Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT00517465

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 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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00517465
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 1
Start date September 2007
Completion date March 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT01267448 - Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia Phase 4
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Terminated NCT02743598 - Liraglutide for HIV-associated Neurocognitive Disorder Phase 4
Terminated NCT02373865 - Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes Phase 4
Completed NCT01741181 - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2 Phase 4
Completed NCT01305434 - Mulberry Leaf Extract and Blood Glucose Control in Diabetics Phase 1/Phase 2
Completed NCT01330121 - Bridging the Gap by Transitional Care N/A
Recruiting NCT00992797 - Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity Phase 2
Completed NCT01580904 - Impact of Pharmaceutical Care in Diabetics Patients N/A
Active, not recruiting NCT00728403 - Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes Phase 2
Completed NCT00763815 - GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone Phase 3
Active, not recruiting NCT00529815 - Continuous Glucose Monitoring in Patients With Type 2 Diabetes Phase 4
Withdrawn NCT00417716 - Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema Phase 3
Completed NCT00119041 - Diabetes Telemedicine Consultation: A Systems Improvement Intervention N/A
Withdrawn NCT00600236 - HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population Phase 3
Active, not recruiting NCT05887635 - Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus N/A
Completed NCT03903965 - Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.
Completed NCT02666924 - Cooking Classes for Chinese Canadian Patients Living With Diabetes N/A
Recruiting NCT02501850 - The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a) Phase 4
Completed NCT01964833 - PDT and Periodontal Treatment in DMT2 Patients N/A