Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00316082
First received: April 18, 2006
Last updated: November 20, 2009
Last verified: November 2009
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Purpose
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: Saxagliptin Drug: Placebo Drug: metformin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Change From Baseline in Hemoglobin A1 (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
- Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 365 |
| Study Start Date: | June 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
|
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
|
Experimental: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
|
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
|
Experimental: Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
|
Drug: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
|
Experimental: Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
|
Drug: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
|
Placebo Comparator: Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
|
Drug: Placebo
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
|
Detailed Description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication
Eligibility| Ages Eligible for Study: | 18 Years to 77 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes
- Inadequate blood sugar control
Exclusion Criteria:
- Previous treatment for diabetes
- Current treatment with other medications to lower blood sugar
- Major heart, liver or kidney problems
- Women who are pregnant or breastfeeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316082
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| United States, Alabama | |
| Tomac, Inc. | |
| Columbiana, Alabama, United States, 35051 | |
| Winston Technology, Inc. | |
| Haleyville, Alabama, United States, 35565 | |
| United States, Arizona | |
| Clinical Reseacrh Advantage/ Brown Family Medicine | |
| Mesa, Arizona, United States, 85213 | |
| United States, California | |
| Strategos Medical Group | |
| Bakersfield, California, United States, 93311 | |
| Providence Clinical Research | |
| Burbank, California, United States, 91505 | |
| Rx For Life, Inc | |
| Cudahy, California, United States, 90201 | |
| Medical Group Of Encino | |
| Encino, California, United States, 91436 | |
| Southland Clinical Research Center, Inc. | |
| Fountain Valley, California, United States, 92708 | |
| Valley Research | |
| Fresno, California, United States, 93720 | |
| Diabetes Medical Center Of California | |
| Northridge, California, United States, 91325 | |
| In Private Prictice Clinic | |
| Pico Rivera, California, United States, 90660 | |
| San Jose Clinical Research, Inc. | |
| San Jose, California, United States, 95128 | |
| United States, Florida | |
| Central Florida Clinical Trials, Inc. | |
| Altamonte Springs, Florida, United States, 32714 | |
| Accelovance | |
| Melbourne, Florida, United States, 32935 | |
| University Family Healthcare, Pa | |
| Sarasota, Florida, United States, 34243 | |
| Premier Healthcare | |
| St. Petersburg, Florida, United States, 33707 | |
| United States, Kansas | |
| Pinnacle Medical Research | |
| Overland Park, Kansas, United States, 66215 | |
| United States, Missouri | |
| Kansas City University Of Medicine And Biosciences | |
| Kansas City, Missouri, United States, 64106 | |
| Primary Care Physicians, Pc | |
| Wentzville, Missouri, United States, 63385 | |
| United States, New Jersey | |
| Physicians Research Center | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New York | |
| Hudson Valley Clinical Research Center | |
| Kingston, New York, United States, 12401 | |
| United States, North Carolina | |
| Neem Research Group Of Charlotte | |
| Charlotte, North Carolina, United States, 28262 | |
| Diabetes Center- East Carolina University | |
| Greenville, North Carolina, United States, 27834 | |
| Crescent Medical Research | |
| Salisbury, North Carolina, United States, 28144 | |
| United States, Ohio | |
| Community Health Care, Inc. | |
| Barberton, Ohio, United States, 44203 | |
| Clinical Research Limited | |
| Canton, Ohio, United States, 44718 | |
