Status:
COMPLETED
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in pati...
Detailed Description
This study will be a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), active-controlled (one of t...
Eligibility Criteria
Inclusion
- Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
- Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
- Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
- Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization
- Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization
Exclusion
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation
- Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Key Trial Info
Start Date :
June 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2014
Estimated Enrollment :
1186 Patients enrolled
Trial Details
Trial ID
NCT01809327
Start Date
June 4 2013
End Date
December 2 2014
Last Update
July 11 2017
Active Locations (129)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States
2
Phoenix, Arizona, United States
3
Encinitas, California, United States
4
Newport Beach, California, United States