CompletedNCT01381887Updated Apr 22, 2013

A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus

A Phase 1 interventional study of Placebo and Canagliflozin 300mg/Placebo in Diabetes Mellitus, Type 2, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 5 sites in United States. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-04-22.

Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Ages: 25 Years to 70 Years
Sex: All

Study summary

The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose blood levels in patients with Type 2 Diabetes Mellitus.

Read the detailed description

This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin in patients with Type 2 Diabetes Mellitus (T2DM) who are currently taking metformin at a stable dose of >=1500 mg/day. Patients will participate in the study for up to approximately 16 weeks. During the study, patients will receive 4 treatments (A, B, C, and D); each treatment will be administered during a 3-day treatment period. Patients will receive 1 dose of study medication in the morning of Day 1 and Day 2 of each treatment period and treatment periods will be separated by approximately 2 weeks. Treatments will consist of placebo (A), canagliflozin 300 mg and placebo (B), canagliflozin 300mg (C), and canagliflozin 300mg and canagliflozin 150mg (D).

Conditions studied

Diabetes Mellitus, Type 2

Browse trials for

Diabetes Mellitus, Type 2 9,589

Keywords

Canagliflozin
Placebo
Type 2 diabetes mellitus

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 37 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 465 studies on the registry; none are open to participants now.

Browse Johnson & Johnson Pharmaceutical Research & Development, L.L.C. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements >=130 mg/dL and \<=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea [SU] or a meglitinide or a dipeptidyl peptidase-4 [DPP-4] inhibitor) are eligible for enrollment in the study.

Exclusion criteria

Exclusion Criteria:

History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
history of a severe hypoglycemic episode within 6 months before screening
Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
History of or current illness considered to be clinically significant by the investigator

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 37 participants (actual)

Study arms

Placebo comparator
001
Placebo Treatment A: Form=capsule route=oral administration. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
Drug: Placebo
Experimental
002
Canagliflozin 300mg/Placebo Treatment B: Type=1 unit=mg number=300 form=capsule route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods. Form=capsule route=oral administration. Capsule is taken once on Day 2 in 1 of 4 treatment periods.
Drug: Canagliflozin 300mg/Placebo
Experimental
003
Canagliflozin 300mg Treatment C: Type=1 unit=mg number=300 form=capsule route=oral use. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
Drug: Canagliflozin 300mg
Experimental
004
Canagliflozin 300mg/Canagliflozin 150mg Treatment D: Type=1 unit=mg number=300 form=capsule route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods. Type=1 unit=mg number=150 form=capsule route=oral use. Capsule is taken once on Day 2 in 1 of 4 treatment periods.
Drug: Canagliflozin 300mg/Canagliflozin 150mg

Interventions

DrugPlacebo
Treatment A: Form=capsule, route=oral administration. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
DrugCanagliflozin 300mg/Placebo
Treatment B: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods. Form=capsule, route=oral administration. Capsule is taken once on Day 2 in 1 of 4 treatment periods.
DrugCanagliflozin 300mg/Canagliflozin 150mg
Drug page: Canagliflozin
Treatment D: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods. Type=1, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once on Day 2 in 1 of 4 treatment periods.
DrugCanagliflozin 300mg
Treatment C: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.

What researchers measure

Primary outcomes

Plasma concentrations of glucose
Time frame: Up to Day 44

Secondary outcomes

Rate of insulin secretion
Time frame: Up to Day 44
Urinary glucose excretion (UGE)
Time frame: Up to Day 44
Renal threshold of glucose excretion (RTG)
Time frame: Up to Day 44
Adverse events
Time frame: Up to approximately Day 44

Study locations

5 sites

Chula Vista, California, United States
Miramar, Florida, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
San Antonio, Texas, United States

References and documents

Publications

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2. PubMed 38770818 ↗
Stein P, Berg JK, Morrow L, Polidori D, Artis E, Rusch S, Vaccaro N, Devineni D. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, reduces post-meal glucose excursion in patients with type 2 diabetes by a non-renal mechanism: results of a randomized trial. Metabolism. 2014 Oct;63(10):1296-303. doi: 10.1016/j.metabol.2014.07.003. Epub 2014 Jul 9. PubMed 25110280 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Nov 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 9, 2011
First posted: Jun 27, 2011
Start: Jun 2011
Primary completionActual: Nov 2011
CompletionActual: Nov 2011
Last update: Apr 22, 2013

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01381887
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible party: Sponsor
First posted: Jun 27, 2011
Start date: Jun 2011
Primary completion: Nov 2011
Completion: Nov 2011
Last update: Apr 22, 2013

Study contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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