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NCT Number: NCT02284893

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Baja, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saxagliptin

Drug

administered orally once daily

Dapagliflozin

Drug

administered orally once daily

Sitagliptin

Drug

administered orally once daily

Placebo matching with Saxagliptin

Drug

administered orally once daily

Placebo matching with Dapagliflozin

Drug

administered orally once daily

Placebo matching with Sitagliptin

Drug

administered orally once daily

Primary outcomes

  1. Mean Change in HbA1c

    Time frame: Baseline (randomization) to Week 26

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2014
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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