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Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit
  • Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment
  • C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
  • BMI ≤ 45.0 kg/m2

Exclusion Criteria:

  • Urine albumin to creatinine ratio (UACR) > 1,800 mg/g (203.4 mg/mmol/Cr)
  • Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) > 3X ULN
  • Serum Total Bilirubin > 2 mg/dL (34.2 μmol/l)
  • Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Sites / Locations

  • Va San Diego Healthcare System
  • Pennington Biomedical Research Center
  • Temple University General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapagliflozin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.

Secondary Outcome Measures

Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.

Full Information

First Posted
January 28, 2009
Last Updated
March 24, 2017
Sponsor
AstraZeneca
Collaborators
Astra Zeneca, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00831779
Brief Title
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Astra Zeneca, Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
BMS-512148
Intervention Description
Tablets, Oral, 5 mg, once daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, Once daily, 12 weeks
Primary Outcome Measure Information:
Title
Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])
Description
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.
Time Frame
From Baseline to Week 12
Secondary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])
Description
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.
Time Frame
From Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment C-peptide ≥ 1.0 ng/ml (0.34 nmol/l) BMI ≤ 45.0 kg/m2 Exclusion Criteria: Urine albumin to creatinine ratio (UACR) > 1,800 mg/g (203.4 mg/mmol/Cr) Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN) Alanine aminotransferase (ALT) > 3X ULN Serum Total Bilirubin > 2 mg/dL (34.2 μmol/l) Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Va San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Temple University General Clinical Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Links:
URL
http://online.liebertpub.com/doi/full/10.1089/dia.2013.0167
Description
Publication

Learn more about this trial

Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

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