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Antihyperglycemic Medications

Phase 3

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Mar 15, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment388

FDA Designations

No designations recorded

Clinical trial landscape

Antihyperglycemic Medications · 1 trial · 1 indication

Phase 3 1
NCT01894568A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin TreatmentType 2 Diabetes Mellitus
COMPLETED388 Analytics
PHASE3COMPLETED
A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)
Baseline, Week 26

Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein \[LDL-C\], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.

Secondary Endpoints

30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Baseline to Week 26
Fasting Serum Glucose (FSG)
Weeks 0 and 26
Fasting Blood Glucose (FBG)
Weeks 0 and 26
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin PeglisproEXPERIMENTALInsulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs).
Insulin GlargineACTIVE_COMPARATORInsulin Glargine administered SC once daily for 26 weeks in combination with OAMs.

Interventions

NameTypeDescription
Insulin PeglisproDRUGAdministered SC using a prefilled pen.
Insulin GlargineDRUGAdministered SC using a prefilled pen
Oral Antihyperglycemic Medications (OAMs)DRUGAdministered orally
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin * Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening * Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to centr...

Countries:JapanSouth KoreaTaiwan
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Frequently asked questions about Antihyperglycemic Medications

What is Antihyperglycemic Medications used for in Type 2 Diabetes Mellitus?

Antihyperglycemic Medications is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 3 clinical development, meaning it has not yet been approved and is still being studied to determine its safety and effectiveness in patients.

Who makes Antihyperglycemic Medications?

Antihyperglycemic Medications is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate this investigational drug for the treatment of Type 2 Diabetes Mellitus.

What phase is Antihyperglycemic Medications in?

Antihyperglycemic Medications is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial for this drug has been completed, and it is being studied for the treatment of Type 2 Diabetes Mellitus.

What clinical trials is Antihyperglycemic Medications in?

Antihyperglycemic Medications has one completed Phase 3 clinical trial with the identifier NCT01894568. The trial, titled 'A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment,' enrolled 388 participants with Type 2 Diabetes Mellitus in Japan, South Korea, and Taiwan.

Is Antihyperglycemic Medications the same as Insulin Peglispro?

Antihyperglycemic Medications is the drug being studied in a clinical trial that compares Insulin Peglispro with Insulin Glargine. The trial is evaluating these treatments as basal insulin therapy for Type 2 Diabetes Mellitus, but the drug name Antihyperglycemic Medications refers to the class of medications being investigated.