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Exenatide LAR

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Feb 24, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Exenatide LAR · 1 trial · 1 indication

Phase 2 1
NCT00103935Study Examining Exenatide Long-Acting Release in Subjects With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED45 Analytics
PHASE2COMPLETED
Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM)
Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours

Secondary Endpoints

Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus
Various time intervals from Day 1 to Week 15
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27).
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group A1PLACEBO_COMPARATORPlacebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR
Group A2PLACEBO_COMPARATORPlacebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR
Group BEXPERIMENTALExenatide lead-in followed by exenatide LAR 0.8 mg weekly
Group CEXPERIMENTALExenatide lead-in followed by exenatide LAR 2.0 mg weekly

Interventions

NameTypeDescription
placeboDRUGSubcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
Exenatide LARDRUGSubcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Has type 2 diabetes treated with either: \*A stable regimen of metformin for a minimum of 3 months, and/or \*Diet modification and exercise for a minimum of 3 months. * Has HbA1c of 7.1% to 11.0%, inclusive. * Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive. Ex...

Countries:United States
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Frequently asked questions about Exenatide LAR

What is Exenatide LAR used for?

Exenatide LAR is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is a long-acting release formulation of exenatide, designed to provide sustained glucose control. As of the available data, it is in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Exenatide LAR?

Exenatide LAR is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Type 2 Diabetes Mellitus.

What phase is Exenatide LAR in?

Exenatide LAR is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 2 trial has been completed, and the drug is being studied for its potential use in treating Type 2 Diabetes Mellitus.

What clinical trials is Exenatide LAR in?

Exenatide LAR has one completed clinical trial registered under NCT00103935, titled 'Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes'. This Phase 2, randomized, double-blind, placebo-controlled study enrolled 45 participants in the United States. The trial has been completed, and no active trials are currently listed.

Is Exenatide LAR FDA approved?

Exenatide LAR is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The completed Phase 2 trial (NCT00103935) evaluated its safety and efficacy, but the drug has not yet received regulatory approval from the FDA or any other health authority.