A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea
This study has been completed.
Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01381900
First received: June 23, 2011
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to assess the safety, tolerability, and efficacy of the addition of canagliflozin relative to the addition of placebo in patients with inadequate glycemic control on metformin alone or in combination with a sulphonylurea.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Placebo Drug: Canagliflozin 100mg Drug: Canagliflozin 300mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week 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 Alone or in Combination With a Sulphonylurea |
Resource links provided by NLM:
Further study details as provided by Janssen Research & Development, LLC:
Primary Outcome Measures:
- Change in hemoglobin A1c (HbA1c) [ Time Frame: From baseline at Week 18 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fasting plasma glucose (FPG) [ Time Frame: From baseline to Week 18 ] [ Designated as safety issue: No ]
- Percent change in body weight [ Time Frame: From baseline to Week 18 ] [ Designated as safety issue: No ]
- Proportions of patients with HbA1c <7.0% and <6.5% [ Time Frame: At Week 18 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Up to approximately 20 weeks (includes 2 week single blind placebo run-in period and 18 week double-blind treatment period) ] [ Designated as safety issue: No ]
| Enrollment: | 678 |
| Study Start Date: | August 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
Canagliflozin 100mg Type=1 unit=mg number=100 form=capsule route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
|
Drug: Canagliflozin 100mg
Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
|
|
Experimental: 002
Canagliflozin 300mg Type=1 unit=mg number=300 form=capsule route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
|
Drug: Canagliflozin 300mg
Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
|
|
Placebo Comparator: 003
Placebo Form=capsule route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
|
Drug: Placebo
Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
|
Detailed Description:
This is a double-blind (neither study staff or the patient will know the identity of the treatment assigned) study of canagliflozin where Chinese and other Asian adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control on metformin alone or in combination with a sulphonylurea (SU) will be randomized (assigned to 1 of 3 treatments by chance) to receive the addition of treatment with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, or matching placebo capsules (placebo is a treatment identical in appearance to canagliflozin but does not contain active drug). All patients will take orally (by mouth) 1 single-blind placebo capsule once daily before the first meal of the day for up to 2 weeks (last dose of single-blind placebo to be taken the day before the baseline (Day 1) visit. On Day 1, patients will take orally, once daily 1 capsule of canagliflozin 100 mg, canagliflozin 300 mg, or placebo before the first meal of the day for up to 18 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with T2DM with inadequate glycemic control on metformin monotherapy or on metformin in combination with an SU at protocol-specified doses and having HbA1c >=7.0% and <=10.5% at Week -2 are eligible for enrollment in the study.
Exclusion Criteria:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
- History of a severe hypoglycemic episode within 6 months before screening
- History of or current illness considered to be clinically significant by the investigator
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381900
Locations
| China | |
| Baotou, China | |
| Beijing, China | |
| Changchun, China | |
| Chengdu, China | |
| Chongqing, China | |
| Guangzhou, China | |
| Hangzhou, China | |
| Harbin, China | |
| Nanchang, China | |
| Nanjing, China | |
| Nanning, China | |
| Shanghai, China | |
| Shenyang, China | |
| Shiyan, China | |
| Siping, China | |
| Su Zhou, China | |
| Tianjin, China | |
| Wuxi, China | |
| Xi'An, China | |
| Malaysia | |
| Kota Bharu, Malaysia | |
| Pulau Pinang, Malaysia | |
| Selangor, Malaysia | |
| Vietnam | |
| Hanoi, Vietnam | |
| Ho Chi Minh, Vietnam | |
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
| Study Director: | Janssen Research & Development, LLC C. Clinical Trial | Janssen Research & Development, LLC |
More Information
No publications provided
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01381900 History of Changes |
| Other Study ID Numbers: | CR018541, 28431754DIA3014 |
| Study First Received: | June 23, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Janssen Research & Development, LLC:
|
Canagliflozin Placebo Type 2 diabetes mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013