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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517465
First Posted: August 17, 2007
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RG1511 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]
  • Glucose AUC [ Time Frame: Days -1, 1 and 8. ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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: 2 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: 3 Drug: RG1511
Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
Placebo Comparator: 4 Drug: Placebo
po bid

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517465


Locations
Germany
Berlin, Germany, 14050
Neuss, Germany, 41460
Hungary
Balatonfuered, Hungary, 8230
Budapest, Hungary, 1027
Slovakia
Bratislava, Slovakia, 82108
Bratislava, Slovakia, 833 05
United Kingdom
Slough, United Kingdom, SL1 4AA
Welwyn Garden City, United Kingdom, AL7 1TW
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517465     History of Changes
Other Study ID Numbers: NP20945
First Submitted: August 16, 2007
First Posted: August 17, 2007
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases