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Completed

NCT Number: NCT02471404

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

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.

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Key information

Conditions

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

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Hodonín, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Main Inclusion Criteria:

  • Is male or female and ≥18 and <75 years old at time of informed consent.
  • Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
  • Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
  • Has a BMI of ≤45 kg/m2 at Enrolment visit.
  • 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:

  • 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.
  • 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.
  • 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.
  • Concomitant treatment with loop diuretics

Treatment and study plan

Dapagliflozin

Drug

10 mg, orally Green, plain, diamond-shaped, film-coated tablet

Other names: Forxiga

Saxagliptin

Drug

5 mg, orally Plain, yellow, biconvex, round, film-coated tablet

Other names: Onglyza™

Glimepiride

Drug

1, 2, or 4 mg, orally Opaque gray capsule

Other names: Amaryl

Placebo for dapagliflozin

Drug

Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet

Placebo for saxagliptin

Drug

Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet

Placebo for glimepiride

Drug

Does not contain active ingredient, orally. Opaque gray capsule

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2015
Registry last updated
Mar 26, 2019

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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