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

NCT00831779 | Completed Phase 2 Results

• 1 other identifier: MB102-045
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to Week 12

Secondary Outcomes (1)

• Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])

  From Baseline to Week 12

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dapagliflozin DRUG

Tablets, Oral, 5 mg, once daily, 12 weeks

Also known as: BMS-512148

Dapagliflozin

Placebo DRUG

Tablets, Oral, 0 mg, Once daily, 12 weeks

Placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Astra Zeneca, Bristol-Myers Squibb: collaborator

Study Sites (3)

Va San Diego Healthcare System

San Diego, California, 92161, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Temple University General Clinical Research Center

Philadelphia, Pennsylvania, 19140, United States

Location

Related Links

• Publication

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Anna Maria Langkilde
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 29, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 24, 2017
• Results First Posted: March 1, 2017

Record last verified: 2017-03

Locations

US (3)