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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02009488

Run by

Janssen Research & Development, LLC

People needed

59

Starts

2014-09-08

Expected to finish

2017-01-03

Last updated by the study team

2018-01-04

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — San Diego, La Jolla, California, United States
• Study site — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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