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

Hoffmann-La Roche291 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

291

Conditions

Diabetes Mellitus Type 2

Interventions

DPP-IV InhibitorDRUG

Escalating doses po bid or qd

PlaceboDRUG

po bid or qd

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 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.

Locations (40)

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

Time frame: Week 12

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

Time frame: Throughout study

Data from ClinicalTrials.gov

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