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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: no Intervention

In Part 1 of the study, patients will not receive any study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Part 2: canagliflozin

In Part 2 of the study, patients will receive canagliflozin once daily on Days 1 through 8.

Group Type EXPERIMENTAL

Canagliflozin

Intervention Type DRUG

One 100 mg capsule taken orally (by mouth) on Days Days 1-8

Interventions

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Canagliflozin

One 100 mg capsule taken orally (by mouth) on Days Days 1-8

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No