Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDD | Other Identifier | Eli Lilly and Company | |
| 2012-005174-56 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to compare the effect of a double dose of a study drug known as insulin peglispro to a double dose of insulin glargine in participants who have type 2 diabetes. Participants will be treated with study insulin daily, in two 4-week study periods. Each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Peglispro | Experimental | Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. |
|
| Insulin Glargine | Experimental | Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Peglispro | Drug | Administered SQ |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinically Significant Hypoglycemia | The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 milligrams per deciliter (mg/dL) (3.0 millimole per liter [mmol/L]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100. | Predose to 84 Hours Post Double Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose | The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 mg/dL (3.0 mmol/L) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100. | Predose to 12 Hours Post Double Dose |
Not provided
Inclusion Criteria:
Have type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO) classification, for ≥1 year.
Use any type of basal insulin (except degludec), including once-or twice-daily human insulin neutral protamine Hagedom (NPH), insulin detemir, or insulin glargine.
Have hemoglobin A1c (HbA1c) levels ≤9.0% according to local laboratory testing at screening.
Have body mass index (BMI) ≤40.0 kilograms/square meter (kg/m^2).
Have been treated with stable doses of insulin for at least 30 days before screening with:
If on metformin, thiazolidinediones (TZDs), sodium glucose co-transporter 2 (SGLT-2) inhibitors, or dipeptidyl peptidase (DPP4) inhibitors, must be on stable doses for the last 30 days.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research Inc | 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. |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Peglispro/Insulin Glargine | Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. |
| FG001 | Insulin Glargine/Insulin Peglispro | Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period 1 |
|
| ||||||||||||||||||||||||
| Study Period 2 (Crossover) |
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Peglispro/Insulin Glargine | Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. |
| 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 | Percentage of Participants With Clinically Significant Hypoglycemia | The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 milligrams per deciliter (mg/dL) (3.0 millimole per liter [mmol/L]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100. | All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis. | Posted | Number | percentage of participants | Predose to 84 Hours Post Double Dose |
|
Not provided
All participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Peglispro | Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000621851 | basal insulin peglispro |
| C587357 | LY2605541 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin Glargine | Drug | Administered SQ |
|
| Percentage of Participants With Hypoglycemia | The percentage was calculated by dividing the number of participants with hypoglycemia events defined as blood glucose ≤70 mg/dL (3.9 mmol/L) by the total number of participants analyzed, multiplied by 100. | Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose |
| Nadir Glucose | Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | Predose to 84 Hours Post Double Dose |
| Time to the Nadir Glucose | Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). The average time was calculated by dividing the sum of time from double dose to the nadir glucose for participants with blood glucose ≤70 mg/dL (3.9 mmol/L) by the number of participants with blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose. | Predose to 84 Hours Post Double Dose |
| Duration of Glucose ≤70 mg/dL | The duration in minutes of each hypoglycemia episode with glucose ≤70 mg/dL (3.9 mmol/L) was calculated from start time to end time. The duration for a participant was the sum of the durations over the multiple hypoglycemia episodes. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | Predose to 84 Hours Post Double Dose |
| Fasting Blood Glucose | Fasting blood glucose (FBG) was measured by self-monitored blood glucose. LS means were calculated by MMRM analysis with fixed effects of treatment, dosing day, sequence, period, interaction of treatment and dosing day, baseline basal insulin dose stratification factor, and baseline FBG. | Day 1, Day 2, and Day 3 Following Double Dose |
| Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) | Glucose AUC within 3 hours after each meal assessed by the AUC of glucose from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | Preprandial to 3 Hours Postprandial during the day following the standard dose |
| Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion | Glucose AUC excursion within 3 hours after each meal assessed by the AUC of adjusted glucose (= observed glucose - preprandial glucose) from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | Preprandial to 3 Hours Postprandial during the day following the standard dose |
