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Completed

NCT Number: NCT02551874

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

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

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Key information

Conditions

Type 2 Diabetes Mellitus 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, Karlovy Vary, Czechia

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About this study

CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

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

  • At least 18 years of age at screening
  • HbA1c ≥ 8% and ≤ 12% at screening
  • Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)
  • Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks
  • estimated glomerular filtration rate (eGFR) < 60 ml/ml/1.73m2
  • Body Mass Index ≤ 45.0 kg/m2

Exclusion criteria

  • Clinical diagnosis of Type 1 diabetes
  • History of ketoacidosis
  • Renal, hepatic or pancreatic disease
  • Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min
  • Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min

Treatment and study plan

Saxagliptin, Onglyza

Drug

Tablets, Oral, 5mg , Once daily, 24 weeks

Other names: Onglyza

Dapagliflozin, Farxiga

Drug

Tablets, Oral, 10mg , Once daily, 24 weeks

Other names: BMS-512148

Glargine insulin

Drug

100 Units/ml solution for injection in a prefilled SoloStar pen

Other names: Lantus

metformin

Drug

Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks

Other names: Glucophage

Primary outcomes

  1. Mean Change From Baseline in HbA1c at Week 24

    Time frame: Baseline and Week 24

    To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

Secondary outcomes

  1. Mean Change From Baseline in Total Body Weight at Week 24

    Time frame: Baseline and Week 24

    To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment

  2. Percentage of Subjects With Confirmed Hypoglycaemia at Week 24

    Time frame: Baseline and Week 24

    Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L)

  3. Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24

    Time frame: Baseline and Week 24

    To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

  4. Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24

    Time frame: Baseline and Week 24

    To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

  5. Change From Baseline in the Mean Value of 24-hour Glucose at Week 2

    Time frame: Baseline and Week 2

    Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, 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 With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin With or Without Sulfonylurea Therapy

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2015
Registry last updated
Dec 11, 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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