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| ID | Type | Description | Link |
|---|---|---|---|
| I8H-MC-BDCM | Other Identifier | Eli Lilly and Company |
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The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3209590 Algorithm 1 | Experimental | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 milligram per deciliter (mg/dL). |
|
| LY3209590 Algorithm 2 | Experimental | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL. |
|
| Insulin Degludec | Active Comparator | Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3209590 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c | HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate. | Baseline, Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c Compared to Insulin Degludec | HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate. |
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Inclusion Criteria:
Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):
HbA1c value of 6.5% to 10%, inclusive
Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive
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 - 5hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates, Inc. | Birmingham | Alabama | 35205 | United States | ||
| Arkansas Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36758572 | Derived | Frias J, Chien J, Zhang Q, Chigutsa E, Landschulz W, Syring K, Wullenweber P, Haupt A, Kazda C. Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study. Lancet Diabetes Endocrinol. 2023 Mar;11(3):158-168. doi: 10.1016/S2213-8587(22)00388-6. Epub 2023 Feb 6. |
| Label | URL |
|---|---|
| A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY3209590 Algorithm 1 | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL. |
| FG001 | LY3209590 Algorithm 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2018 | Feb 10, 2021 |
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| Insulin Degludec |
| Drug |
Administered SC |
|
| Baseline, Week 32 |
| Change From Baseline in Fasting Glucose | Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry, HbA1c strata [<8.5% or ≥8.5%]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate. | Baseline, Week 32 |
| Change From Baseline in Insulin Dose (LY3209590) | The baseline for both LY3209590 arms was the first regular weekly dose at Week 1. | Week 1, Week 32 |
| Change From Baseline in Insulin Dose (Insulin Degludec) | Change from Baseline in Insulin Dose for Insulin Degludec arm was reported. | Baseline, Week 32 |
| Rate of Total Documented Symptomatic Hypoglycemia | The hypoglycemia events were defined by participant reported events with glucose ≤54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants. | Baseline through week 32 |
| Change From Baseline in Body Weight | Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate. | Baseline, Week 32 |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 | PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value. | Week 32 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States |
| AMCR Institute INC | Escondido | California | 92025 | United States |
| Valley Endocrine, Fresno | Fresno | California | 93720 | United States |
| Marin Endocrine Associates | Greenbrae | California | 94904 | United States |
| National Research Institute | Huntington Park | California | 90255 | United States |
| First Valley Medical Group | Lancaster | California | 93534 | United States |
| National Research Institute | Los Angeles | California | 90057 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| ALL Medical Research, LLC | Cooper City | Florida | 33024 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| Metabolic Research Institute Inc. | West Palm Beach | Florida | 33401 | United States |
| East West Medical Institute | Honolulu | Hawaii | 96814 | United States |
| Elite Clinical Trials LLLP | Blackfoot | Idaho | 83221 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Iderc, P.L.C. | West Des Moines | Iowa | 50265 | United States |
| Cotton O'Neil Diabetes and Endocrinology Center | Topeka | Kansas | 66606 | United States |
| Endocrine and Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| NECCR PrimaCare Research, LLC | Fall River | Massachusetts | 02721 | United States |
| Palm Research Center | Las Vegas | Nevada | 89128 | United States |
| Palm Research Center | Las Vegas | Nevada | 89148 | United States |
| Southern New Hampshire Diabetes and Endocrinology | Nashua | New Hampshire | 03063 | United States |
| Metrolina Internal Medicine, P.A. | Charlotte | North Carolina | 28207 | United States |
| Intend Research | Norman | Oklahoma | 73069 | United States |
| The Corvallis Clinic P.C. | Corvallis | Oregon | 97330 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Preferred Primary Care Physicians - Jacob Murphy Lane | Uniontown | Pennsylvania | 15401 | United States |
| Internal Medicine Associates of Anderson | Anderson | South Carolina | 29621 | United States |
| The Research Center of the Upstate | Mauldin | South Carolina | 29662 | United States |
| Texas Diabetes and Endocrinology | Austin | Texas | 78731-4309 | United States |
| Dallas Diabetes Endocrine Center | Dallas | Texas | 75230 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Confluence Health Clinical Research Department | Wenatchee | Washington | 98801 | United States |
| Hospital Universitario UANL | Monterrey | Nuevo León | 64460 | Mexico |
| Investigacion en Salud y Metabolismo S.C | Chihuahua City | 31217 | Mexico |
| Advanced Clinical Research, LLC | Bayamón | PR | 00961 | Puerto Rico |
| Manati Center for Clinical Research Inc | Manati | PR | 00674 | Puerto Rico |
| GCM Medical Group PSC | San Juan | PR | 00917 | Puerto Rico |
| Martha Gomez Cuellar M.D. | San Juan | PR | 00921 | Puerto Rico |