| Beta Cell Function | Beta cell function assessed by the change between pre meal tolerance test and 30 minutes post meal tolerance test in C-peptide corrected insulin/Glucose (ΔC-peptide corrected insulin/ΔGlucose). LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | 0-30 minutes during the meal tolerance test on the day following the standard dose |
| Mainz |
| 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. | Neuss | 41460 | Germany |
| NOT COMPLETED |
|
|
| BG001 | Insulin Glargine/Insulin Peglispro | Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | Insulin Glargine | Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. |
|
|
| Secondary | Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose | The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 mg/dL (3.0 mmol/L) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100. | All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis. | Posted | Number | percentage of participants | Predose to 12 Hours Post Double Dose |
|
|
|
| Secondary | Percentage of Participants With Hypoglycemia | The percentage was calculated by dividing the number of participants with hypoglycemia events defined as blood glucose ≤70 mg/dL (3.9 mmol/L) by the total number of participants analyzed, multiplied by 100. | All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis. | Posted | Number | percentage of participants | Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose |
|
|
|
| Secondary | Nadir Glucose | Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | All randomized participants who received the double dose of study drug and had blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose were included in the analysis. | Posted | Least Squares Mean | Standard Error | mg/dL | Predose to 84 Hours Post Double Dose |
|
|
|
| Secondary | Time to the Nadir Glucose | Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). The average time was calculated by dividing the sum of time from double dose to the nadir glucose for participants with blood glucose ≤70 mg/dL (3.9 mmol/L) by the number of participants with blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose. | All randomized participants who received the double dose of study drug and had blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose were included in the analysis. | Posted | Mean | Standard Deviation | hours | Predose to 84 Hours Post Double Dose |
|
|
|
| Secondary | Duration of Glucose ≤70 mg/dL | The duration in minutes of each hypoglycemia episode with glucose ≤70 mg/dL (3.9 mmol/L) was calculated from start time to end time. The duration for a participant was the sum of the durations over the multiple hypoglycemia episodes. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis. | Posted | Least Squares Mean | Standard Error | Minutes per participant | Predose to 84 Hours Post Double Dose |
|
|
|
| Secondary | Fasting Blood Glucose | Fasting blood glucose (FBG) was measured by self-monitored blood glucose. LS means were calculated by MMRM analysis with fixed effects of treatment, dosing day, sequence, period, interaction of treatment and dosing day, baseline basal insulin dose stratification factor, and baseline FBG. | All randomized participants who received the double dose of study drug and had evaluable fasting blood glucose data were included in the analysis. | Posted | Least Squares Mean | Standard Error | mg/dL | Day 1, Day 2, and Day 3 Following Double Dose |
|
|
|
| Secondary | Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) | Glucose AUC within 3 hours after each meal assessed by the AUC of glucose from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | All randomized participants who received at least one dose of study drug and had evaluable glucose data were included in the analysis. | Posted | Least Squares Mean | Standard Error | mg/dL*h | Preprandial to 3 Hours Postprandial during the day following the standard dose |
|
|
|
| Secondary | Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion | Glucose AUC excursion within 3 hours after each meal assessed by the AUC of adjusted glucose (= observed glucose - preprandial glucose) from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | All randomized participants who received at least one dose of study drug and had evaluable glucose data were included in the analysis. | Posted | Least Squares Mean | Standard Error | mg/dL*h | Preprandial to 3 Hours Postprandial during the day following the standard dose |
|
|
|
| Secondary | Beta Cell Function | Beta cell function assessed by the change between pre meal tolerance test and 30 minutes post meal tolerance test in C-peptide corrected insulin/Glucose (ΔC-peptide corrected insulin/ΔGlucose). LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. | All randomized participants who received at least one dose of study drug and had evaluable ΔC-peptide data were included in the analysis. | Posted | Least Squares Mean | Standard Error | mmol/L | 0-30 minutes during the meal tolerance test on the day following the standard dose |
|
|
|
| 2 |
| 64 |
| 31 |
| 64 |
| EG001 | Insulin Glargine | Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. | 1 | 67 | 26 | 67 |
| Otitis media | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Day 2 |
|
|
| Day 3 |
|
|
| Lunch |
|
|
| Dinner |
|
|
| Lunch |
|
|
| Dinner |
|
|