Clinical trial NCT01340664: An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Canagliflozin
Placebo
Metformin
Hemoglobin A1c
Type 2 diabetes mellitus
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Detailed description: This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout the study.

Eligibility criteria: Inclusion Criteria:

* All patients must have a diagnosis of T2DM and be currently treated with metformin
* Patients in the study must have a HbA1c between \>=7 and \<=10.5%
* Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 18
timeFrame: Day 1 (Baseline) and Week 18
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
timeFrame: Day 1 (Baseline) and Week 18
measure: Percent Change in Body Weight From Baseline to Week 18
timeFrame: Day 1 (Baseline) and Week 18
measure: Percentage of Patients With HbA1c <7% at Week 18
timeFrame: Week 18
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: National City
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Marianna
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: Avon
country: United States
state: Indiana
city: Valparaiso
country: United States
state: Indiana
city: Madisonville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Charlotte
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Perrysburg
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Yukon
country: United States
state: Oklahoma
city: Oregon City
country: United States
state: Oregon
city: Pittsburg
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Pearland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Virginia Beach
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: St. John'S
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Brampton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Beroun
country: Czech Republic
city: Olomouc 9
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Pisek
country: Czech Republic
city: Prague 10
country: Czech Republic
city: Praha 11
country: Czech Republic
city: Znojmo
country: Czech Republic
city: Aguascalientes
country: Mexico
city: Guadalajara, Jalisco.
country: Mexico
city: Monterrey
country: Mexico
city: Tampico
country: Mexico
city: Bacau
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Galati
country: Romania
city: Targu Mures
country: Romania
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Tyumen
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Presov
country: Slovakia
city: Sahy
country: Slovakia
city: Trebisov
country: Slovakia
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Qiu R, Capuano G, Meininger G. Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus. J Clin Transl Endocrinol. 2014 May 5;1(2):54-60. doi: 10.1016/j.jcte.2014.04.001. eCollection 2014 Jun.