Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00111670 |
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: DPP-IV Inhibitor Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes |
Enrollment: | 291 |
Study Completion Date: | July 2006 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: DPP-IV Inhibitor
Escalating doses po bid or qd
|
2: Experimental |
Drug: DPP-IV Inhibitor
Escalating doses po bid or qd
|
3: Experimental |
Drug: DPP-IV Inhibitor
Escalating doses po bid or qd
|
4: Experimental |
Drug: DPP-IV Inhibitor
Escalating doses po bid or qd
|
5: Placebo Comparator |
Drug: Placebo
po bid or qd
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BM18102 |
Study First Received: | May 24, 2005 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00111670 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |