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: July 7, 2014
Last verified: July 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Glucose AUC [ Time Frame: Days -1, 1 and 8. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517465

Locations
Germany
Berlin, Germany, 14050
Neuss, Germany, 41460
Hungary
Balatonfuered, Hungary, 8230
Budapest, Hungary, 1027
Slovakia
Bratislava, Slovakia, 833 05
Bratislava, Slovakia, 82108
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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517465     History of Changes
Other Study ID Numbers: NP20945
Study First Received: August 16, 2007
Last Updated: July 7, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 20, 2014