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| ID | Type | Description | Link |
|---|---|---|---|
| I2Q-MC-GMAH | Other Identifier | Eli Lilly and Company |
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Terminated due to nonclinical safety findings
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The purpose of this study is to help answer the following questions:
The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 milligrams (mg) Placebo | Placebo Comparator | Participants received 2 placebo capsules by mouth (po), twice daily (BID), prior to morning and evening meals for 12 weeks. |
|
| 100 mg LY2599506 | Experimental | Participants received 50-mg capsules of LY2599506 po BID (One 50 mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks. |
|
| 200 mg LY2599506 | Experimental | Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
|
| 400 mg LY2599506 | Experimental | Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
|
| 200 mg LY2599506 once daily | Experimental | Participants received 200-mg of LY2599506 po once daily (QD) (Two 100 mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered po BID, prior to morning and evening meals for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks | Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks | Measures the QT interval in the ECG. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
| 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. | Topeka | Kansas | 66606 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0 Milligrams (mg) Placebo | Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks. |
| FG001 | 100 mg LY2599506 | Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks. |
| FG002 | 200 mg LY2599506 | Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
| FG003 | 400 mg LY2599506 | Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
| FG004 | 200 mg LY2599506 Once Daily | Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0 Milligrams (mg) Placebo | Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks. |
| BG001 | 100 mg LY2599506 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks | Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, 12 weeks |
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0 Milligrams (mg) Placebo | Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
Since Study GMAH was terminated after enrolling only 78 participants with just 10 participants completing 12 weeks of treatment with LY2599506, only disposition, demographics, and safety data are reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C520311 | glucokinase activator compound 50 |
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| LY2599506 | Drug | Administered po for 12 weeks |
|
|
| Baseline, 12 weeks, 16 weeks |
| Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks | HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed. | Baseline, 12 weeks, 16 weeks |
| Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks | HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed. | Baseline, 12 weeks, 16 weeks |
| Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks | Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline, 12 weeks, 16 weeks |
| Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks | Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Baseline, 12 weeks, 16 weeks |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks | Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBPB minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline, 12 weeks, 16 weeks |
| Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period | Hypoglycemia was defined as any time a participant feels s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 mg/dL (3.9 mmol/L) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline through 16 weeks |
| Change From Baseline in Body Weight at 12 Weeks and 16 Weeks | Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline, 12 weeks, 16 weeks |
| Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks | SMBG levels were measured at the following 7 timepoints during the day: fasting pre-breakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline, 4 weeks, 12 weeks, 16 weeks |
| Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period | Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Baseline through 12 weeks |
| Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period | Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline through 12 weeks |
| Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period | Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented. | Baseline through 12 weeks, Baseline through 16 weeks |
| Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks | DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Baseline, 12 weeks, 16 weeks |
| Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks | Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed. | Baseline, 12 weeks, 16 weeks |
| Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks | Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Baseline, 12 weeks, 16 weeks |
| Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period | The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline through 12 weeks |
| Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506 | The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12 |
| Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506 | The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12 |
| 30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall | Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline through 16 weeks |
| Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks | Heart rate was measured in heartbeats per minute. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Baseline, 12 weeks, 16 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. | Toms River | New Jersey | 08753 | 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. | Syracuse | New York | 13210 | 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 Leonards | New South Wales | 2065 | Australia |
| 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. | Daw Park | South Australia | 5041 | Australia |
| 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. | Box Hill | Victoria | 3128 | Australia |
| 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. | Manati | 00674 | 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. | San Juan | 00907 | 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. | Arkhangelsk | 163045 | Russia |
| 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. | Moscow | 119435 | Russia |
| 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. | Rostov-on-Don | 344022 | Russia |
| 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. | Saint Petersburg | 194354 | Russia |
| 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. | Alicante | 03114 | 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. | Alzira | 46600 | 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. | Dos Hermanas | 41014 | 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. | Santa Cruz de Tenerife | 38320 | Spain |
| Entry Criteria Not Met |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
| BG002 | 200 mg LY2599506 | Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
| BG003 | 400 mg LY2599506 | Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
| BG004 | 200 mg LY2599506 Once Daily | Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks). |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of Diabetes in Years | Mean | Standard Deviation | years |
