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 · Type: INTERVENTIONAL · Enrollment: 93
Last updated 2015-06-01
Summary
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
Conditions
Interventions
- DRUG
-
Saxagliptin
Tablets, Oral, 5mg, once daily, 4 weeks
- DRUG
-
Tablets, Oral, 0 mg, once daily, 4 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 77 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2009-02-28
- Completion
- 2009-02-28
Countries
- United States
- Argentina
- Israel
- Italy
- Mexico
- Philippines
- Puerto Rico
- Sweden
Study Locations
More Related Trials
-
Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
NCT00698932 ·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
-
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
NCT00666458 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
NCT00374907 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes
NCT01006590 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
NCT02104804 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
NCT02273050 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
NCT00313313 ·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
-
Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control
NCT00918879 ·Status: COMPLETED ·Phase: PHASE3
-
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
NCT01107886 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects
NCT00935467 ·Status: COMPLETED ·Phase: PHASE1
-
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
NCT01434186 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
NCT01619059 ·Status: COMPLETED ·Phase: PHASE3
-
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)
NCT00885352 ·Status: COMPLETED ·Phase: PHASE3
-
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
NCT00337610 ·Status: COMPLETED ·Phase: PHASE3
-
Saxagliptin Triple Oral Therapy
NCT01128153 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
NCT00813995 ·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
-
Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)
NCT00350779 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
NCT01076075 ·Status: COMPLETED ·Phase: PHASE3
-
A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
NCT02419612 ·Status: COMPLETED ·Phase: PHASE3