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

An Open-Label Study to Compare Two Methods for Determining the Renal Threshold for Glucose in Subjects With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273558

Enrollment

Registered

2011-01-10

Start date

2011-01-31

Completion date

2011-07-31

Last updated

2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Canagliflozin, Renal threshold for glucose, Pharmacodynamics

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.

Interventions

DRUGCanagliflozin

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

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
RTG values using the MMTT and the stepwise hyperglycemic clamp methods	On Days 1 and 2 (Part 1)

Secondary

Measure	Time frame
Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure	On Days 1 and 2 (Part 1)
Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure	On Days 1 and 2 (Part 1)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026