| Wells Institute For Health Awareness | |
| Kettering, Ohio, United States, 45429 | |
| Clinical Research Source, Inc | |
| Perrysburg, Ohio, United States, 43551 | |
| United States, Oklahoma | |
| Accelovance | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Integris Family Care South | |
| Oklahoma City, Oklahoma, United States, 73170 | |
| United States, Oregon | |
| The Office Of Patricia Buchanan | |
| Eugene, Oregon, United States, 97404 | |
| United States, Pennsylvania | |
| Cumberland Valley Endocrinology Center, Llc | |
| Carlisle, Pennsylvania, United States, 17015 | |
| Fleetwood Clinical Research | |
| Fleetwood, Pennsylvania, United States, 19522 | |
| Banksville Medical, Pc | |
| Pittsburgh, Pennsylvania, United States, 15216 | |
| Biomedical Research Associates, Llc | |
| Shippensburg, Pennsylvania, United States, 17257 | |
| United States, South Carolina | |
| Middle Tyger Family Medicine | |
| Duncan, South Carolina, United States, 29334 | |
| Southeastern Research Assoc | |
| Taylors, South Carolina, United States, 29687 | |
| United States, Tennessee | |
| Versoza & Ungab Internal Medicine Associates | |
| Bartlett, Tennessee, United States, 38134 | |
| Collierville Medical Specialist | |
| Collierville, Tennessee, United States, 38017 | |
| Holston Medical Group | |
| Kingsport, Tennessee, United States, 37660 | |
| Southwind Medical Specialist | |
| Memphis, Tennessee, United States, 38125 | |
| Med-South Research | |
| Memphis, Tennessee, United States, 38116 | |
| United States, Texas | |
| Precision Family Medicine | |
| Carrollton, Texas, United States, 75010 | |
| Alpha Therapy Research Center | |
| Corpus Christi, Texas, United States, 78411 | |
| Village Family Practice | |
| Houston, Texas, United States, 77024 | |
| Texas Center For Drug Development, P.A. | |
| Houston, Texas, United States, 77081 | |
| Abbott Clinical Research Group, Inc | |
| San Antonio, Texas, United States, 78224 | |
| United States, Utah | |
| Taylor/Wade Medical | |
| Bountiful, Utah, United States, 84010 | |
| Optimum Clinical Research | |
| Salt Lake City, Utah, United States, 84102 | |
| United States, Virginia | |
| Tidewater Integrated Medical Research | |
| Virginia Beach, Virginia, United States, 23451 | |
| United States, Washington | |
| Spokane Internal Medicine | |
| Spokane, Washington, United States, 99216 | |
| India | |
| Local Institution | |
| Manipal, Karnataka, India, 576104 | |
| Local Institution | |
| Kochi, Kerala, India, 682026 | |
| Local Institution | |
| Attavar, Mangalore, India, 575001 | |
| Local Institution | |
| Sarita Vihar, New Delhi, India, 110076 | |
| Local Institution | |
| Bangalore, India, 560034 | |
| Local Institution | |
| Mumbai, India, 400007 | |
| Local Institution | |
| Mumbai, India, 400021 | |
| Local Institution | |
| Nagpur, India, 440012 | |
| Russian Federation | |
| Local Institution | |
| Moscov, Russian Federation, 118089 | |
| Local Institution | |
| Moscow, Russian Federation, 115487 | |
| Local Institution | |
| Nizhniy Novgorod, Russian Federation, 603126 | |
| Local Institution | |
| Saint Petersburg, Russian Federation, 198013 | |
| Local Institution | |
| Saratov, Russian Federation, 410018 | |
| Local Institution | |
| Saratov, Russian Federation, 410054 | |
| Local Institution | |
| Smolensk, Russian Federation, 214018 | |
| Local Institution | |
| St.Petersburg, Russian Federation, 194156 | |
| Local Institution | |
| Volgograd, Russian Federation, 400138 | |
| Taiwan | |
| Local Institution | |
| Changhua, Taiwan, 500 | |
| Local Institution | |
| Kaohsiung County, Taiwan, 833 | |
| Local Institution | |
| Taichung, Taiwan, 402 | |
| Local Institution | |
| Taichung City, Taiwan, 407 | |
| Local Institution | |
| Taipei City, Taiwan, 114 | |
| Local Institution | |
| Tao-Yuan County, Taiwan, 333 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00316082 History of Changes |
| Other Study ID Numbers: | CV181-038 |
| Study First Received: | April 18, 2006 |
| Results First Received: | August 17, 2009 |
| Last Updated: | November 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Saxagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013