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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273558
• Other study ID #: CR017719
• Secondary ID: 28431754DIA1025
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2010
• Last updated: April 19, 2013
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: April 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Canagliflozin
One 100 mg capsule taken orally (by mouth) on Days Days 1-8

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RTG values using the MMTT and the stepwise hyperglycemic clamp methods		On Days 1 and 2 (Part 1)	No
Primary	RTG values using the MMTT and the stepwise hyperglycemic clamp methods		On Days 7 and 8 (Part 2)	No
Secondary	Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure		On Days 1 and 2 (Part 1)	No
Secondary	Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure		On Days 7 and 8 (Part 2)	No
Secondary	Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure		On Days 1 and 2 (Part 1)	No
Secondary	Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure		On Days 7 and 8 (Part 2)	No

External Links

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