A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes

Hoffmann-La Roche0 sites291 target enrollmentJune 2005

ConditionsDiabetes Mellitus Type 2

InterventionsDPP-IV Inhibitor Placebo

DrugsDPP-IV Inhibitor Placebo

Overview

Phase: Phase 2
Intervention: DPP-IV Inhibitor
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 291
Primary Endpoint: Absolute change from baseline in HbAlc\n\n
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

July 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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 agonist during the 3 months before screening;
•patients who are pregnant, breastfeeding or not using a reliable contraceptive method.

Arms & Interventions

1

Intervention: DPP-IV Inhibitor

2

Intervention: DPP-IV Inhibitor

3

Intervention: DPP-IV Inhibitor

4

Intervention: DPP-IV Inhibitor

5

Intervention: Placebo

Outcomes

Primary Outcomes

Absolute change from baseline in HbAlc\n\n

Time Frame: Week 12

Secondary Outcomes

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)