Trial information
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
Status: Recruiting
Protocol number: NP20945
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A multi-center, double-blind, randomized, placebo-controlled, parallel-group, multiple-ascending-dose study to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of R1511 in type 2 diabetic (T2D) patients
Brief summary: This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 40.
Study phase: I
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: R1511
Primary outcome: 1. AEs, laboratory parameters, vital signs. Time frame: Throughout study
2. Glucose AUC Time frame: Days -1, 1 and 8.
Key secondary outcomes: 1. Insulin, C-peptide, glucagon and GLP-1 AUC Time frame: Days -1, 1 and 8
2. 24h glucose Time frame: Days -1, 1 and 8
3. Lipid profiles Time frame: Days -1 and 8
4. Pharmacokinetic parameters Time frame: Days 1 and 8
Inclusion criteria:
- adult patients, 18-65 years of age;
- type 2 diabetic patients;
- naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment.
Exclusion criteria:
- type 1 diabetes mellitus;
- clinically significant cardiovascular disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: September, 2007
Trial registration date: 08/15/2007
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
Hungary
Poland
Slovakia
United Kingdom
