Trial information
A Study of DPP-IV (3) in Patients With Type 2 Diabetes.
Status: Completed
Protocol number: BC20779
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind dose-ranging study of the effect of DPP-IV (3) on HbA1c, other efficacy parameters, pharmacokinetics and safety in patients with type 2 diabetes (BC20779)
Brief summary: 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. Target sample size is
250.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: DPP-IV (3)
Primary outcome: 1. Absolute change in HbAlc Time frame: Week 12
Key secondary outcomes: 1. Absolute change in FPG, HbAlc response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile. Time frame: Week 12
2. AEs, vital signs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes diagnosed >= 1 month before screening;
- drug-naive, or pretreated with 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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 07/19/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Canberra
- St. Leonards
Brazil
China
Guatemala
Mexico
- Aguascalientes
- Chihuahua
- Guadalajara
- Mexico City
- Pachuca
- Tampico
Russian Federation
- Moscow
- Saratov
- St Petersburg
- Yaroslavl
Spain
- Alzira
- Bacarot Alicant
- Barcelona
United Kingdom
- Bath
- Frome
- Glasgow
- Lanarkshire
- Liverpool
United States
- Hot Springs, AR
- Concord, CA
- Los Angeles, CA
- Chicago, IL
- Avon, IN
- Indianapolis , IN
- Oxon Hill, MD
- Troy, MI
- Omaha, NE
- Charlotte, NC
- Beaver, PA
