A Study for Patients With Type 2 Diabetes Mellitus | NCT00804986 | Trialant
NCT00804986
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 14, 2011Estimated
Enrollment
247Actual
Phase
Phase 2
Conditions
Diabetes Mellitus, Type 2
Interventions
LY2428757
Placebo
Countries
United States
Austria
Germany
India
Mexico
Puerto Rico
Romania
South Africa
Spain
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00804986
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12134
Secondary IDs
ID
Type
Description
Link
I1I-MC-GECD
Other Identifier
Eli Lilly and Company
CTRI/2009/091/000091
Registry Identifier
India
Brief Title
A Study for Patients With Type 2 Diabetes Mellitus
Official Title
A 12-Week,Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients With Type 2 Diabetes Mellitus
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jul 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2008
Primary Completion Date
Jan 2010Actual
Completion Date
Jan 2010Actual
First Submitted Date
Dec 8, 2008
First Submission Date that Met QC Criteria
Dec 8, 2008
First Posted Date
Dec 9, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
May 13, 2011
Results First Submitted that Met QC Criteria
May 13, 2011
Results First Posted Date
Jun 15, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 25, 2010
Certification/Extension First Submitted that Passed QC Review
Oct 25, 2010
Certification/Extension First Posted Date
Oct 27, 2010Estimated
Last Update Submitted Date
Jul 12, 2011
Last Update Posted Date
Jul 14, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
247Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
0.5 mg LY2428757
Experimental
Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Drug: LY2428757
2.0 mg LY2428757
Experimental
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Drug: LY2428757
6.2 mg LY2428757
Experimental
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Drug: LY2428757
12.0 mg LY2428757
Experimental
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Drug: LY2428757
17.6 mg LY2428757
Experimental
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2428757
Drug
Once weekly for 12 weeks as a subcutaneous injection.
0.5 mg LY2428757
12.0 mg LY2428757
17.6 mg LY2428757
2.0 mg LY2428757
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint
Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint
The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
Treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
Have a glycosylated fraction of hemoglobin A (HbA1c) value of 7.0% - 10.0% at screening
Women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
Have a body mass index (BMI) between 25 and 40 kilograms per square meters kg/m^2) at screening
Stable weight during the 3 months prior to screening.
Exclusion Criteria:
Use any antidiabetic agent other than metformin during the 2 months prior to screening.
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
Are currently taking prescription or over-the counter medications to promote weight loss.
Have been previously diagnosed with pancreatitis
Women who are breastfeeding.
Have a history of myocardial infarction, unstable angina, coronary artery bypass graft (CABG), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
Have poorly controlled hypertension
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Drug: Placebo
6.2 mg LY2428757
Placebo
Drug
1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.
Placebo
baseline, 12 weeks
Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study
Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.
baseline through 16 weeks
Total Average Concentration (Cavg) of LY2428757
Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).
4 weeks, 6 weeks, 8 weeks, 10 weeks
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint
Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
baseline, 12 weeks
Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
baseline, 12 weeks
Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
baseline, 12 weeks
Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
baseline, 12 weeks
Change in Fasting Lipids From Baseline to Week 12 Endpoint
Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.
baseline, 12 weeks
Change in Fasting Weight From Baseline to Week 12 Endpoint
LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
baseline, 12 weeks
Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint
Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
baseline, 12 weeks
Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint
DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
baseline, 12 weeks
Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint
Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
baseline, 12 weeks
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Baseline, 12 Weeks
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chula Vista
California
91911
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Huntington Beach
California
92648
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Long Beach
California
90806
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pomona
California
91767
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sacramento
California
95825
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Melbourne
Florida
32901
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago
Illinois
60607
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Baltimore
Maryland
21204
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Waltham
Massachusetts
02453
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Louis
Missouri
63141
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Las Vegas
Nevada
89101
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mentor
Ohio
44060
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Spokane
Washington
99220
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vancouver
Washington
98664
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vienna
1090
Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vorarlberg
6800
Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Berlin
12627
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cologne
50931
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamburg
20253
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lübeck
23562
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Magdeburg
39104
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mainz
D-55116
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bangalore
580043
India
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chennai
60004
India
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cooperage
400021
India
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shivājīnagar
411005
India
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Garza García
66260
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guadalajara
44340
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City
10700
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Monterrey
64461
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rio Piedras
00921
Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brasov
500365
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bucharest
010507
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cluj-Napoca
400006
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ploieşti
100163
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Satu Mare
440055
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sf Gheorghe
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Târgu Mureş
540142
Romania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bellville
7531
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Benoni
1500
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kempton Park
1619
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Somerset West
7129
South Africa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Granada
18012
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lleida
25198
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid
28046
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santiago de Compostela
15706
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Valencia
46017
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dnipro
49027
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dnipropetrovsk
49023
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Donetsk
83037
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kharkiv
61048
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kirovograd
25001
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kyiv
02175
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Odesa
65114
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vinnytsia
21010
Ukraine
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bath
Banes
BA1 3NG
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barnsley
S75 2EP
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham
BS 5SS
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Liverpool
L9 7AL
United Kingdom
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
FG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
FG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
FG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
