A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.

Diabetes Mellitus Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517465
• Other study ID #: NP20945
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2007
• Last updated: November 1, 2016
• Start date: September 2007
• Est. completion date: March 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
po bid
• RG1511
Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Germany,  Hungary,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, laboratory parameters, vital signs.		Throughout study	No
Primary	Glucose AUC		Days -1, 1 and 8.	No
Secondary	Insulin, C-peptide, glucagon and GLP-1 AUC		Days -1, 1 and 8	No
Secondary	24h glucose		Days -1, 1 and 8	No
Secondary	Lipid profiles		Days -1 and 8	No
Secondary	Pharmacokinetic parameters		Days 1 and 8	No