Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Trial end date: 2017-01-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess changes from baseline in insulin sensitivity, hepatic fat content and beta cell function after approximately 24-25 weeks of treatment with canagliflozin compared to placebo in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic (blood sugar) control on metformin monotherapy or on combination therapy with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Canagliflozin; Insulin

Criteria

Inclusion Criteria:

• Must have a diagnosis of T2DM for at least 3 months and be on either metformin monotherapy at a stable dose of >=1,000 mg per day or on combination therapy of metformin >=1,000 mg per day and a DPP-4 inhibitor at stable daily doses for at least 12 weeks prior to screening with an HbA1c of >=7.0% and <= 9.5% at Screening

• Fasting plasma glucose >=120 mg/dL and <=240 mg/dL at the Week -4 visit

• Fasting fingerstick glucose >=120 mg/dL and <=240 mg/dL performed at clinical research center on Day -14

• Must be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion Criteria:

• Has a history of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

• Has claustrophobia or anxiety, related to previous negative experiences with magnetic resonance imaging procedures which cannot be managed with an anxiolytic drug

• Has a history of brittle or labile glycemic control, with widely varying glucose measurements

• Has proliferative diabetic retinopathy (based on an eye examination within one year prior to Screening), currently receiving or requiring treatment

• Has a history of 1 or more severe hypoglycemic episodes within 6 months before screening

• Has history of hereditary glucose-galactose malabsorption or primary renal glucosuria.