FG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
FG00036 subjects
FG00143 subjects
FG00242 subjects
FG00342 subjects
FG00443 subjects
FG00541 subjects
COMPLETED
FG00035 subjects
FG00135 subjects
FG00240 subjects
FG00334 subjects
FG00434 subjects
FG00531 subjects
NOT COMPLETED
FG0001 subjects
FG0018 subjects
FG0022 subjects
FG0038 subjects
FG0049 subjects
FG00510 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0043 subjects
FG0050 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0033 subjects
FG004
Inclusion/Exclusion criteria not met
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
BG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
BG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
BG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
BG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
BG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00036
BG00143
BG00242
BG00342
BG00443
BG00541
BG006247
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.5± 8.06
BG00154.6± 8.33
BG00256.4± 8.07
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00120
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0002
BG0014
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00011
BG00117
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
percentage of glycosylated hemoglobin
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
p-value represents change from baseline to Week 12 HbA1c for 0.5 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.
Difference in mean change from baseline
-0.47
2-Sided
95
-0.83
-0.11
No
Superiority or Other
Secondary
Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint
The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.
Posted
Least Squares Mean
Standard Error
millimeters (mm)
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
Secondary
Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study
Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.
All randomized participants
Posted
Number
participants
baseline through 16 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Secondary
Total Average Concentration (Cavg) of LY2428757
Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).
All randomized participants
Posted
Number
nanograms per milliliter (ng/mL)
4 weeks, 6 weeks, 8 weeks, 10 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
Secondary
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint
Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
milligrams per deciliter (mg/dL)
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Secondary
Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
milligrams per minute per deciliter
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Secondary
Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
picomole per minute per liter
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Secondary
Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
picomole per minute per liter
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Secondary
Change in Fasting Lipids From Baseline to Week 12 Endpoint
Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. The last post-baseline measurement was carried forward if the value at week 12 was missing.
Posted
Least Squares Mean
Standard Error
millimole per liter (mmol/L)
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Secondary
Change in Fasting Weight From Baseline to Week 12 Endpoint
LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.
Posted
Least Squares Mean
95% Confidence Interval
kilograms (kg)
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Secondary
Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint
Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)
Posted
Least Squares Mean
Standard Error
units on a scale
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
Secondary
Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint
DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)
Posted
Least Squares Mean
Standard Error
units on a scale
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Secondary
Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint
Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)
Posted
Least Squares Mean
Standard Error
millimeters
baseline, 12 weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Secondary
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Posted
Number
percentage of participants
Baseline, 12 Weeks
ID
Title
Description
OG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Time Frame
Not provided
Description
The safety population includes all randomized participants who received at least one administration of study medication.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1
36
19
36
EG001
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
4
42
25
42
EG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1
42
26
42
EG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1
41
24
41
EG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
0
43
28
43
EG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
0
40
23
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG0031 events1 affected41 at risk
EG0040 events0 affected43 at risk
EG0050 events0 affected40 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG0030 events0 affected41 at risk
EG0040 events0 affected43 at risk
EG0050 events0 affected40 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Tympanic membrane disorder
Ear and labyrinth disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Vision blurred
Eye disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Visual disturbance
Eye disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0022 events2 affected42 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Abdominal rigidity
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0022 events2 affected42 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0003 events3 affected36 at risk
EG0013 events3 affected42 at risk
EG0027 events4 affected42 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0025 events3 affected42 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0002 events1 affected36 at risk
EG0016 events6 affected42 at risk
EG00221 events9 affected42 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Asthenia
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Chest pain
General disorders
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Cyst rupture
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Early satiety
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Fatigue
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Injection site bruising
General disorders
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Injection site haematoma
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Injection site irritation
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Injection site pain
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Injection site pruritus
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Injection site reaction
General disorders
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0011 events1 affected42 at risk
EG0022 events1 affected42 at risk
EG003
Local swelling
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Malaise
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Oedema peripheral
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Pyrexia
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Thirst
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Ear infection
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Influenza
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0022 events2 affected42 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0022 events2 affected42 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0012 events2 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Blood calcitonin increased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Blood calcium increased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Blood glucose increased
Investigations
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Blood pressure increased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Blood urine present
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Lipase increased
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Protein urine
Investigations
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA 11
Systematic Assessment
EG0002 events1 affected36 at risk
EG0012 events2 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0013 events2 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0002 events2 affected36 at risk
EG0012 events2 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0013 events3 affected42 at risk
EG0022 events2 affected42 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0002 events2 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events2 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected42 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events1 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 11
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected42 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
p-value represents change from baseline to week 12 HbA1c for 2.0 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.
