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| Sponsor: | ActivX Biosciences, Inc. |
|---|---|
| Collaborator: |
Kyorin Pharmaceutical Co.,Ltd |
| Information provided by: | ActivX Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT00995345 |
Purpose
The purpose of this study is to assess the safety and effectiveness of KRP-104 on diabetes in patients with type 2 diabetes inadequately controlled on metformin alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: KRP-104 Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Asses the Safety and Efficacy of Once-Daily KRP-104 in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Alone. |
| Enrollment: | 403 |
| Study Start Date: | October 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dose 1: KRP-104
Tablet
|
Drug: KRP-104
Tablet
|
|
Experimental: Dose 2: KRP-104
Tablet
|
Drug: KRP-104
Tablet
|
|
Experimental: Dose 3: KRP-104
Tablet
|
Drug: KRP-104
Tablet
|
|
Experimental: Dose 4: KRP-104
Tablet
|
Drug: KRP-104
Tablet
|
|
Placebo Comparator: Placebo
Tablet
|
Drug: Placebo
Tablet
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients meeting the following criteria at the screening visit (Visit 1) will be eligible to participate in the trial:
On a stable dose (Greater than or equal to 10 weeks at the same dose) of metformin monotherapy (Less than or equal to 1500 mg/day or maximum tolerated dose), have an HbA1c greater than or equal to 7.0% and less than or equal to 10.5%; or
Exclusion Criteria:
Presence of any of the following conditions:
Contacts and Locations
Show 46 Study Locations
More Information
| Responsible Party: | Diane Plotkin, PhD/ Senior Director, Clinical Development, ActivX Biosciences, Inc../Kyorin Pharmacetuical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00995345 History of Changes |
| Other Study ID Numbers: | 0104-005 |
| Study First Received: | October 12, 2009 |
| Last Updated: | February 4, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; Argentina: Human Research Bioethics Committee; Argentina: Ministry of Health; Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control; Poland: Ethics Committee; Poland: Ministry of Health; Russia: Ethics Committee; Russia: Ministry of Health and Social Development of the; South Africa: Medicines Control Council; South Africa: Human Research Ethics Committee |
|
Type 2 Diabetes Metformin |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |