Clinical trial NCT02025907: A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
Official title: A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Canagliflozin
Hemoglobin A1c
Metformin
Sitagliptin
T2DM
JNJ-28431754
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-01-01
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

Detailed description: This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin \>=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).

Eligibility criteria: Inclusion Criteria:

* Must have a diagnosis of type 2 diabetes mellitus
* Must have a screening HbA1c of \>=7.5% to \<=10.5%
* Must be on metformin \>=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening

Exclusion Criteria:

* History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
* A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
* eGFR \<60 ml/min/1.73m2, or serum creatinine \>=1.4 mg/dL for men and \>=1.3 mg/dL for women
* Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
* Major surgery (ie, requiring general anesthesia) within 12 weeks before screening

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
timeFrame: Baseline and Week 26
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: Baseline and Week 26
measure: Percent Change From Baseline in Body Weight at Week 26
timeFrame: Baseline and Week 26
measure: Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26
timeFrame: Week 26
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Northridge
country: United States
state: California
city: Norwalk
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: San Ramon
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Cooper City
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Perry
country: United States
state: Georgia
city: Shawnee Mission
country: United States
state: Kansas
city: Marrero
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Metarie
country: United States
state: Louisiana
city: Rockville
country: United States
state: Maryland
city: Jackson
country: United States
state: Mississippi
city: Picayune
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Nashua
country: United States
state: New Hampshire
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Arlington
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugarland
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Coffs Harbour
country: Australia
city: Freemantle
country: Australia
city: Geelong
country: Australia
city: Heidelberg
country: Australia
city: Herston
country: Australia
city: Melbourne
country: Australia
city: Merewether
country: Australia
city: Sherwood
country: Australia
city: Sydney
country: Australia
city: Wollongong
country: Australia
city: Brampton
country: Canada
state: Ontario
city: Hawkesbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: La Rochelle Cedex 1 Poitou-Cha
country: France
city: La Tronche
country: France
city: Nancy
country: France
city: Narbonne Cedex
country: France
city: Nice Cedex 3
country: France
city: Paris Cedex 15
country: France
city: Venissieux
country: France
city: Freiburg
country: Germany
city: Fulda
country: Germany
city: Hamburg
country: Germany
city: Münster
country: Germany
city: Neuwied
country: Germany
city: Pirna
country: Germany
city: Speyer
country: Germany
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.