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taspoglutide

Phase 3

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials10
Total Enrollment5,467

FDA Designations

No designations recorded

Clinical trial landscape

taspoglutide · 10 trials · 1 indication

Phase 3 7Phase 2 2Phase 1 1
NCT01018173A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular DiseaseDiabetes Mellitus Type 2
COMPLETED2,118 Analytics
NCT00909597A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 DiabetesDiabetes Mellitus Type 2
COMPLETED756 Analytics
NCT00823992A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin MonotherapyDiabetes Mellitus Type 2
COMPLETED305 Analytics
NCT00809705A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 DiabetesDiabetes Mellitus Type 2
COMPLETED60 Analytics
NCT00755287A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.Diabetes Mellitus Type 2
COMPLETED1,072 Analytics
NCT00744367A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.Diabetes Mellitus Type 2
COMPLETED326 Analytics
NCT00744926A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.Diabetes Mellitus Type 2
COMPLETED373 Analytics
PHASE3COMPLETED
A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
Diabetes Mellitus Type 2Unlock trial analytics
PHASE3COMPLETED
A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes
Diabetes Mellitus Type 2Unlock trial analytics
PHASE3COMPLETED
A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
Diabetes Mellitus Type 2Unlock trial analytics
PHASE3COMPLETED
A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes
Diabetes Mellitus Type 2Unlock trial analytics
PHASE3COMPLETED
A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
Diabetes Mellitus Type 2Unlock trial analytics
PHASE3COMPLETED
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
Diabetes Mellitus Type 2Unlock trial analytics
PHASE3COMPLETED
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Time to cardiovascular composite primary endpoints
event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Absolute change from baseline in HbA1c
24 weeks
Tmax, log (AUC), log(Cmax)of paracetamol
Days -1, 1, 5, 29, 33, 78 and 82
Percentage of patients withdrawn because of gastrointestinal effects
Week 9
Absolute change from baseline in HbAlc
Week 8
Incremental area under insulin concentration time curve relative to basal insulin concentration
First 10 minutes after glucose bolus

Secondary Endpoints

Secondary cardiovascular composite endpoints
event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Individual components of primary cardiovascular composite endpoints
event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Total mortality
assessed at end of study, week 104
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
placeboPLACEBO_COMPARATOR -
taspoglutideEXPERIMENTAL -
pioglitazoneACTIVE_COMPARATOR -
taspoglutide 10mgEXPERIMENTALtaspoglutide 10mg sc weekly
taspoglutide 10mg/20mgEXPERIMENTALtaspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
insulin glargineACTIVE_COMPARATORinsulin glargine starting dose 10 IU daily in addition to continued prestudy metformin treatment
taspoglutide 10 mgEXPERIMENTALtaspoglutide 10 mg once weekly in addition to continued prestudy metformin treatment
taspoglutide 10 mg/20 mgEXPERIMENTALtaspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued prestudy metformin treatment
taspoglutide 10mg scEXPERIMENTAL -
taspoglutide 10mg/20mg scEXPERIMENTAL -
Taspoglutide 20mgEXPERIMENTALsc weekly
Taspoglutide 20mg-30mgEXPERIMENTALsc weekly
Taspoglutide 20mg-40mgEXPERIMENTALsc weekly
4EXPERIMENTAL -
5EXPERIMENTAL -
6PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
placeboDRUGsc weekly
taspoglutideDRUG10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly
pioglitazoneDRUG30mg po once daily for 4 weeks, followed by 45mg once daily
insulin glargineDRUGstarting dose 10 IU daily
metforminDRUGAs prescribed
Taspoglutide 20mgDRUGsc weekly
Taspoglutide 20mg-30mgDRUGsc weekly
Taspoglutide 20mg-40mgDRUGsc weekly
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites288

Inclusion Criteria: * adult patients, \>18 years of age * diabetes mellitus type 2 * HbA1c \>/=6.5% and \</=10% at screening * BMI \>/=23kg/m2 * cardiovascular disease with onset \>/=1 month prior to screening Exclusion Criteria: * diagnosis or history of type 1 diabetes or secondary forms of dia...

Countries:United StatesAustraliaBrazilBulgariaCanadaCzechiaDenmarkEstoniaGermanyHungaryIndiaIsraelLithuaniaMalaysiaMexicoPolandRomaniaRussiaSlovakiaSouth AfricaSpainTaiwanThailandUkraineUnited KingdomCosta RicaFranceNew ZealandPeruPuerto RicoItalyNorth MacedoniaAustriaBelgiumFinlandGreeceGuatemalaHong KongPortugalSerbiaSouth KoreaLatvia
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Frequently asked questions about taspoglutide

What is taspoglutide used for?

Taspoglutide is an investigational drug being developed for the treatment of Type 2 Diabetes Mellitus. It is a small molecule that has been studied in clinical trials for its effects on glycemic control in patients with this condition.

Who makes taspoglutide?

Taspoglutide is being developed by Roche Holding AG, a company publicly traded under the ticker symbol RHHBY. The drug has been studied in clinical trials sponsored by the company.

What phase is taspoglutide in?

Taspoglutide has reached Phase 3 clinical development. However, all clinical trials for the drug are completed, with no active trials currently ongoing. It remains an investigational agent and has not been approved by regulatory authorities.

What clinical trials is taspoglutide in?

Taspoglutide has been studied in multiple clinical trials, including NCT00423501, NCT00460941, NCT00809705, and NCT00811460. These trials have investigated its use in Type 2 Diabetes Mellitus, with a total enrollment of 5467 participants across all studies.

Is taspoglutide the same as a GLP-1 analogue?

Taspoglutide is described as a GLP-1 analogue in clinical trial titles. It has been studied for its effects on gastric emptying and glycemic control in patients with Type 2 Diabetes Mellitus, consistent with the mechanism of GLP-1 receptor agonists.