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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517465
First received: August 16, 2007
Last updated: November 3, 2014
Last verified: November 2014

August 16, 2007
November 3, 2014
September 2007
March 2009   (final data collection date for primary outcome measure)
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Glucose AUC [ Time Frame: Days -1, 1 and 8. ] [ Designated as safety issue: No ]
Safety: AEs, laboratory parameters, vital signs. Pharmacodynamics: Glucose AUC on days -1, 1 and 8.
Complete list of historical versions of study NCT00517465 on ClinicalTrials.gov Archive Site
  • Insulin, C-peptide, glucagon and GLP-1 AUC [ Time Frame: Days -1, 1 and 8 ] [ Designated as safety issue: No ]
  • 24h glucose [ Time Frame: Days -1, 1 and 8 ] [ Designated as safety issue: No ]
  • Lipid profiles [ Time Frame: Days -1 and 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: Days 1 and 8 ] [ Designated as safety issue: No ]
PD: Insulin, C-peptide, glucagon & GLP-1 AUC on days -1, 1 & 8; 24h glucose on day -1, 1 & 8 (qd on days 1 and 8, bid on days 3-7); fasting plasma glucose on days -1 to 11; lipid profiles on day -1 & 8. PK: Plasma & urine parameters on days 1 & 8.
Not Provided
Not Provided
 
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
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

This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety an d tolerability of multiple ascending doses of R1511 compared to placebo in patie nts with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po b id 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 asse ssment 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    po bid
  • Drug: RG1511
    Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
  • Experimental: 1
    Intervention: Drug: RG1511
  • Experimental: 2
    Intervention: Drug: RG1511
  • Experimental: 3
    Intervention: Drug: RG1511
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary,   Slovakia,   United Kingdom
 
NCT00517465
NP20945
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP