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NCT ID: NCT01011868 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

NCT ID: NCT01010061 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)

Start date: December 21, 2009
Phase: Phase 3
Study type: Interventional

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

NCT ID: NCT01009762 Completed - HIV INFECTIONS Clinical Trials

Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection

HIV-VAC
Start date: September 2009
Phase: Phase 1
Study type: Interventional

Treatment: Immunization with a peptide-mix of 17 Clusters of Differentiation number 8 (CD8) T cell minimal epitopes and 3 Clusters of Differentiation number 4 (CD4) T cell epitopes and a new adjuvant (CAF01). The vaccine should induce cellular immunity against human immuno-deficiency virus type-1 (HIV-1). Target group: Untreated healthy individuals with chronic HIV-1 infection who are not in antiretroviral treatment. Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine. The secondary purpose is to evaluate the clinical effect of the vaccination treatment as measured by induction of new T cell immunity, lowering of HIV-1 ribonucleic acid (RNA) viral load in plasma, and improvement in the patient CD4 lymphocyte blood counts. Design: The experiment is designed as a single-blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in Denmark. Numbers of individuals: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls). The hypothesis is that a redirection of cytotoxic T lymphocyte (CTL) immunity to selected relatively immune silent (subdominant) but conserved CTL targets on multiple sites in HIV-1 could provide a better immune control of the virus replication. This could result in lowering of viral load thereby prolonging the time to antiretroviral therapy.

NCT ID: NCT01009580 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes

BOOSTâ„¢
Start date: November 5, 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.

NCT ID: NCT01009528 Completed - Type 2 Diabetes Clinical Trials

Electronic Feedback on Diabetic Care to General Practitioners

Start date: March 2007
Phase: N/A
Study type: Interventional

The aim of this study is to determine whether electronic feedback to general practitioners on quality of Type 2-Diabetes care increases the quality of care measured on process and outcome measures contained in the national guidelines. Effect evaluation will be performed using a mixed method design.

NCT ID: NCT01007669 Completed - Clinical trials for Musculoskeletal Diseases

Effects of Specified Work Site Physical Activity Intervention Among Employees With Physical Heavy Work

Start date: August 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of specified worksite physical-activity interventions on musculoskeletal disorders in an industry with physical heavy workload.

NCT ID: NCT01007435 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

Start date: October 2009
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

NCT ID: NCT01007331 Completed - Atopic Dermatitis Clinical Trials

Probiotic Bacteria to Infants With Atopic Dermatitis

Start date: November 2006
Phase: N/A
Study type: Interventional

The objective of the study is to examine whether 8 weeks intervention with probiotics influence the eczema in infants suffering from Atopic Dermatitis. Furthermore the influence of the immunologic status and the intestinal microflora, inflammation and permeability will be investigated.

NCT ID: NCT01006941 Completed - Clinical trials for Relapsing Multiple Sclerosis

Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

TRIMS A
Start date: May 2010
Phase: Phase 2
Study type: Interventional

The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.

NCT ID: NCT01006603 Completed - Clinical trials for Type 2 Diabetes Mellitus

Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin

GENERATION
Start date: October 2009
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.