A Study of LY2599506 in Patients With Type 2 Diabetes

This study has been terminated.
(Terminated due to nonclinical safety findings)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01024244
First received: December 1, 2009
Last updated: November 29, 2011
Last verified: November 2011
Results First Received: September 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Placebo
Drug: LY2599506

  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
0 Milligrams (mg) Placebo Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
100 mg LY2599506 Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
200 mg LY2599506 Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
400 mg LY2599506 Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
200 mg LY2599506 Once Daily Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).

Participant Flow:   Overall Study
    0 Milligrams (mg) Placebo     100 mg LY2599506     200 mg LY2599506     400 mg LY2599506     200 mg LY2599506 Once Daily  
STARTED     22     12     15     14     15  
COMPLETED     5     1     1     1     1  
NOT COMPLETED     17     11     14     13     14  
Adverse Event                 1                 2                 0                 1                 2  
Entry Criteria Not Met                 0                 1                 0                 0                 0  
Lack of Efficacy                 1                 0                 0                 0                 0  
Protocol Violation                 1                 0                 0                 0                 2  
Sponsor Decision                 14                 7                 14                 12                 10  
Withdrawal by Subject                 0                 1                 0                 0                 0  



  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
0 Milligrams (mg) Placebo Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
100 mg LY2599506 Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
200 mg LY2599506 Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
400 mg LY2599506 Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
200 mg LY2599506 Once Daily Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
Total Total of all reporting groups

Baseline Measures
    0 Milligrams (mg) Placebo     100 mg LY2599506     200 mg LY2599506     400 mg LY2599506     200 mg LY2599506 Once Daily     Total  
Number of Participants  
[units: participants]
  22     12     15     14     15     78  
Age  
[units: years]
Mean ± Standard Deviation
  56.69  ± 7.60     55.94  ± 6.66     56.55  ± 7.53     59.94  ± 10.88     59.25  ± 5.83     57.62  ± 7.81  
Gender  
[units: participants]
           
Female     7     6     6     4     5     28  
Male     15     6     9     10     10     50  
Ethnicity (NIH/OMB)  
[units: participants]
           
Hispanic or Latino     3     3     1     1     0     8  
Not Hispanic or Latino     19     9     14     13     15     70  
Unknown or Not Reported     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
           
Australia     0     1     0     3     4     8  
Puerto Rico     3     2     1     1     0     7  
Russian Federation     4     3     7     4     3     21  
Spain     11     4     6     5     5     31  
United States     4     2     1     1     3     11  
Duration of Diabetes in Years  
[units: years]
Mean ± Standard Deviation
  5.71  ± 4.26     3.55  ± 4.87     5.54  ± 4.43     5.12  ± 3.34     5.78  ± 4.15     5.25  ± 4.18  
Percentage of Glycosylated Fraction of Hemoglobin A1c [1]
[units: percentage¬†of¬†glycosylated¬†hemoglobin]
Mean ± Standard Deviation
  8.10  ± 0.63     7.48  ± 0.71     7.89  ± 0.45     7.88  ± 0.74     7.79  ± 0.83     7.86  ± 0.69  
[1] HbA1c: hemoglobin A1c, glycosylated fraction of hemoglobin A (%)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks   [ Time Frame: Baseline, 12 weeks ]

2.  Secondary:   Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

3.  Secondary:   Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

4.  Secondary:   Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

5.  Secondary:   Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

6.  Secondary:   Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

7.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

8.  Secondary:   Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period   [ Time Frame: Baseline through 16 weeks ]

9.  Secondary:   Change From Baseline in Body Weight at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

10.  Secondary:   Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks   [ Time Frame: Baseline, 4 weeks, 12 weeks, 16 weeks ]

11.  Secondary:   Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period   [ Time Frame: Baseline through 12 weeks ]

12.  Secondary:   Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period   [ Time Frame: Baseline through 12 weeks ]

13.  Secondary:   Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period   [ Time Frame: Baseline through 12 weeks, Baseline through 16 weeks ]

14.  Secondary:   Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

15.  Secondary:   Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

16.  Secondary:   Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]

17.  Secondary:   Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period   [ Time Frame: Baseline through 12 weeks ]

18.  Secondary:   Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506   [ Time Frame: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12 ]

19.  Secondary:   Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506   [ Time Frame: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12 ]

20.  Secondary:   30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall   [ Time Frame: Baseline through 16 weeks ]

21.  Secondary:   Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks   [ Time Frame: Baseline, 12 weeks, 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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
Since Study GMAH was terminated after enrolling only 78 participants with just 10 participants completing 12 weeks of treatment with LY2599506, only disposition, demographics, and safety data are reported.  


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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01024244     History of Changes
Other Study ID Numbers: 12781, I2Q-MC-GMAH
Study First Received: December 1, 2009
Results First Received: September 15, 2011
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation