Trial information
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Status: Completed
Protocol number: BM18102
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
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.
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 Inhibitor
Primary outcome: 1. Absolute change from baseline in HbAlc
Time frame: Week 12
Key secondary outcomes: 1. Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate Time frame: Week 12
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 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.
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: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
Costa Rica
Estonia
Latvia
Lithuania
Mexico
- Chihuahua
- Guadalajara
- Mexico City
- Monterrey
- Pachuca
Romania
- Bucharest
- Cluj-Napoca
- Ploiesti
- Tirgu-Mures
United States
- Clearwater, FL
- Hialeah, FL
- Blue Ridge, GA
- Aurora, IL
- Oxon Hill, MD
- Troy, MI
- Pahrump, NV
- Portland, OR
- Warminster, PA
- Ponce, PR
- Dallas, TX
- San Antonio, TX
- Richmond, VA
