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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01273558
First received: December 10, 2010
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Canagliflozin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • RTG values using the MMTT and the stepwise hyperglycemic clamp methods [ Time Frame: On Days 1 and 2 (Part 1) ] [ Designated as safety issue: No ]
  • RTG values using the MMTT and the stepwise hyperglycemic clamp methods [ Time Frame: On Days 7 and 8 (Part 2) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure [ Time Frame: On Days 1 and 2 (Part 1) ] [ Designated as safety issue: No ]
  • Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure [ Time Frame: On Days 7 and 8 (Part 2) ] [ Designated as safety issue: No ]
  • Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure [ Time Frame: On Days 1 and 2 (Part 1) ] [ Designated as safety issue: No ]
  • Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure [ Time Frame: On Days 7 and 8 (Part 2) ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2011
Study Completion Date: July 2011
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273558

Locations
Germany
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.
  More Information

Additional Information:
An Open-Label Study to Compare Two Methods for Determining the Renal Threshold for Glucose in Subjects With Type 2 Diabetes Mellitus  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01273558     History of Changes
Other Study ID Numbers: CR017719, 28431754DIA1025
Study First Received: December 10, 2010
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Canagliflozin
Renal threshold for glucose
Pharmacodynamics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013