p-value represents change from baseline to Week 12 HbA1c for 6.2 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.
p-value represents change from baseline to Week 12 HbA1c for 12.0 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.
p-value represents change from baseline to Week 12 HbA1c for 17.6 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.
Difference in mean change from baseline
-1.24
2-Sided
95
-1.59
-0.88
No
Superiority or Other
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
p-value represents change from baseline to Week 12 for how full, 17.6 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-6.02
95
No
Superiority or Other
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Units
Counts
Participants
OG00036
OG00143
OG00242
OG00342
OG00443
OG00541
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0021
OG0033
OG0042
OG0051
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Units
Counts
Participants
OG00034
OG00134
OG00239
OG00332
OG00435
OG00532
Title
Denominators
Categories
Title
Measurements
OG00029.5
OG001118
OG002453
OG003877
OG0041290
OG0050
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
p-value represents change from baseline to Week 12 for prior to bed glucose, 17.6 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-53.16
95
No
Superiority or Other
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
p-value represents change from baseline to Week 12 total glucose AUC for 17.6 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-7786.69
95
No
Superiority or Other
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Units
Counts
Participants
OG00023
OG00123
OG00232
OG00323
OG00427
OG00527
Title
Denominators
Categories
Title
Measurements
OG0003111.25(-4046.98 to 10269.49)
OG0013984.37(-3119.75 to 11088.50)
OG00212521.89(6225.80 to 18817.99)
OG00314179.28(6829.94 to 21528.62)
OG0048778.23(2213.32 to 15343.14)
OG0053540.52(-3092.57 to 10173.62)
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Units
Counts
Participants
OG00029
OG00127
OG00233
OG00327
OG00430
OG00530
Title
Denominators
Categories
Title
Measurements
OG000-683.72(-27307.99 to 25940.55)
OG00131434.85(4250.94 to 58618.75)
OG00249370.53(24438.17 to 74302.88)
OG00346280.14(18616.52 to 73943.75)
OG00422012.58(-3998.13 to 48023.29)
OG0058714.30(-17322.91 to 34751.50)
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Units
Counts
Participants
OG00035
OG00140
OG00240
OG00337
OG00441
OG00537
Title
Denominators
Categories
Triglycerides (n=35, 40, 40, 37, 41, 37)
Title
Measurements
OG000-0.15± 0.139
OG0010.08± 0.130
OG002-0.35± 0.130
OG003-0.31± 0.135
OG004-0.31± 0.128
OG005-0.22± 0.135
HDL (n=35, 38, 39, 31, 39, 34)
Title
Measurements
OG0000.02± 0.034
OG001-0.03± 0.032
OG002-0.03± 0.032
OG003
LDL (n=35, 37, 39, 31, 39, 34)
Title
Measurements
OG0000.0± 0.09
OG001-0.1± 0.09
OG002-0.1± 0.09
OG003
Total cholesterol (n=35, 38, 39, 31, 39, 34)
Title
Measurements
OG000-0.10± 0.104
OG001-0.01± 0.100
OG002-0.30± 0.098
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
ANCOVA
ANCOVA: baseline and treatment
0.693
p-value represents change from baseline to Week 12 for fasting triglycerides, 0.5 mg treatment arm in comparison to placebo
Difference in mean change from baseline
0.08
95
No
Superiority or Other
OG001
OG005
ANCOVA
ANCOVA: baseline and treatment
0.104
p-value represents change from baseline to Week 12 for fasting triglycerides, 2.0 mg treatment arm in comparison to placebo
Difference in mean change from baseline
0.31
95
No
Superiority or Other
OG002
OG005
ANCOVA
ANCOVA: baseline and treatment
0.506
p-value represents change from baseline to Week 12 for fasting triglycerides, 6.2 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.13
95
No
Superiority or Other
OG003
OG005
ANCOVA
ANCOVA: baseline and treatment
0.648
p-value represents change from baseline to Week 12 for fasting triglycerides, 12.0 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.09
95
No
Superiority or Other
OG004
OG005
ANCOVA
ANCOVA: baseline and treatment
0.647
p-value represents change from baseline to Week 12 for fasting triglycerides, 17.6 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.09
95
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA: baseline and treatment
0.781
p-value represents change from baseline to Week 12 for fasting HDL, 0.5 mg treatment arm in comparison to placebo
