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DPP- Inhibitor

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment509

FDA Designations

No designations recorded

Clinical trial landscape

DPP- Inhibitor · 2 trials · 1 indication

Phase 2 2
NCT00111670A Study of DPP-IV Inhibitor in Patients With Type 2 DiabetesDiabetes Mellitus Type 2
COMPLETED291 Analytics
NCT00111631A Study of DPP-IV Inhibitor in Patients With Type 2 DiabetesDiabetes Mellitus Type 2
COMPLETED218 Analytics
PHASE2COMPLETED
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Diabetes Mellitus Type 2Unlock trial analytics
PHASE2COMPLETED
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Diabetes Mellitus Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change from baseline in HbAlc\n\n
Week 12
Absolute change from baseline in HbAlc\n
Week 16

Secondary Endpoints

Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate
Week 12
AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n
Throughout study
Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n
Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DPP-IV InhibitorDRUGEscalating doses po bid or qd
PlaceboDRUGpo bid or qd
MetforminDRUGAs prescribed
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * adult patients 18-75 years of age; * type 2 diabetes diagnosed \>=1 month before screening; * no previous treatment, or previous treatment with no more than 2 oral medications. Exclusion Criteria: * type 1 diabetes; * type 2 diabetes treated with insulin or a PPAR gamma agon...

Countries:United StatesBulgariaCosta RicaEstoniaLatviaLithuaniaMexicoPuerto RicoRomaniaAustraliaCanadaGermanyItaly
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Frequently asked questions about DPP- Inhibitor

What is DPP- Inhibitor used for?

DPP- Inhibitor is an investigational small molecule being developed for the treatment of Diabetes Mellitus Type 2. It is currently in Phase 2 clinical development and has been studied in completed trials involving patients with Type 2 diabetes.

Who makes DPP- Inhibitor?

DPP- Inhibitor is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 diabetes.

What phase is DPP- Inhibitor in?

DPP- Inhibitor is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, with a total of 509 participants enrolled.

What clinical trials is DPP- Inhibitor in?

DPP- Inhibitor has been studied in two completed Phase 2 trials: NCT00111631, which enrolled 218 patients, and NCT00111670, which enrolled 291 patients. Both trials were randomized, double-blind, placebo-controlled studies in patients with Type 2 diabetes.

Is DPP- Inhibitor the same as DPP-IV Inhibitor?

DPP- Inhibitor is also referred to as DPP-IV Inhibitor in clinical trial records. The trials listed under NCT00111631 and NCT00111670 describe the drug as a DPP-IV Inhibitor, indicating that these names refer to the same investigational compound.