Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
This study is currently recruiting participants.
Verified November 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01646320
First received: July 18, 2012
Last updated: March 28, 2013
Last verified: November 2012
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Purpose
The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Dapagliflozin Drug: Placebo matching with Dapagliflozin Drug: Saxagliptin Drug: Metformin immediate release (IR) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxagliptin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Saxagliptin |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Mean change from baseline in Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline (Day 1) ] [ Designated as safety issue: No ]
- Mean change from baseline in Glycosylated hemoglobin (HbA1c) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline (Day 1) and Week 24 ] [ Designated as safety issue: No ]
- Mean change from baseline in 2-hour post-prandial glucose during a liquid meal tolerance test (2-h MTT) [ Time Frame: Baseline (Day 1) and Week 24 ] [ Designated as safety issue: No ]
- Mean change from baseline in total body weight [ Time Frame: Baseline (Day 1) and Week 24 ] [ Designated as safety issue: No ]
- Percent of subjects achieving a therapeutic glycemic response, defined as a HbA1c < 7.0% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 280 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR |
Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
Drug: Saxagliptin
Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
Other Name: Onglyza
Drug: Metformin immediate release (IR)
Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks
|
| Experimental: Arm 2: Placebo + Saxagliptin + Metformin IR |
Drug: Placebo matching with Dapagliflozin
Tablets, Oral, 0 mg, Once daily, Up to 52 weeks
Drug: Saxagliptin
Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
Other Name: Onglyza
Drug: Metformin immediate release (IR)
Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks
|
Detailed Description:
Prior to randomization, all eligible subjects will receive open-label treatment with Saxagliptin 5mg and Metformin IR during the 16-week open-label treatment period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females, ≥ 18 years old, with type 2 diabetes with inadequate glycemic control HbA1c ≥ 7.5% - ≤ 11.5%
- Stable dose of Metformin for at least 8 weeks
- C-peptide ≥ 1.0 ng/mL
- Body Mass Index ≤ 45.0 kg/m2
Exclusion Criteria:
- Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2 or serum creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
- Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0 times the upper limit of normal (ULN)
- Serum total bilirubin > 2.5 x ULN
- Systolic blood pressure (SBP) ≥ 160 mmHg and/or Diastolic blood pressure (DBP) ≥ 100mmHg
- Cardiovascular disease within 3 months of the screening visit
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646320
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Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Hide Study LocationsLocations
| United States, Arizona | |
| Clinical Research Advantage Inc/Desert Clinical Research Llc | Recruiting |
| Mesa, Arizona, United States, 85213 | |
| Contact: Gerald Shockey, Site 0004 480-898-1300 | |
| Elite Clinical Studies, Llc | Recruiting |
| Phoenix, Arizona, United States, 85018 | |
| Contact: Joseph Lillo, Site 0094 602-788-3437 | |
| Stonecreek Medical Associates, Pc/Clinical Research Advantag | Recruiting |
| Phoenix, Arizona, United States, 85028 | |
| Contact: Thomas Bauch, Site 0006 602-386-3480 | |
| United States, Arkansas | |
| Local Institution | Not yet recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Site 0099 | |
| United States, California | |
| Cassidy Medical Group/Clinical Research Advantage | Recruiting |
| Vista, California, United States, 92083 | |
| Contact: Terry Haas, Site 0002 760-477-7882 | |
| United States, Florida | |
| Palm Springs Research Institute | Recruiting |
| Hialeah, Florida, United States, 33012 | |
| Contact: Farid Marquez, Site 0021 305-827-3335 | |
| International Research Associates, Llc | Recruiting |
| Miami, Florida, United States, 33183 | |
| Contact: Cristian Breton, Site 0034 305-670-8830 | |
| Local Institution | Not yet recruiting |
| Oviedo, Florida, United States, 32765 | |
| Contact: Site 0098 | |
| United States, Nebraska | |
| Local Institution | Not yet recruiting |
| Fremont, Nebraska, United States, 68025 | |
| Contact: Site 0005 | |
| United States, North Carolina | |
| Metrolina Internal Medicine | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Latimer Taylor, Site 0012 704-374-0030 | |
| United States, Ohio | |
| Sterling Research Grp, Ltd. | Recruiting |
| Cincinnati, Ohio, United States | |
| Contact: Curtis Taylor, Site 0038 513-381-4100 | |
| United States, Texas | |
| Sam Clinical Research Center | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Sam Miller, Site 0033 | |
| United States, Virginia | |