Difference in mean change from baseline
0.01
95
No
Superiority or Other
OG001
OG005
ANCOVA
ANCOVA: baseline and treatment
0.401
p-value represents change from baseline to Week 12 for fasting HDL, 2.0 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.04
95
No
Superiority or Other
OG002
OG005
ANCOVA
ANCOVA: baseline and treatment
0.464
p-value represents change from baseline to Week 12 for fasting HDL, 6.2 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.03
95
No
Superiority or Other
OG003
OG005
ANCOVA
ANCOVA: baseline and treatment
0.420
p-value represents change from baseline to Week 12 for fasting HDL, 12.0 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.04
95
No
Superiority or Other
OG004
OG005
ANCOVA
ANCOVA: baseline and treatment
0.762
p-value represents change from baseline to Week 12 for fasting HDL, 17.6 mg treatment arm in comparison to placebo
Difference in mean change from baseline
0.01
95
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA: baseline and treatment
0.738
p-value represents change from baseline to Week 12 for fasting LDL, 0.5 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.04
95
No
Superiority or Other
OG001
OG005
ANCOVA
ANCOVA: baseline and treatment
0.277
p-value represents change from baseline to Week 12 for fasting LDL, 2.0 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.14
95
No
Superiority or Other
OG002
OG005
ANCOVA
ANCOVA: baseline and treatment
0.094
p-value represents change from baseline to Week 12 for fasting LDL, 6.2 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.21
95
No
Superiority or Other
OG003
OG005
ANCOVA
ANCOVA: baseline and treatment
0.792
p-value represents change from baseline to Week 12 for fasting LDL, 12.0 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.04
95
No
Superiority or Other
OG004
OG005
ANCOVA
ANCOVA: baseline and treatment
0.105
p-value represents change from baseline to Week 12 for fasting LDL, 17.6 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.21
95
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA: baseline and treatment
0.403
p-value represents change from baseline to Week 12 for fasting total cholesterol, 0.5 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.12
95
No
Superiority or Other
OG001
OG005
ANCOVA
ANCOVA: baseline and treatment
0.799
p-value represents change from baseline to Week 12 for fasting total cholesterol, 2.0 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.04
95
No
Superiority or Other
OG002
OG005
ANCOVA
ANCOVA: baseline and treatment
0.029
p-value represents change from baseline to Week 12 for fasting total cholesterol, 6.2 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.32
95
No
Superiority or Other
OG003
OG005
ANCOVA
ANCOVA: baseline and treatment
0.439
p-value represents change from baseline to Week 12 for fasting total cholesterol, 12.0 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.12
95
No
Superiority or Other
OG004
OG005
ANCOVA
ANCOVA: baseline and treatment
0.062
p-value represents change from baseline to Week 12 for fasting total cholesterol, 17.6 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-0.27
95
No
Superiority or Other
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
p-value represents change from baseline to Week 12 for fasting weight, 17.6 mg treatment arm in comparison to placebo
Difference in mean change from baseline
-2.01
95
No
Superiority or Other
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Units
Counts
Participants
OG00035
OG00139
OG00240
OG00338
OG00440
OG00537
Title
Denominators
Categories
Title
Measurements
OG0000.2± 0.22
OG001-0.1± 0.20
OG0020.3± 0.21
OG0030.2± 0.21
OG0040.1± 0.21
OG0050.2± 0.21
OG002
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Units
Counts
Participants
OG00035
OG00139
OG00240
OG00337
OG00440
OG00538
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 0.30
OG001-0.1± 0.28
OG002-0.9± 0.28
OG003-0.4± 0.29
OG004-0.3± 0.29
OG005-0.7± 0.28
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Units
Counts
Participants
OG00035
OG00139
OG00240
OG00338
OG00440
OG00537
Title
Denominators
Categories
Title
Measurements
OG0006.9± 2.59
OG0016.2± 2.33
OG0026.0± 2.41
OG0036.0± 2.46
OG0047.1± 2.47
OG0052.7± 2.48
OG003
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG004
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
OG005
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.