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DPP- Inhibitor

Phase 2

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

DPP- Inhibitor target and mechanism

ModalitySmall molecule

Also known as DPP-IV Inhibitor

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment509

FDA Designations

No designations recorded

DPP- Inhibitor clinical trials

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 being studied for the treatment of Diabetes Mellitus Type 2, a metabolic condition. It is an investigational small molecule developed by Roche Holding AG. The clinical program has focused on adults with type 2 diabetes, with two completed Phase 2 trials enrolling a combined 509 participants.

Who is developing DPP- Inhibitor?

DPP- Inhibitor is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 2 clinical program evaluating the compound in patients with Diabetes Mellitus Type 2. The program includes two completed trials conducted across sites in the United States, Europe, Latin America, and Australia.

What phase is DPP- Inhibitor in?

DPP- Inhibitor is in Phase 2 clinical development. Both of its Phase 2 trials in Diabetes Mellitus Type 2 have been completed, and no trials are currently listed as active. The studies together enrolled 509 participants. It is an investigational agent and has not been approved for any indication.

What clinical trials is DPP- Inhibitor in?

Two completed Phase 2 trials have evaluated DPP- Inhibitor in Diabetes Mellitus Type 2. NCT00111670 enrolled 291 patients across the United States, Bulgaria, Costa Rica, Estonia, Latvia, Lithuania, Mexico, Puerto Rico, and Romania. NCT00111631 enrolled 218 patients across the United States, Australia, Canada, Germany, Italy, and Puerto Rico. Both were randomized, double-blind, and placebo-controlled.

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

Yes, DPP- Inhibitor and DPP-IV Inhibitor refer to the same agent. DPP-IV Inhibitor is an alternative name used for this Roche Holding AG compound in its Phase 2 program for Diabetes Mellitus Type 2. Searches using either name point to the same investigational small molecule and the same two completed clinical trials.

How were the DPP- Inhibitor Phase 2 trials designed?

Both DPP- Inhibitor Phase 2 trials in Diabetes Mellitus Type 2 were randomized, double-blind, and placebo-controlled. NCT00111670 enrolled 291 participants and NCT00111631 enrolled 218, for a total of 509. Eligible patients were 18 years or older, and both sexes were included. Neither trial selected patients by biomarker.