A Study of Two Methods for Determining the Renal Threshold for Glucose in Patients With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Canagliflozin

• Registration Number: NCT01273558
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to compare the results from two methods used to determine the renal threshold for glucose excretion (defined as the lowest plasma glucose concentration at which appreciable amounts of glucose appear in the urine) in untreated patients with type 2 diabetes mellitus and in patients with type 2 diabetes mellitus who are treated with 100 mg once-daily canigliflozin for 8 days.

Detailed Description

This is an open-label (patients will know if they are receiving treatment and the identity of the treatment) study that will compare renal threshold of glucose (RTG) values obtained by 2 different methods: an established method (ie, the stepwise hyperglycemic clamp method) and a new method (the mixed meal tolerance test \[MMTT\] method). The RTG is defined as the lowest plasma glucose concentration at which appreciable amounts of glucose appear in the urine. Each method for determining the RTG value will be performed in untreated patients with type 2 diabetes mellitus (T2DM) and in patients with T2DM who are treated with canagliflozin 100 mg once daily for 8 days. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will not take study drug (canagliflozin 100 mg overencapsulated tablets) in Part 1 of the study. In Part 2 of the study, patients will take study drug once daily on Study Days 1 through 8.

Study Timeline

• Study First Submitted: 2010-12-10
• Study Start: 2011-01
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Study Completion: 2011-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-19
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients with T2DM who are not receiving treatment with any anti-hyperglycemic agents (AHAs) for at least 12 weeks, or who are receiving treatment with a stable dose and regimen of metformin monotherapy for at least 12 weeks and have a hemoglobin A1c (HbA1c) in the range of >=7% to <=10%

Exclusion Criteria

• History of Type 1, "brittle" diabetes or secondary forms of diabetes
• History of 1 or more severe hypoglycemic episodes
• History of diabetic complications considered to be clinically significant by the Investigator
• History of or current illness considered to be clinically significant by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2: canagliflozin	Canagliflozin	In Part 2 of the study, patients will receive canagliflozin once daily on Days 1 through 8.

Primary Outcome Measures

Name	Time	Method
RTG values using the MMTT and the stepwise hyperglycemic clamp methods	On Days 7 and 8 (Part 2)

Secondary Outcome Measures

Name	Time	Method
Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure	On Days 7 and 8 (Part 2)
Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure	On Days 7 and 8 (Part 2)