Trial information
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Status: Completed
Protocol number: BM18106
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of the DPP-IV inhibitor on HbA1c and safety in patients with type 2 diabetes treated with a stable dose of metformin
Brief summary: 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.
Target sample size is
200.
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 Inhibitor
Primary outcome: 1. Absolute change from baseline in HbAlc
Time frame: Week 16
Key secondary outcomes: 1. Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate
Time frame: Week 16
2. AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG
Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Canada
- Winnipeg, MB
- Halifax, NS
- London, ON
- Toronto, ON
Germany
- Bad Lauterberg
- Berlin
- Dresden
- Görlitz
- Mainz
- Neuss
Italy
United States
- Concord, CA
- Boulder, CO
- Newark, DE
- Clearwater, FL
- Miami, FL
- Chicago, IL
- Detroit, MI
- Rochester, NY
- Durham, NC
- Mogadore, OH
- Portland, OR
- Warminster, PA
- Ponce, PR
- Dallas, TX
- Midland, TX
- San Antonio, TX
