A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus (EGO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00630825
First received: February 28, 2008
Last updated: December 8, 2014
Last verified: December 2014
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus Type 2
Interventions: Drug: LY2189265
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
1.0/2.0 Milligram (mg) LY2189265 LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1.0/1.0 Milligram (mg) LY2189265 LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
0.5/1.0 Milligram (mg) LY2189265 LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
Placebo Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks

Participant Flow:   Overall Study
    1.0/2.0 Milligram (mg) LY2189265     1.0/1.0 Milligram (mg) LY2189265     0.5/1.0 Milligram (mg) LY2189265     Placebo  
STARTED     65     65     66     66  
Received at Least One Dose of Study Drug     65     65     66     66  
COMPLETED     56     58     58     60  
NOT COMPLETED     9     7     8     6  
Adverse Event                 4                 4                 3                 1  
Entry Criteria Not Met                 1                 0                 2                 1  
Lost to Follow-up                 1                 1                 1                 1  
Physician Decision                 1                 0                 0                 0  
Withdrawal by Subject                 2                 2                 2                 3  



  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.
Participants who received at least one dose of LY2189265 or Placebo.

Reporting Groups
  Description
1.0/2.0 Milligram (mg) LY2189265 LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1.0/1.0 Milligram (mg) LY2189265 LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
0.5/1.0 Milligram (mg) LY2189265 LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
Placebo Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
Total Total of all reporting groups

Baseline Measures
    1.0/2.0 Milligram (mg) LY2189265     1.0/1.0 Milligram (mg) LY2189265     0.5/1.0 Milligram (mg) LY2189265     Placebo     Total  
Number of Participants  
[units: participants]
  65     65     66     66     262  
Age  
[units: years]
Mean (Standard Deviation)
  54.49  (11.28)     57.46  (11.72)     58.65  (11.69)     55.96  (12.49)     56.65  (11.84)  
Gender  
[units: participants]
         
Female     31     30     31     37     129  
Male     34     35     35     29     133  
Race/Ethnicity, Customized  
[units: participants]
         
African     4     6     5     4     19  
Caucasian     36     39     40     36     151  
East Asian     1     0     0     0     1  
Hispanic     23     20     19     26     88  
Native American     1     0     2     0     3  
Region of Enrollment  
[units: participants]
         
United States     56     56     57     58     227  
Puerto Rico     9     9     9     8     35  
Glycosylated Hemoglobin (HbA1c)  
[units: percentage of glycosylated hemoglobin]
Mean (Standard Deviation)
  8.43  (0.99)     8.25  (0.99)     8.25  (0.89)     8.05  (0.82)     8.24  (0.93)  
Body Mass Index (BMI) [1]
[units: kilograms per square meters (kg/m^2)]
Mean (Standard Deviation)
  34.24  (4.11)     33.85  (3.95)     33.70  (4.11)     33.89  (4.31)     33.92  (4.10)  
Body Weight  
[units: kilograms (kg)]
Mean (Standard Deviation)
  98.60  (18.41)     96.68  (16.51)     94.76  (16.53)     94.74  (15.21)     96.18  (16.68)  
Duration of Diabetes  
[units: years]
Mean (Standard Deviation)
  8.63  (6.92)     8.13  (5.43)     8.97  (7.62)     7.48  (5.41)     8.30  (6.41)  
[1] Body mass index is an estimate of body fat based on body weight divided by height squared.



  Outcome Measures
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1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus   [ Time Frame: Baseline, 16 weeks ]

2.  Secondary:   Change From Baseline in Fasting Blood Glucose   [ Time Frame: Baseline, 16 weeks ]

3.  Secondary:   Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)   [ Time Frame: Baseline and 16 weeks ]

4.  Secondary:   Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles   [ Time Frame: 2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits. ]

5.  Secondary:   Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)   [ Time Frame: Baseline, 16 weeks ]

6.  Secondary:   Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%   [ Time Frame: Baseline and 4 and 8 and 16 weeks ]

7.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, 4, 8, and 16 weeks ]

8.  Secondary:   Change From Baseline in Waist Circumference   [ Time Frame: Baseline, 16 weeks ]

9.  Secondary:   Nausea and Dyspepsia Measured by Visual Analog Scale   [ Time Frame: One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits ]

10.  Secondary:   Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores   [ Time Frame: Baseline and 4 and 8 and 16 weeks ]

11.  Secondary:   Number of Participants With a Hypoglycemic Event   [ Time Frame: Baseline through 4, 8, and 16 weeks ]

12.  Secondary:   Rate of Hypoglycemia Per 30 Days   [ Time Frame: Baseline through 16 weeks ]

13.  Secondary:   Change From Baseline in Lipids   [ Time Frame: Baseline, 16 weeks ]

14.  Secondary:   Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire   [ Time Frame: Baseline and 4 and 8 and 16 weeks ]

15.  Secondary:   Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire   [ Time Frame: Baseline and 4 and 8 and 16 weeks ]

16.  Secondary:   Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)   [ Time Frame: Time zero to 168 hours after study drug administration at 4, 8, and 16 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 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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00630825     History of Changes
Other Study ID Numbers: 12068, H9X-MC-GBCJ
Study First Received: February 28, 2008
Results First Received: October 3, 2014
Last Updated: December 8, 2014
Health Authority: United States: Food and Drug Administration