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Albiglutide or exenatide

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Dec 16, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment361

FDA Designations

No designations recorded

Clinical trial landscape

Albiglutide or exenatide · 1 trial · 1 indication

Phase 2 1
NCT00518115Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin OnlyDiabetes Mellitus, Type 2
COMPLETED361 Analytics
PHASE2COMPLETED
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
Baseline and Week 16

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.

Secondary Endpoints

Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16
Change From Baseline in Waist Circumference at Week 16
Baseline and Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Albiglutide (GSK716155) or exenatideDRUGAlbiglutide weekly subcutaneous injection or exenatide twice daily injection
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites163

Inclusion Criteria: * Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus \[American Diabetes Association, 2004a\] at least three months pre...

Countries:United StatesChileDominican Republic
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Frequently asked questions about Albiglutide or exenatide

What is Albiglutide or exenatide used for?

Albiglutide or exenatide is being studied for the treatment of type 2 diabetes mellitus. It is an investigational therapy in clinical development for this metabolic condition. The drug is being evaluated in patients who are taking no diabetes medication or metformin only.

Who makes Albiglutide or exenatide?

Albiglutide or exenatide is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this drug for type 2 diabetes mellitus.

What phase is Albiglutide or exenatide in?

Albiglutide or exenatide is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed.

What clinical trials is Albiglutide or exenatide in?

Albiglutide or exenatide has one completed Phase 2 clinical trial, registered as NCT00518115. This study was an outpatient trial in patients with type 2 diabetes mellitus who were taking no diabetes medication or metformin only. The trial enrolled 361 participants across the United States, Chile, and the Dominican Republic.

Is Albiglutide or exenatide the same as exenatide?

Albiglutide or exenatide is a drug name that combines two agents, albiglutide and exenatide. The clinical trial NCT00518115 evaluated this combination in patients with type 2 diabetes mellitus. It is distinct from either agent used alone.