Diabetes Mellitus Type 2 Clinical Trial
Official title:
A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.
This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| 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 | |
| Completed |
NCT00517465 -
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
|
Phase 1 | |
| 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 |