1%      45  63.4% 
Male      12  34.3%      14  38.9%      26  36.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   32   34   66 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glycemic Control Measured by HbA1c   [ Time Frame: 6-months ]

2.  Secondary:   Pancreatic and Hepatic Triglyceride Content   [ Time Frame: 6-months ]

3.  Secondary:   Weight   [ Time Frame: 6-months ]

4.  Secondary:   Beta-Cell Function   [ Time Frame: 6-months ]

5.  Secondary:   Glucagon   [ Time Frame: 6-months ]

6.  Secondary:   Total Daily Insulin Dose   [ Time Frame: 6-months ]

7.  Secondary:   Number of Daily Injections   [ Time Frame: 6-months ]

8.  Secondary:   Blood Pressure   [ Time Frame: 6-months ]

9.  Secondary:   Lipid Profile   [ Time Frame: 6-months ]

10.  Secondary:   Liver Function Blood Test   [ Time Frame: 6-months ]

11.  Secondary:   Hypoglycemic Events   [ Time Frame: 6-months ]

12.  Secondary:   Quality of Life Survey (QoL) - General Health Perception   [ Time Frame: 6-months ]

13.  Secondary:   Beta-Cell Function   [ Time Frame: 6 months ]

14.  Secondary:   Matsuda Index as a Measure of Beta Cell Function   [ Time Frame: 6 months ]

15.  Secondary:   Beta-cell Function   [ Time Frame: 6 Months ]

16.  Secondary:   Ratio (AUC C-peptide/AUC Glucose)   [ Time Frame: 6 months ]

17.  Secondary:   AUC Glucose   [ Time Frame: 6 months ]

18.  Secondary:   Quality of Life Survey (QoL) - Current Health Perception   [ Time Frame: 6 months ]

19.  Secondary:   Quality of Life Survey (QoL) - Treatment Satisfaction   [ Time Frame: 6 months ]

20.  Secondary:   Quality of Life Survey (QoL) - Treatment Impact   [ Time Frame: 6 months ]

21.  Secondary:   Quality of Life Survey (QoL) - Social or Vocational Worry   [ Time Frame: 6 months ]

22.  Secondary:   Quality of Life Survey (QoL) - Hypoglycemia Fear   [ Time Frame: 6 months ]

23.  Secondary:   Quality of Life Survey (QoL) - Glycemia Control Perception   [ Time Frame: 6 months ]

24.  Secondary:   Quality of Life Survey (QoL) - Lifestyle Flexibility   [ Time Frame: 6 months ]

25.  Secondary:   Quality of Life Survey (QoL) - Social Stigma   [ Time Frame: 6 months ]

26.  Secondary:   Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment   [ Time Frame: 6 months ]

27.  Secondary:   Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment   [ Time Frame: 6 months ]


  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. Ildiko Lingvay
Organization: University of Texas Southwestern Medical Center at Dallas
phone: 214-648-2779
e-mail: ildiko.lingvay@utsouthwestern.edu


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

Responsible Party: Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01505673     History of Changes
Other Study ID Numbers: IIS-000235
First Submitted: January 4, 2012
First Posted: January 6, 2012
Results First Submitted: August 1, 2017
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017