A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

Hoffmann-La Roche218 enrolled

Overview

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

218

Conditions

Diabetes Mellitus Type 2

Interventions

DPP-IV InhibitorDRUG

Escalating doses po bid

MetforminDRUG

As prescribed

PlaceboDRUG

po bid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients 18-75 years of age; * type 2 diabetes; * stable metformin therapy for \>=3 months before screening. Exclusion Criteria: * women who are pregnant, breast-feeding, or not using an adequate contraceptive method; * type 1 diabetes; * any anti-hyperglycemic medication other than metformin in the last 3 months.

Locations (37)

Unnamed facility

Outcomes

Primary Outcomes

Absolute change from baseline in HbAlc\n

Time frame: Week 16

Secondary Outcomes

Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n

Time frame: Week 16

AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n

Time frame: Throughout study

Data from ClinicalTrials.gov

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