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Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471404
Recruitment Status : Completed
First Posted : June 15, 2015
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Inadequate Glycaemic Control Drug: Dapagliflozin Drug: Saxagliptin Drug: Glimepiride Drug: Placebo for dapagliflozin Drug: Placebo for saxagliptin Drug: Placebo for glimepiride Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 939 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy
Actual Study Start Date : September 21, 2015
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : March 13, 2017


Arm Intervention/treatment
Active Comparator: Dapagliflozin+metformin
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
Drug: Dapagliflozin
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
Other Name: Forxiga

Drug: Placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet

Drug: Placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule

Active Comparator: Dapagliflozin+saxagliptin+metformin
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
Drug: Dapagliflozin
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
Other Name: Forxiga

Drug: Saxagliptin
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
Other Name: Onglyza™

Drug: Placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule

Active Comparator: Glimepiride+metformin
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
Drug: Glimepiride
1, 2, or 4 mg, orally Opaque gray capsule
Other Name: Amaryl

Drug: Placebo for dapagliflozin
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet

Drug: Placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet




Primary Outcome Measures :
  1. Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 [ Time Frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis ]
    Change in HbA1c from baseline (week 0) to week 52.


Secondary Outcome Measures :
  1. Patients With at Least One Episode of Confirmed Hypoglycaemia [ Time Frame: Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis ]
    Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period

  2. Change in Total Body Weight From Baseline at Week 52 [ Time Frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis ]
    Change in body weight from baseline (week 0) to week 52

  3. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52 [ Time Frame: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis ]
    Change in FPG from baseline (week 0) to week 52

  4. Time to Rescue [ Time Frame: Over the 52 week treatment period ]
    The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period

  5. Number of Patients Rescued [ Time Frame: Over the 52 week treatment period ]
    Number (%) of patients rescued.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Main Inclusion Criteria:

  1. Is male or female and ≥18 and <75 years old at time of informed consent.
  2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
  3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
  4. Has a BMI of ≤45 kg/m2 at Enrolment visit.
  5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.

Main, Exclusion Criteria:

  1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
  2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
  3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
  4. Concomitant treatment with loop diuretics

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): NCT02471404


Locations
Show Show 173 study locations
Sponsors and Collaborators
AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Statistical Analysis Plan  [PDF] March 21, 2017
Study Protocol  [PDF] January 12, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02471404    
Other Study ID Numbers: D1689C00014
First Posted: June 15, 2015    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019
Keywords provided by AstraZeneca:
Diabetes Mellitus Type 2,
metformin,
saxagliptin,
dapagliflozin,
glimepiride,
inadequate glycaemic control
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Glimepiride
Saxagliptin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors