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Glucotrol

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Novartis AG|Last Updated: Mar 28, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Glucotrol · 2 trials · 1 indication

Phase 1 2
NCT00947024To Demonstrate the Effect of Food on the Bioavailability of GlipizideType 2 Diabetes
COMPLETED18 Analytics
NCT00946504To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol TabletsType 2 Diabetes
COMPLETED28 Analytics
PHASE1COMPLETED
To Demonstrate the Effect of Food on the Bioavailability of Glipizide
Type 2 Diabetes
NCT0094702418
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PHASE1COMPLETED
To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets
Type 2 Diabetes
NCT0094650428
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Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
15 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.
3ACTIVE_COMPARATOR10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.
2EXPERIMENTAL10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.

Interventions

NameTypeDescription
10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.DRUG -
10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.DRUG -
10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.DRUG -
Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)DRUG -
Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)DRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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Competitive Landscape -Type 2 Diabetes 140 trials

Top 20 of 31 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY13PHASE3Retatrutide, Semaglutide
Amgen Inc.AMGN4PHASE3Maridebart cafraglutide
Novo Nordisk A/S Sponsored ADR Class BNVO18PHASE3Semaglutide
Pfizer Inc.PFE1PHASE3PF-08653944
ProKidney Corp. Class APROK1PHASE3Renal Autologous Cell Therapy
Oramed Pharmaceuticals IncorporatedORMP1PHASE3ORMD-0801
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib, ezetimibe daily
AstraZeneca PLCAZN3PHASE2AZD6234
Alnylam Pharmaceuticals, IncALNY2PHASE2ALN-4324
MediciNova, Inc.MNOV1PHASE2MN-001
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-ALK7
MannKind CorporationMNKD1PHASE2Technosphere Insulin
Merck & Co., Inc.MRK1PHASE1MK-1403, additive coformulation
Abbott LaboratoriesABT6N/AUndisclosed
Biomea Fusion IncBMEA2PHASE2icovamenib
Insulet CorporationPODD5 - Undisclosed
Milestone Pharmaceuticals, Inc.MIST2PHASE2CX11
DexCom, Inc.DXCM6 - Undisclosed
Design Therapeutics, Inc.DSGN1PHASE2Farxiga, Onglyza, Metformin Mix Treat type 2 diabetes, China Import
MiMedx Group, Inc.MDXG1N/AUndisclosed
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