| Tidewater Integrated Medical Research | Recruiting |
| Virginia Beach, Virginia, United States, 23454 | |
| Contact: Gregory Haase, Site 0092 757-233-9280 | |
| Czech Republic | |
| Local Institution | Recruiting |
| Pardubice, Czech Republic, 530 02 | |
| Contact: Site 0047 | |
| Local Institution | Recruiting |
| Praha 10, Czech Republic, 100 00 | |
| Contact: Site 0089 | |
| Local Institution | Recruiting |
| Praha 4, Czech Republic, 149 00 | |
| Contact: Site 0081 | |
| Mexico | |
| Local Institution | Recruiting |
| Guadalajara, Jalisco, Mexico, 44670 | |
| Contact: Site 0077 | |
| Local Institution | Recruiting |
| Zapopan, Jalisco, Mexico, 45116 | |
| Contact: Site 0095 | |
| Local Institution | Recruiting |
| Zapopan, Jalisco, Mexico, 45200 | |
| Contact: Site 0074 | |
| Local Institution | Recruiting |
| Monterrey, Nuevo Leon, Mexico, 64020 | |
| Contact: Site 0075 | |
| Local Institution | Recruiting |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Contact: Site 0076 | |
| Local Institution | Recruiting |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Contact: Site 0078 | |
| Local Institution | Recruiting |
| Aguascalientes, Mexico, 20127 | |
| Contact: Site 0096 | |
| Poland | |
| Local Institution | Not yet recruiting |
| Bialystok, Poland, 15-435 | |
| Contact: Site 0080 | |
| Local Institution | Not yet recruiting |
| Poznan, Poland, 61-655 | |
| Contact: Site 0067 | |
| Local Institution | Not yet recruiting |
| Szczecin, Poland, 71-455 | |
| Contact: Site 0064 | |
| Local Institution | Not yet recruiting |
| Warszawa, Poland, 03-003 | |
| Contact: Site 0065 | |
| Local Institution | Not yet recruiting |
| Warszawa, Poland, 01-868 | |
| Contact: Site 0068 | |
| Local Institution | Recruiting |
| Zory, Poland, 44-240 | |
| Contact: Site 0069 | |
| Romania | |
| Local Institution | Not yet recruiting |
| Bucharest, Romania, 010825 | |
| Contact: Site 0073 | |
| Local Institution | Not yet recruiting |
| Bucharest, Romania, 070208 | |
| Contact: Site 0052 | |
| Local Institution | Not yet recruiting |
| Constanta, Romania, 900591 | |
| Contact: Site 0053 | |
| Local Institution | Not yet recruiting |
| Constanta, Romania, 900591 | |
| Contact: Site 0051 | |
| Local Institution | Not yet recruiting |
| Craiova, Romania, 200349 | |
| Contact: Site 0054 | |
| Local Institution | Not yet recruiting |
| Galati, Romania, 800098 | |
| Contact: Site 0050 | |
| Russian Federation | |
| Local Institution | Not yet recruiting |
| Kursk, Russian Federation, 305035 | |
| Contact: Site 0063 | |
| Local Institution | Not yet recruiting |
| Moscow, Russian Federation, 119034 | |
| Contact: Site 0072 | |
| Local Institution | Not yet recruiting |
| Saint-petersburg, Russian Federation, 191015 | |
| Contact: Site 0056 | |
| Local Institution | Not yet recruiting |
| Saint-Petersburg, Russian Federation, 194044 | |
| Contact: Site 0093 | |
| Local Institution | Not yet recruiting |
| St. Petersburg, Russian Federation, 195257 | |
| Contact: Site 0062 | |
| Local Institution | Not yet recruiting |
| St. Petersburg, Russian Federation, 197136 | |
| Contact: Site 0060 | |
| Local Institution | Not yet recruiting |
| St. Petersburg, Russian Federation, 194044 | |
| Contact: Site 0059 | |
| Local Institution | Not yet recruiting |
| St.petersburg, Russian Federation, 179089 | |
| Contact: Site 0058 | |
| Local Institution | Not yet recruiting |
| St.petersburg, Russian Federation, 195112 | |
| Contact: Site 0061 | |
| Local Institution | Not yet recruiting |
| Yaroslaval, Russian Federation, 150062 | |
| Contact: Site 0055 | |
| Turkey | |
| Local Institution | Not yet recruiting |
| Ankara, Turkey, 06500 | |
| Contact: Site 0049 | |
| Local Institution | Not yet recruiting |
| Antalya, Turkey, 07070 | |
| Contact: Site 0048 | |
| Local Institution | Not yet recruiting |
| Istanbul, Turkey, 34390 | |
| Contact: Site 0039 | |
| Local Institution | Suspended |
| Istanbul, Turkey, 34398 | |
| Local Institution | Not yet recruiting |
| Izmir, Turkey, 35340 | |
| Contact: Site 0045 | |
| United Kingdom | |
| Local Institution | Recruiting |
| Portsmouth, Hants, United Kingdom, PO3 6LY | |
| Contact: Site 0083 | |
| Local Institution | Recruiting |
| Newport, Isle of Wight, United Kingdom, PO30 5TG | |
| Contact: Site 0090 | |
| Local Institution | Not yet recruiting |
| Liverpool, Merseyside, United Kingdom, L7 8XP | |
| Contact: Site 0085 | |
| Local Institution | Recruiting |
| Chippenham, Wiltshire, United Kingdom, SN15 1HP | |
| Contact: Site 0091 | |
| Local Institution | Recruiting |
| Bedfordshire, United Kingdom, SG19 3JR | |
| Contact: Site 0086 | |
| Local Institution | Recruiting |
| London, United Kingdom, W6 7HY | |
| Contact: Site 0088 | |
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01646320 History of Changes |
| Other Study ID Numbers: | MB102-129, 2011-006324-20 |
| Study First Received: | July 18, 2012 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Canada: Health Canada Mexico: Federal Commission for Protection Against Health Risks |
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