Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin
| Verified date | March 2020 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 399 |
| Est. completion date | February 18, 2020 |
| Est. primary completion date | February 18, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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): - dipeptidyl peptidase-4 (DPP-4) inhibitors - sodium-glucose cotransporter (SGLT-2) inhibitors - biguanides - alpha-glucosidase inhibitors - sulfonlyureas - 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: - Type 1 diabetes mellitus or latent autoimmune diabetes - Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening - Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke) - Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease - Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2 - Active or untreated malignancy - Chronic (>14 days) systemic glucocorticoid therapy |
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Investigacion en Salud y Metabolismo S.C | Chihuahua | |
| Mexico | Hospital Universitario UANL | Monterrey | Nuevo León |
| Puerto Rico | Advanced Clinical Research, LLC | Bayamon | |
| Puerto Rico | Manati Center for Clinical Research Inc | Manati | |
| Puerto Rico | GCM Medical Group PSC | San Juan | |
| Puerto Rico | Martha Gomez Cuellar M.D. | San Juan | |
| Puerto Rico | Centro de Endocrinologia del Este | Yabucoa | |
| United States | Internal Medicine Associates of Anderson | Anderson | South Carolina |
| United States | Texas Diabetes and Endocrinology | Austin | Texas |
| United States | Central Research Associates, Inc. | Birmingham | Alabama |
| United States | Elite Clinical Trials LLLP | Blackfoot | Idaho |
| United States | Metrolina Internal Medicine, P.A. | Charlotte | North Carolina |
| United States | John Muir Physician Network Clinical Research Center | Concord | California |
| United States | ALL Medical Research, LLC | Cooper City | Florida |
| United States | The Corvallis Clinic P.C. | Corvallis | Oregon |
| United States | Dallas Diabetes Endocrine Center | Dallas | Texas |
| United States | AMCR Institute INC | Escondido | California |
| United States | NECCR PrimaCare Research, LLC | Fall River | Massachusetts |
| United States | Valley Endocrine, Fresno | Fresno | California |
| United States | Marin Endocrine Associates | Greenbrae | California |
| United States | East West Medical Institute | Honolulu | Hawaii |
| United States | National Research Institute | Huntington Park | California |
| United States | Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho |
| United States | First Valley Medical Group | Lancaster | California |
| United States | Palm Research Center | Las Vegas | Nevada |
| United States | Palm Research Center | Las Vegas | Nevada |
| United States | Arkansas Clinical Research | Little Rock | Arkansas |
| United States | National Research Institute | Los Angeles | California |
| United States | Manassas Clinical Research Center | Manassas | Virginia |
| United States | The Research Center of the Upstate | Mauldin | South Carolina |
| United States | Southern New Hampshire Diabetes and Endocrinology | Nashua | New Hampshire |
| United States | Suncoast Clinical Research | New Port Richey | Florida |
| United States | Intend Research | Norman | Oklahoma |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Rainier Clinical Research Center | Renton | Washington |
| United States | Endocrine and Metabolic Consultants | Rockville | Maryland |
| United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
| United States | Cotton O'Neil Diabetes and Endocrinology Center | Topeka | Kansas |
| United States | University Clinical Investigators, Inc. | Tustin | California |
| United States | Preferred Primary Care Physicians - Jacob Murphy Lane | Uniontown | Pennsylvania |
| United States | Chase Medical Research, LLC | Waterbury | Connecticut |
| United States | Confluence Health Clinical Research Department | Wenatchee | Washington |
| United States | Iderc, P.L.C. | West Des Moines | Iowa |
| United States | Metabolic Research Institute Inc. | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Mexico, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. |
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. |
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. | 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. | 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. | 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. | 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. | 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. | Week 32 |
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