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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517465
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

August 16, 2007
August 17, 2007
November 2, 2016
September 2007
March 2009   (Final data collection date for primary outcome measure)
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]
  • Glucose AUC [ Time Frame: Days -1, 1 and 8. ]
Safety: AEs, laboratory parameters, vital signs. Pharmacodynamics: Glucose AUC on days -1, 1 and 8.
Complete list of historical versions of study NCT00517465 on Archive Site
  • Insulin, C-peptide, glucagon and GLP-1 AUC [ Time Frame: Days -1, 1 and 8 ]
  • 24h glucose [ Time Frame: Days -1, 1 and 8 ]
  • Lipid profiles [ Time Frame: Days -1 and 8 ]
  • Pharmacokinetic parameters [ Time Frame: Days 1 and 8 ]
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.
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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 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.
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Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary,   Slovakia,   United Kingdom
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Hoffmann-La Roche
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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