A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.

Study Overview
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Brief Summary
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This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
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A Randomized, Double-blind Dose-ranging Study of the Effect of DPP-IV on HbA1c, Other Efficacy Parameters, Pharmacokinetics and Safety in Patients With Type 2 Diabetes (BC20779)

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Placebo
* Drug: RO4876904


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes diagnosed >= 1 month before screening; drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin; BMI 25-45kg/m2. Exclusion Criteria: type 1 diabetes; any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RO4876904 1<br>Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. | Drug: RO4876904<br>* Escalating doses, at a starting dose of 12.5mg po daily.<br>|
| Experimental: RO4876904 2<br>Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. | Drug: RO4876904<br>* Escalating doses, at a starting dose of 12.5mg po daily.<br>|
| Experimental: RO4876904 3<br>Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. | Drug: RO4876904<br>* Escalating doses, at a starting dose of 12.5mg po daily.<br>|
| Experimental: RO4876904 4<br>Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin. | Drug: RO4876904<br>* Escalating doses, at a starting dose of 12.5mg po daily.<br>|
| Placebo Comparator: Placebo<br>Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin. | Drug: Placebo<br>* Placebo po daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in hemoglobin A1c (HbA1c) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile. |  | Week 12 | 
| Adverse events (AEs), vital signs, laboratory parameters. |  | Throughout study |