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A Study of LY2409021 in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01241448
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: LY2409021
Drug: Placebo

  Participant Flow

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
Placebo Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
2.5 mg LY2409021 2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
10 mg LY2409021 10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
20 mg LY2409021 20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Participant Flow:   Overall Study
    Placebo   2.5 mg LY2409021   10 mg LY2409021   20 mg LY2409021
STARTED   66   65   66   66 
Intent-to-Treat Population (ITT)   63   63   64   64 
ITT With ≥1 Post-Baseline Measure   61   61   64   62 
COMPLETED   29   36   43   43 
NOT COMPLETED   37   29   23   23 
Adverse Event                1                0                2                2 
Lost to Follow-up                2                1                1                1 
Physician Decision                0                2                0                0 
Protocol Violation                10                5                3                6 
Sponsor Decision                17                14                12                6 
Withdrawal by Subject                4                5                3                6 
Excluded due to data integrity issues                3                2                2                2 



  Baseline Characteristics

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.
Baseline data is provided for all randomized participants excluding the 9 participants from a single site where data integrity issues were identified (Intent-to-treat population).

Reporting Groups
  Description
Placebo Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
2.5 mg LY2409021 2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
10 mg LY2409021 10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
20 mg LY2409021 20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
Total Total of all reporting groups

Baseline Measures
   Placebo   2.5 mg LY2409021   10 mg LY2409021   20 mg LY2409021   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   63   64   64   254 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.0  (8.79)   57.3  (8.23)   54.6  (8.05)   55.9  (8.82)   55.7  (8.49) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female   23   24   17   19   83 
Male   40   39   47   45   171 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   29   25   26   28   108 
Slovakia   7   7   6   6   26 
Puerto Rico   3   4   3   5   15 
Spain   6   7   7   7   27 
Romania   10   12   12   10   44 
Germany   7   7   9   6   29 
Italy   1   1   1   2   5 
Race 
[Units: Participants]
Count of Participants
         
Asian   1   3   1   0   5 
Black or African American   4   6   2   6   18 
White   58   54   61   58   231 
Ethnicity 
[Units: Participants]
Count of Participants
         
Hispanic or Latino   16   14   13   13   56 
Not Hispanic or Latino   36   31   35   37   139 
Not Reported   11   18   16   14   59 
Diabetes Duration 
[Units: Years]
Mean (Standard Deviation)
 5.8  (5.29)   6.9  (7.23)   5.5  (4.21)   5.8  (6.13)   6.0  (5.81) 
Body Mass Index (BMI) 
[Units: Kilograms per meter squared (kg/m^2)]
Mean (Standard Deviation)
 32.1  (4.63)   31.9  (4.86)   32.3  (4.91)   32.6  (5.27)   32.2  (4.90) 
Waist Circumference 
[Units: Centimeters (cm)]
Mean (Standard Deviation)
 106.7  (12.41)   107.5  (11.16)   107.2  (12.24)   106.8  (12.28)   107.1  (11.97) 
Hemoglobin A1c (HbA1c) 
[Units: Percentage of Hemoglobin A1c (HbA1c)]
Mean (Standard Deviation)
 8.1  (1.00)   8.1  (0.93)   8.1  (0.87)   8.0  (0.92)   8.0  (0.92) 


  Outcome Measures

1.  Primary:   Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)   [ Time Frame: Baseline, 24 weeks ]

2.  Secondary:   Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)   [ Time Frame: Baseline, 24 weeks ]

3.  Secondary:   Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile   [ Time Frame: Baseline, 24 weeks ]

4.  Secondary:   Change From Baseline to 24 Week Endpoint in Plasma Glucose   [ Time Frame: Baseline, 24 weeks ]

5.  Secondary:   Change From Baseline to 24 Week Endpoint in Fasting Insulin   [ Time Frame: Baseline, 24 weeks ]

6.  Secondary:   Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total   [ Time Frame: Baseline, 24 weeks ]

7.  Secondary:   Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile   [ Time Frame: Baseline, 24 weeks ]

8.  Secondary:   Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total)   [ Time Frame: Baseline, 24 weeks ]

9.  Secondary:   Change From Baseline to 24 Week Endpoint in Free Fatty Acids   [ Time Frame: Baseline, 24 weeks ]

10.  Secondary:   Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline, 24 weeks ]

11.  Secondary:   Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B   [ Time Frame: Baseline, 24 week ]

12.  Secondary:   Change From Baseline to 24 Week Endpoint in Weight   [ Time Frame: Baseline, 24 weeks ]

13.  Secondary:   Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021   [ Time Frame: Baseline up to 26 weeks ]

14.  Secondary:   Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021   [ Time Frame: Baseline up to 26 weeks ]

15.  Secondary:   The Percentage of Participants Experiencing a Hypoglycemic Episode   [ Time Frame: Baseline through 24 weeks ]

16.  Secondary:   The 30-Day Adjusted Rate of Hypoglycemic Episodes   [ Time Frame: Baseline through 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01241448     History of Changes
Other Study ID Numbers: 13031
I1R-MC-GLBG ( Other Identifier: Eli Lilly and Company )
First Submitted: November 12, 2010
First Posted: November 16, 2010
Results First Submitted: March 24, 2018
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018