Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
NCT00614939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572
Last updated 2011-05-19
Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.
Conditions
Interventions
- DRUG
-
Saxagliptin
2.5 mg once daily oral dose
- DRUG
-
Placebo
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Peter Ohman, MD, PhD · AstraZeneca
-
Deborah Price, MSc · AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-01-31
- Primary Completion
- 2009-06-30
- Completion
- 2010-03-31
Countries
- United States
- Belarus
- Bulgaria
- Croatia
- Czechia
- Estonia
- Germany
- Hungary
- Latvia
- Lithuania
- Poland
- Romania
- Russia
- Ukraine
Study Locations
More Related Trials
-
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
NCT00666458 ·Status: COMPLETED ·Phase: PHASE3
-
Saxagliptin Triple Oral Therapy
NCT01128153 ·Status: COMPLETED ·Phase: PHASE3
-
Risk of Cardiovascular Events in Patients With Type 2 Diabetes Initiating Oral Antidiabetic Treatments
NCT01086280 ·Status: COMPLETED
-
Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
NCT01619059 ·Status: COMPLETED ·Phase: PHASE3
-
Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
NCT01006603 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
NCT00313313 ·Status: COMPLETED ·Phase: PHASE3
-
Risk of Acute Liver Failure Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
NCT01086293 ·Status: COMPLETED
-
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
NCT01107886 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Saxagliptin on Endothelial Function
NCT01319357 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin
NCT00757588 ·Status: COMPLETED ·Phase: PHASE3
-
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
NCT00575588 ·Status: COMPLETED ·Phase: PHASE3
-
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
NCT01608724 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects
NCT00935467 ·Status: COMPLETED ·Phase: PHASE1
-
Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
NCT00770302 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
NCT00683657 ·Status: COMPLETED ·Phase: PHASE3
-
An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
NCT00960076 ·Status: COMPLETED ·Phase: PHASE3
-
Risk of Hospitalization for Severe Hypersensitivity (Including Severe Skin Reactions) in Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
NCT01086319 ·Status: COMPLETED
-
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
NCT02284893 ·Status: COMPLETED ·Phase: PHASE3
-
A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
NCT02681094 ·Status: COMPLETED ·Phase: PHASE3
-
Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure
NCT02917031 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Multiple Doses of Saxagliptin (BMS-477118)
NCT00950599 ·Status: COMPLETED ·Phase: PHASE2
-
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
NCT02551874 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus
NCT00885378 ·Status: COMPLETED ·Phase: PHASE3
-
Saxagliptin in Combination With Dapagliflozin - Effects on Islet Cell Function
NCT02304081 ·Status: COMPLETED ·Phase: PHASE4
-
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
NCT01162876 ·Status: COMPLETED ·Phase: PHASE3