A 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

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2013-004819-40-DE
• Date of registration: 14/02/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: A 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
• Scientific 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
• Date of first enrolment: 23/06/2014
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004819-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Canada, France, Germany, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen Pharmaceutica N.V.

• Name: Clinical Registry Group
• Affiliation: Janssen Pharmaceutica N.V.

Key inclusion & exclusion criteria

Inclusion criteria:
1.Must have a diagnosis of type 2 diabetes mellitus
2.Must have a screening HbA1c of >=7.5% to <=10.5%
3.Must be on metformin >=2000 mg/day (or >=1500 mg/day, if unable to tolerate higher doses of metformin) and sitagliptin 100 mg (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Type 2 Diabetes Mellitus with Inadequate Glycemic Control
MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Intervention(s)

Trade Name: Invokana
Product Name: Canagliflozin
Product Code: JNJ-28431754-ZAE
Pharmaceutical Form: Capsule
INN or Proposed INN: Canagliflozin
CAS Number: 928672-86-0
Current Sponsor code: JNJ-28431754-ZAE
Other descriptive name: CANAGLIFLOZIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Invokana
Product Name: Canagliflozin
Product Code: JNJ-28431754-ZAE
Pharmaceutical Form: Capsule
INN or Proposed INN: Canagliflozin
CAS Number: 928672-86-0
Current Sponsor code: JNJ-28431754-ZAE
Other descriptive name: CANAGLIFLOZIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): 1.Change from baseline in glycosylated hemoglobin
(HbA1c)
2.Evaluation of safety and tolerability of canagliflozin

Secondary Objective: In subjects with T2DM who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and on sitagliptin (or equivalent fixed dose combination) after 26 weeks of treatment:
•To assess the effect of canagliflozin relative to placebo on fasting plasma glucose (FPG)
•To assess the effect of canagliflozin relative to placebo on body weight
•To assess the effect of canagliflozin relative to placebo on the proportion of subjects with HbA1c <7.0%
•To assess the effect of canagliflozin relative to placebo on systolic blood pressure

Main Objective: In subjects with T2DM who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and on sitagliptin, after 26 weeks of treatment:
•To assess the effect of canagliflozin relative to placebo on HbA1c
•To assess the safety and tolerability of canagliflozin

Timepoint(s) of evaluation of this end point: 1.Day 1 (baseline), up to Week 26
2.Baseline, up to the end of post –treatment period, (approximately 28 weeks)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: -Baseline, up to Week 26

Secondary end point(s): 1.Change from baseline in fasting plasma glucose (FPG)
2.Change from baseline in percentage of body weight
3.Proportions of patients with HbA1c <7.0%
4.Change from baseline in systolic blood pressure (SBP)
5.Change from baseline in diastolic blood pressure (DBP)

Secondary ID(s)

28431754DIA4004

Source(s) of Monetary Support

Janssen Research and Development, LLC