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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT01273558

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Canagliflozin	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Part 1: no Intervention In Part 1 of the study, patients will not receive any study drug.
Experimental: Part 2: canagliflozin In Part 2 of the study, patients will receive canagliflozin once daily on Days 1 through 8.	Drug: Canagliflozin One 100 mg capsule taken orally (by mouth) on Days Days 1-8

Arm

Intervention/Treatment

No Intervention: Part 1: no Intervention

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

Experimental: Part 2: canagliflozin

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

Drug: Canagliflozin

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

Outcome Measures

Primary Outcome Measures

RTG values using the MMTT and the stepwise hyperglycemic clamp methods [On Days 1 and 2 (Part 1)]
RTG values using the MMTT and the stepwise hyperglycemic clamp methods [On Days 7 and 8 (Part 2)]

Secondary Outcome Measures

Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure [On Days 1 and 2 (Part 1)]
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 1 and 2 (Part 1)]
Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure [On Days 7 and 8 (Part 2)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Neuss		Germany

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.