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GK Activator

Phase 2

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

GK Activator target and mechanism

ModalitySmall molecule

Also known as GK Activator (2)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials7
Total Enrollment929

FDA Designations

No designations recorded

GK Activator clinical trials

GK Activator · 7 trials · 1 indication

Phase 2 4Phase 1 3
NCT00366379A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.Diabetes Mellitus Type 2
COMPLETED127 Analytics
NCT00316758A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.Diabetes Mellitus Type 2
COMPLETED259 Analytics
NCT00266240A Study of GK Activator (2) in Patients With Type 2 Diabetes MellitusDiabetes Mellitus Type 2
COMPLETED267 Analytics
NCT00266253A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of MetforminDiabetes Mellitus Type 2
COMPLETED220 Analytics
PHASE2COMPLETED
A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.
Diabetes Mellitus Type 2Unlock trial analytics
PHASE2COMPLETED
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
Diabetes Mellitus Type 2Unlock trial analytics
PHASE2COMPLETED
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus Type 2Unlock trial analytics
PHASE2COMPLETED
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of patients at each dose who achieve FPG <100mg/dL.
Throughout study
AEs, laboratory parameters, ECG.
Throughout study
HbA1c mean change from baseline, compared to placebo.
Week 12
HbA1c mean change from baseline compared with placebo.
Week 12
AUC0-6h of plasma glucose
Days -1, 6 and 12
AUC0-12h of GK Activator (2) and metabolite.
Days 6 and 12
AUC0-tau of glyburide
Days -1 and 6
AUC0-inf of GK Activator (2) and simvastatin acid.
Days 1, 8 and 15
AUC0-6h of plasma glucose from pre-dose to 6h post-dose.
Days 1, 8 and 15
Vital signs, adverse events, laboratory parameters.
Throughout study

Secondary Endpoints

Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.
At intervals throughout study
AEs, laboratory parameters.
Throughout study
Mean change from original baseline in HbA1c, FPG, lipid profile.
Throughout study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5EXPERIMENTAL -
6ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
GK Activator (2)DRUG25-200mg po bid for 20 weeks
MetforminDRUGAs prescribed, in patients who were in study BM18249
PlaceboDRUGpo bid
GlyburideDRUG10-20mg po daily
SimvastatinDRUG80mg po
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * adult patients, 18-75 years of age; * type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening. Exclusion Criteria: * type 1 diabetes mellitus; * treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 m...

Countries:United StatesEstoniaLatviaMexicoAustraliaBulgariaCanadaCroatiaGermanyGuatemalaHungaryPolandSpainUnited KingdomSlovakia
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Frequently asked questions about GK Activator

What is GK Activator (2) used for?

GK Activator (2) is an investigational small molecule being studied for the treatment of type 2 diabetes mellitus. It is a metabolic therapy developed by Roche Holding AG. It has been evaluated in clinical trials in adults with type 2 diabetes, including drug-drug interaction studies and a dose-titration study.

Who makes GK Activator (2)?

GK Activator (2) is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program for this investigational type 2 diabetes therapy.

What phase is GK Activator (2) in?

GK Activator (2) has reached Phase 2 in clinical development. A Phase 2 dose-titration study in patients with type 2 diabetes has been completed. The program also includes completed Phase 1 studies. It is an investigational drug and has not been approved by the FDA.

What clinical trials is GK Activator (2) in?

GK Activator (2) has been studied in seven completed clinical trials, including NCT00366379, a Phase 2 dose-titration study in type 2 diabetes, and Phase 1 drug-drug interaction studies NCT00388986 with glyburide and NCT00377442 with simvastatin. NCT00368368 evaluated the effect of renal impairment. No trials are currently active.

Is GK Activator the same as GK Activator (2)?

Yes, GK Activator (2) is also known as GK Activator. The two names refer to the same investigational small molecule developed by Roche Holding AG for type 2 diabetes mellitus.