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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Canagliflozin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Canagliflozin, Renal threshold for glucose, Pharmacodynamics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Part 1: no Intervention

Part 2: canagliflozin

Arm Description

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

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

Outcomes

Primary Outcome Measures

RTG values using the MMTT and the stepwise hyperglycemic clamp methods

Secondary Outcome Measures

Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure

Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure

Full Information

NCT ID

NCT01273558

First Posted

December 10, 2010

Last Updated

April 19, 2013

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01273558

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Canagliflozin, Renal threshold for glucose, Pharmacodynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: no Intervention

Arm Type

No Intervention

Arm Description

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

Arm Title

Part 2: canagliflozin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Canagliflozin

Intervention Description

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

Primary Outcome Measure Information:

Title

RTG values using the MMTT and the stepwise hyperglycemic clamp methods

Time Frame

On Days 1 and 2 (Part 1)

Title

RTG values using the MMTT and the stepwise hyperglycemic clamp methods

Time Frame

On Days 7 and 8 (Part 2)

Secondary Outcome Measure Information:

Title

Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure

Time Frame

On Days 1 and 2 (Part 1)

Title

Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure

Time Frame

On Days 7 and 8 (Part 2)

Title

Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure

Time Frame

On Days 1 and 2 (Part 1)

Title

Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure

Time Frame

On Days 7 and 8 (Part 2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

City

Neuss

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

23585665

Citation

Polidori D, Sha S, Ghosh A, Plum-Morschel L, Heise T, Rothenberg P. Validation of a novel method for determining the renal threshold for glucose excretion in untreated and canagliflozin-treated subjects with type 2 diabetes mellitus. J Clin Endocrinol Metab. 2013 May;98(5):E867-71. doi: 10.1210/jc.2012-4205. Epub 2013 Apr 12.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=877&filename=CR017719_CSR.pdf

Description

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

Learn more about this trial

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

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