Overview

This trial is active, not recruiting.

Conditions type 2 diabetes mellitus,, inadequate glycaemic control
Treatments dapagliflozin, saxagliptin, glimepiride, placebo for dapagliflozin, placebo for saxagliptin, placebo for glimepiride
Phase phase 4
Sponsor AstraZeneca
Start date September 2015
End date March 2017
Trial size 930 participants
Trial identifier NCT02471404, D1689C00014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Dapagliflozin + saxagliptin placebo + glimepiride placebo + metformin
dapagliflozin Forxiga
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule
(Active Comparator)
Dapagliflozin + saxagliptin + glimepiride placebo+ metformin
dapagliflozin Forxiga
10 mg, orally Green, plain, diamond-shaped, film-coated tablet
saxagliptin Onglyza™
5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
placebo for glimepiride
Does not contain active ingredient, orally. Opaque gray capsule
(Active Comparator)
Glimepiride + dapagliflozin placebo + saxagliptin placebo + metformin
glimepiride Amaryl
1, 2, or 4 mg, orally Opaque gray capsule
placebo for dapagliflozin
Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
placebo for saxagliptin
Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet

Primary Outcomes

Measure
Change in hemoglobin A1c (HbA1c) from baseline to end of treatment
time frame: Measured at relevant visits from Baseline (Week 0) to Week 52

Secondary Outcomes

Measure
Proportion of patients reporting at least one episode of hypoglycaemia (symptomatic + blood glucose ≤50 mg/dL [2.8 mmol/L]) during the double-blind treatment period
time frame: During the 52-week treatment
Change in total body weight from baseline (Week 0) to Week 52
time frame: During the 52-week treatment
Change in FPG from baseline (Week 0) to Week 52
time frame: During the 52-week treatment
Time to rescue (insulin intake) during the 52-week double-blind treatment period
time frame: During the 52-week treatment

Eligibility Criteria

Male or female participants from 18 years up to 74 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.