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

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ClinicalTrials.gov Identifier: NCT01273558
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : January 2011
Actual Study Completion Date : July 2011

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. RTG values using the MMTT and the stepwise hyperglycemic clamp methods [ Time Frame: On Days 1 and 2 (Part 1) ]
  2. RTG values using the MMTT and the stepwise hyperglycemic clamp methods [ Time Frame: On Days 7 and 8 (Part 2) ]

Secondary Outcome Measures :
  1. Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure [ Time Frame: On Days 1 and 2 (Part 1) ]
  2. Plasma glucose (PG) concentration during the MMT and the hyperglycemic clamp procedure [ Time Frame: On Days 7 and 8 (Part 2) ]
  3. Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure [ Time Frame: On Days 1 and 2 (Part 1) ]
  4. Rate of Urinary glucose excretion (UGE) during the MMTT and the hyperglycemic clamp procedure [ Time Frame: On Days 7 and 8 (Part 2) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273558


Locations
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Germany
Neuss, Germany
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01273558    
Other Study ID Numbers: CR017719
28431754DIA1025 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Canagliflozin
Renal threshold for glucose
Pharmacodynamics
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs