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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIAD | Other Identifier | Eli Lilly and Company |
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Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine
Prestudy treatment for patients who enter this study will be once daily insulin glargine along with mealtime insulins. Patients will continue to use their mealtime insulins throughout the study. The study will consist of 16 weeks of treatment and 4 weeks of follow-up. The 16 weeks of treatment will consist of two 8-week periods (Periods 1 and 2) during which patients will receive insulin glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence. During the 4-week follow-up period, patients will return to insulin glargine or another basal insulin recommended by the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2605541 First, Then Insulin Glargine | Experimental | Participants received LY2605541 for 8 weeks, followed by insulin glargine for 8 weeks. |
|
| Insulin Glargine First, Then LY2605541 | Active Comparator | Participants received insulin glargine for 8 weeks, followed by LY2605541 for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2605541 | Drug | Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles | It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday & evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis [IA], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin [HbA1c] group); visit; visit and treatment interaction; a random effect for participant. | Week 8 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles | It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday & evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. LS mean of daily Avg. BG is from MMRM, which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; a random effect for participant. |
Not provided
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. | Chula Vista | California | 91911 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15855602 | Background | Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available. | |
| 36542287 | Derived | Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21. |
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This is an open-label, randomized, 2-arm crossover study. The study consisted of two 8-week periods (Periods I and II) during which participants received Glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2605541/Glargine | Participants took LY2605541 in Period I and Glargine in Period II |
| FG001 | Glargine/LY2605541 | Participants took Glargine in Period I and LY2605541 in Period II |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period I |
|
| ||||||||||||||||||||||||
| Period II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2605541/Glargine | Participants took LY2605541 in Period I and Glargine in Period II |
| BG001 | Glargine/LY2605541 | Participants took Glargine in Period I and LY2605541 in Period II |
| 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 | Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles | It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday & evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis [IA], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin [HbA1c] group); visit; visit and treatment interaction; a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | millimole per Liter (mmol/L) | Week 8 of each treatment period |
|
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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 | LY2605541 | Participants took LY2605541 administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urosepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C587357 | LY2605541 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin glargine | Drug | Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods. |
|
| Baseline, Week 8 of each treatment period |
| Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline to 8-week at Period I is from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; interaction between visit and treatment; and a random effect for participant. | Baseline, Week 8 (Period I) |
| Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | Week 8 (Period I) |
| Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I) | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). | Week 8 (Period I) |
| 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint | 8-point SMBG profiles are measured at morning fasting BG (FBG), midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant. | Week 8 of each treatment period |
| Daily Basal Insulin Dose at Week 2 and Week 8 Endpoint | LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant. | Week 2 and Week 8 of each treatment period |
| Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 8 Endpoint | The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches. | Week 8 of each treatment period |
| Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20 | Negative is defined as either 'negative' from lab or percent binding <1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative. | Week 8, Week 16 and Week 20 |
| Percentage of Participants With Hypoglycemia Baseline Through Week 8 | Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole per Liter (mmol/L) (≤70 milligram per deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]. | Baseline through Week 8 of each treatment period |
| Rate of Hypoglycemia Per 30 Days Baseline Through Week 8 | Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]. Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30. | Baseline through Week 8 of each treatment period |
| Glycemic Variability in Fasting Blood Glucose (FBG) at Week 8 Endpoint | Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day between Week 6 and Week 8. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant. | Week 8 of each treatment period |
| 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. | Atlanta | Georgia | 30309 | 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. | Idaho Falls | Idaho | 83404 | 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. | Topeka | Kansas | 66606 | 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. | Metairie | Louisiana | 70006 | 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. | Minneapolis | Minnesota | 55416 | 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. | Austin | Texas | 78731 | 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. | Dallas | Texas | 75230 | 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. | Renton | Washington | 98057 | 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. | Holon | 22100 | Israel |
| 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. | Petah Tikva | 49451 | Israel |
| 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. | Tel Litwinsky | 52661 | Israel |
| 26278063 | Derived | Rosenstock J, Blevins TC, Bergenstal RM, Morrow LA, Qu Y, Jacober SJ. Reduction in short-acting insulin requirement accompanies improved glycemic control with basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes. J Diabetes. 2016 Jan;8(1):166-9. doi: 10.1111/1753-0407.12332. Epub 2015 Nov 17. No abstract available. |
| 23193209 | Derived | Rosenstock J, Bergenstal RM, Blevins TC, Morrow LA, Prince MJ, Qu Y, Sinha VP, Howey DC, Jacober SJ. Better glycemic control and weight loss with the novel long-acting basal insulin LY2605541 compared with insulin glargine in type 1 diabetes: a randomized, crossover study. Diabetes Care. 2013 Mar;36(3):522-8. doi: 10.2337/dc12-0067. Epub 2012 Nov 27. |
| Physician Decision |
|
| Protocol Violation |
|
| Adverse Event |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| LY2605541 |
Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods |
| OG001 | Glargine | Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods |
|
|
|
| Secondary | Change From Baseline in Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles | It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday & evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. LS mean of daily Avg. BG is from MMRM, which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 8 of each treatment period |
|
|
|
|
| Secondary | Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline to 8-week at Period I is from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; interaction between visit and treatment; and a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | percentage of glycated hemoglobin | Baseline, Week 8 (Period I) |
|
|
|
|
| Secondary | Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value, last observation carried forward (LOCF). | Posted | Number | percentage of participants | Week 8 (Period I) |
|
|
|
|
| Secondary | Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I) | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value, last observation carried forward (LOCF). | Posted | Number | percentage of participants | Week 8 (Period I) |
|
|
|
| Secondary | 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint | 8-point SMBG profiles are measured at morning fasting BG (FBG), midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | mmol/L | Week 8 of each treatment period |
|
|
|
|
| Secondary | Daily Basal Insulin Dose at Week 2 and Week 8 Endpoint | LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant. | All randomized participants who took at least one dose of study drug with at least one non-missing value of the response variable at any of the subsequent weeks. | Posted | Least Squares Mean | Standard Deviation | nanomoles per kilogram (nmoles/kg) | Week 2 and Week 8 of each treatment period |
|
|
|
| Secondary | Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 8 Endpoint | The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches. | Participants who took at least one dose of study drug and had measurements at Week 8. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles per liter (pMol/L) | Week 8 of each treatment period |
|
|
|
| Secondary | Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20 | Negative is defined as either 'negative' from lab or percent binding <1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative. | All randomized participants who took at least one dose of study drug with both baseline and endpoint antibody measurements. | Posted | Number | percentage of participants | Week 8, Week 16 and Week 20 |
|
|
|
| Secondary | Percentage of Participants With Hypoglycemia Baseline Through Week 8 | Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole per Liter (mmol/L) (≤70 milligram per deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]. | All randomized participants who took at least one dose of study drug. | Posted | Number | percentage of participants | Baseline through Week 8 of each treatment period |
|
|
|
| Secondary | Rate of Hypoglycemia Per 30 Days Baseline Through Week 8 | Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]. Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30. | All randomized participants who took at least one dose of study drug. | Posted | Mean | Standard Deviation | number of hypoglycemia episodes/30 days | Baseline through Week 8 of each treatment period |
|
|
|
|
| Secondary | Glycemic Variability in Fasting Blood Glucose (FBG) at Week 8 Endpoint | Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day between Week 6 and Week 8. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | Least Squares Mean | Standard Error | mmol/L | Week 8 of each treatment period |
|
|
|
|
| 6 |
| 125 |
| 66 |
| 125 |
| EG001 | Glargine | Participants took Glargine administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks | 4 | 130 | 59 | 130 |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Severe hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| 0.119 |
The statistical significance level is 0.10. P-value is for HbA1c ≤6.5%. |
| 95 |
| Superiority or Other |
| Morning FBG |
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| Morning 2-hr postprandial BG |
|
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| Midday Pre-meal BG |
|
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| Midday 2-hr postprandial BG |
|
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| Evening Pre-meal BG |
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| Evening 2-hr postprandial BG |
|
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| Bed time BG |
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| Mixed Models Analysis |
| 0.464 |
The statistical significance level is 0.10. P-value is for morning FBG. |
| Least Squares Mean Difference (Final) |
| -0.24 |
| Standard Error of the Mean |
| 0.33 |
| 2-Sided |
| 90 |
| -0.79 |
| 0.30 |
| Superiority or Other |
| Mixed Models Analysis | 0.151 | The statistical significance level is 0.10. P-value is for morning 2-hr postprandial BG. | Least Squares Mean Difference (Final) | -0.48 | Standard Error of the Mean | 0.33 | 2-Sided | 90 | -1.04 | 0.07 | Superiority or Other |
| Mixed Models Analysis | 0.079 | The statistical significance level is 0.10. P-value is for midday pre-meal BG. | Least Squares Mean Difference (Final) | -0.54 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | -1.05 | -0.03 | Superiority or Other |
| Mixed Models Analysis | 0.070 | The statistical significance level is 0.10. P-value is for midday 2-hr postprandial BG. | Least Squares Mean Difference (Final) | -0.52 | Standard Error of the Mean | 0.28 | 2-Sided | 90 | -0.99 | -0.05 | Superiority or Other |
| Mixed Models Analysis | 0.008 | The statistical significance level is 0.10. P-value is for evening pre-meal BG. | Least Squares Mean Difference (Final) | -0.86 | Standard Error of the Mean | 0.32 | 2-Sided | 90 | -1.39 | -0.34 | Superiority or Other |
| Mixed Models Analysis | 0.003 | The statistical significance level is 0.10. P-value is for evening 2-hr postprandial BG. | Least Squares Mean Difference (Final) | -0.89 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | -1.38 | -0.41 | Superiority or Other |
| Mixed Models Analysis | 0.001 | The statistical significance level is 0.10. P-value is for bed time BG. | Least Squares Mean Difference (Final) | -1.10 | Standard Error of the Mean | 0.33 | 2-Sided | 90 | -1.64 | -0.55 | Superiority or Other |
| Week 8 |
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| Week 16 (Period II) from negative to positive |
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| Week 16 (Period II) from positive to negative |
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| Week 20 (follow up) from negative to positive |
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| Week 20 (follow up) from positive to negative |
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