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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

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ClinicalTrials.gov Identifier: NCT02284893
Recruitment Status : Completed
First Posted : November 6, 2014
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Saxagliptin Drug: Dapagliflozin Drug: Sitagliptin Drug: Placebo matching with Saxagliptin Drug: Placebo matching with Dapagliflozin Drug: Placebo matching with Sitagliptin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period 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
Actual Study Start Date : September 9, 2014
Actual Primary Completion Date : September 20, 2016
Actual Study Completion Date : September 20, 2016


Arm Intervention/treatment
Experimental: A1:Saxagliptin / Placebo + Dapagliflozin / Placebo
Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily)
Drug: Saxagliptin
administered orally once daily

Drug: Dapagliflozin
administered orally once daily

Drug: Placebo matching with Saxagliptin
administered orally once daily

Drug: Placebo matching with Dapagliflozin
administered orally once daily

Experimental: A2: Sitagliptin / placebo
Sitagliptin 100 mg and matching placebo 0 mg (once daily)
Drug: Sitagliptin
administered orally once daily

Drug: Placebo matching with Sitagliptin
administered orally once daily




Primary Outcome Measures :
  1. Mean Change in HbA1c [ Time Frame: Baseline (randomization) to Week 26 ]

Secondary Outcome Measures :
  1. Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0% [ Time Frame: week 26 ]
  2. Mean Change in Total Body Weight [ Time Frame: Baseline (randomization) to Week 26 ]
  3. Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline (randomization) to Week 26 ]


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit
  • Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening
  • BMI > 20.0 kg/m2 at the enrollment visit
  • Males and Females, age ≥18 years old at time of screening visit
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
  • Women must not be breastfeeding

Exclusion Criteria:

  • Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus
  • History of diabetic ketoacidosis
  • Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit

    • Myocardial infarction
    • Cardiac surgery or revascularization (coronary artery bypass surgery Coronary Artery Bypass Graft [(CABG)]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty [(PTCA)])
    • Unstable angina
    • Unstable congestive heart failure (CHF)
    • Transient ischemic attack (TIA) or significant cerebrovascular disease
    • Unstable or previously undiagnosed arrhythmia
    • Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%
  • Renal Disease
  • Hepatic Diseases
  • Hematological and Oncological Disease/Conditions
  • Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women
  • Abnormal Free T4

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284893


Locations
Show Show 79 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Astra Zeneca AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02284893    
Other Study ID Numbers: CV181-363
2014-001102-17 ( EudraCT Number )
First Posted: November 6, 2014    Key Record Dates
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Dapagliflozin
Saxagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sodium-Glucose Transporter 2 Inhibitors