| Centro de Endocrinologia del Este | Yabucoa | 00767 | Puerto Rico |
Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL. |
| FG002 | Insulin Degludec | Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY3209590 Algorithm 1 | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 milligram mg.dL |
| BG001 | LY3209590 Algorithm 2 | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL. |
| BG002 | Insulin Degludec | Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
| |||||||||||||||
| Haemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Mean | Standard Deviation | HbA1C percentage (%) |
|
| 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 HbA1c | HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate. | The data after using rescue medication or stopping study medication were censored. Participants with non-missing baseline value and at least one post baseline value of response were included. | Posted | Least Squares Mean | Standard Error | HbA1C % | Baseline, Week 32 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HbA1c Compared to Insulin Degludec | HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry), visit and treatment by visit interaction, and baseline HbA1c as the covariate. | The data after using rescue medication or stopping study medication were excluded. Participants with non-missing baseline value and at least one post baseline value of response were included. | Posted | Least Squares Mean | Standard Error | HbA1C % | Baseline, Week 32 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Glucose | Change from baseline in fasting glucose was analysed by MMRM including fixed effects of treatment, stratification factors (country, BMI group [> 30 or ≤ 30], sulfonylureas use at study entry, HbA1c strata [<8.5% or ≥8.5%]), visit and treatment by visit interaction, and baseline fasting glucose as the covariate. | The data after using rescue medication or stopping study medication were excluded. Participants with non-missing baseline value and at least one post baseline value of response were included. | Posted | Least Squares Mean | Standard Error | Milligram per deicliter (mg/dL) | Baseline, Week 32 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Insulin Dose (LY3209590) | The baseline for both LY3209590 arms was the first regular weekly dose at Week 1. | Participants with non-missing value at the specified timepoint were included.The data after using rescue medication or stopping study medication were excluded. | Posted | Mean | Standard Deviation | Milligrams (mg) | Week 1, Week 32 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Insulin Dose (Insulin Degludec) | Change from Baseline in Insulin Dose for Insulin Degludec arm was reported. | Participants with non-missing value at the specified timepoint were included.The data after using rescue medication or stopping study medication were excluded. | Posted | Mean | Standard Deviation | International Units (IU) | Baseline, Week 32 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Total Documented Symptomatic Hypoglycemia | The hypoglycemia events were defined by participant reported events with glucose ≤54 mg/dL (3.0 millimole per liter (mmol/L)). Relative Rate was calculated based on Group Mean. Group Mean was estimated by first taking the inverse link function on individual patient covariates, then averaging over all participants. | All randomized study participants who received at least one dose of study medication and had evaluable hypoglycaemic data. | Posted | Mean | Standard Error | Events per participant per year | Baseline through week 32 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight | Change from baseline in body weight was analysed by MMRM including fixed effects of treatment, visit and treatment by visit interaction, and baseline body weight as the covariate. | All randomized participants who received at least one dose of study medication and with non-missing baseline value and at least one post baseline value of response were included. | Posted | Least Squares Mean | Standard Error | Kilogram (kg) | Baseline, Week 32 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 | PK: AUC of LY3209590 was reported for LY3209590 Algorithm 1 and LY3209590 Algorithm 2 arms. AUC was calculated for individual participants using the participant's Week 32 LY3209590 dose amount and the participant's estimated clearance value. | All randomized participants who received at least one dose of LY3209590 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole * hour per Liter (nmol * hr/L) | Week 32 |
|
|
Up to 37 weeks
All randomized participants.
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 | LY3209590 Algorithm 1 | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of <140 mg/dL. | 1 | 135 | 7 | 135 | 17 | 135 |
| EG001 | LY3209590 Algorithm 2 | Participants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of <120 mg/dL. | 0 | 132 | 8 | 132 | 29 | 132 |
| EG002 | Insulin Degludec | Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%. | 1 | 132 | 10 | 132 | 13 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2020 | Feb 10, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571886 | insulin degludec |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Mexico |
|
| <0.001 |
P-value reported is within group comparison between Week 32 and baseline. |
| Equivalence |
Equivalence margin is zero. |
| Mixed Models Analysis | <0.001 | P-value reported is within group comparison between Week 32 and baseline. | Equivalence | Equivalence margin is zero. |
| Insulin Degludec |
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%. |
|
|
|
Participants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C <7%. |
|
|
|
|
|
|
|
|
| Participants |
|
|