Phase 3 Completed N=444 Randomized Triple-blind Treatment

A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Diabetes

Source: ClinicalTrials.gov NCT02419612 ↗

Enrolled (actual)

444

Serious AEs

12.0%

Results posted

Oct 2018

Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 — -1.35; -0.98 % HbA1c — p=<0.001

Summary

This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52	-1.35; -0.98	<0.001 sig
SECONDARY Change From Baseline in Total Body Weight at Week 52	-3.11; 0.95	<0.001 sig
SECONDARY Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52	44.3; 34.3	0.044 sig
SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) at Week 52	-2.6; 1.0	0.007 sig
SECONDARY Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period	1.3; 8.8	0.002 sig
SECONDARY Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.	37.0; 55.6	<0.001 sig
SECONDARY Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156	21.4; 11.7	0.006 sig
SECONDARY Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.	NA; 92.3	<0.001 sig

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

Subjects must be willing and able to give signed and dated written informed consent
Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control
Subjects should have been taking the same daily dose of metformin ≥ 1500 mg
Fasting Plasma Glucose ≤ 270 mg/dL (≤15 mmol/L)
Males and females, aged ≥18 years old at time of screening visit
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
WOCBP and males must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug

Exclusion Criteria

Clinical diagnosis of type I diabetes
History of diabetic ketoacidosis
Cardiovascular/vascular diseases within 3 months of the enrollment
Renal disease
Hepatic diseases
History of, or currently, acute or chronic pancreatitis
Hematological and oncological disease/conditions
Patients who have contraindications to therapy being studied
Patients on weight loss program(s)
Replacement or chronic systemic corticosteroid therapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02419612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.