|
| Percentage of Glycosylated Fraction of Hemoglobin A1c | HbA1c: hemoglobin A1c, glycosylated fraction of hemoglobin A (%) | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| OG001 |
| 100 mg LY2599506 |
Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks. |
| OG002 | 200 mg LY2599506 | Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
| OG003 | 400 mg LY2599506 | Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
| OG004 | 200 mg LY2599506 Once Daily | Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks). |
|
| Secondary | Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks | Measures the QT interval in the ECG. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | The QT interval was not analyzed due to insufficient sample size. | Posted | Mean | Standard Deviation | milliseconds (ms) | Baseline, 12 weeks, 16 weeks |
|
|
| Secondary | Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks | HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed. | HOMA2 (%B) was not calculated due to insufficient sample size. | Posted | Mean | Standard Deviation | percentage of beta cell function (%B) | Baseline, 12 weeks, 16 weeks |
|
|
| Secondary | Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks | HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed. | HOMA2 (%S) was not calculated due to insufficient sample size. | Posted | Mean | Standard Deviation | percentage of insulin sensitivity (%S) | Baseline, 12 weeks, 16 weeks |
|
|
| Secondary | Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks | Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but not presented due to insufficient sample size. | Posted | Mean | Standard Deviation | millimoles per liter (mmoL/L) | Baseline, 12 weeks, 16 weeks |
|
|
| Secondary | Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks | Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Quality of life data were not analyzed due to insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks, 16 weeks |
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks | Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBPB minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 12 weeks, 16 weeks |
|
|
| Secondary | Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period | Hypoglycemia was defined as any time a participant feels s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 mg/dL (3.9 mmol/L) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Number | hypoglycemic episodes | Baseline through 16 weeks |
|
|
| Secondary | Change From Baseline in Body Weight at 12 Weeks and 16 Weeks | Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Mean | Standard Deviation | kilograms (kg) | Baseline, 12 weeks, 16 weeks |
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| Secondary | Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks | SMBG levels were measured at the following 7 timepoints during the day: fasting pre-breakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Baseline, 4 weeks, 12 weeks, 16 weeks |
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| Secondary | Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period | Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Number | percentage of participants | Baseline through 12 weeks |
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| Secondary | Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period | Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Number | percentage of participants | Baseline through 12 weeks |
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| Secondary | Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period | Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented. | Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis. | Posted | Number | percentage of participants | Baseline through 12 weeks, Baseline through 16 weeks |
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| Secondary | Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks | DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Quality of life data were not analyzed due to insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks, 16 weeks |
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| Secondary | Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks | Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed. | Quality of life data were not analyzed due to insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks, 16 weeks |
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| Secondary | Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks | Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Quality of life data were not analyzed due to insufficient sample size. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 weeks, 16 weeks |
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| Secondary | Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period | The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | No participants had data analyzed due to insufficient sample size. | Posted | Mean | Standard Deviation | milligrams (mg) | Baseline through 12 weeks |
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| Secondary | Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506 | The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to the insufficient sample size and the sparse sampling approach. | Posted | Mean | Standard Deviation | nanograms per deciliter (ng/dL) | Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12 |
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| Secondary | Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506 | The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed. | Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach. | Posted | Mean | Standard Deviation | nanograms per milliliter times hour | Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12 |
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| Secondary | 30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall | Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Number | hypoglycemic episodes per 30 days | Baseline through 16 weeks |
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| Secondary | Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks | Heart rate was measured in heartbeats per minute. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented. | Data were reviewed but are not presented due to insufficient sample size. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, 12 weeks, 16 weeks |
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| 0 |
| 22 |
| 4 |
| 22 |
| EG001 | 100 mg LY2599506 | Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks. | 0 | 12 | 4 | 12 |
| EG002 | 200 mg LY2599506 | Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. | 0 | 15 | 1 | 15 |
| EG003 | 400 mg LY2599506 | Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. | 1 | 14 | 8 | 14 |
| EG004 | 200 mg LY2599506 Once Daily | Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks). | 2 | 15 | 6 | 15 |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Adrenal mass | Endocrine disorders | MedDRA 13.0 | Systematic Assessment |
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| Eye swelling | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Premature ageing | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Hepatitis acute | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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Not provided
| D004700 | Endocrine System Diseases |