Completed

Dapagliflozin's Impact on Insulin Resistance and Secretion in Type 2 Diabetes

Study Aim

This study aims to evaluate how Dapagliflozin affects insulin resistance and secretion in individuals with Type 2 Diabetes, specifically by measuring the percent change in insulin sensitivity from the start of the study to week 12.

What is being tested

Dapagliflozin

+ Placebo

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 35 to 70 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: April 2009

See protocol details

Summary

Principal SponsorAstraZeneca

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2009

Actual date on which the first participant was enrolled.

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

Official TitleA 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

NCT00831779

Principal SponsorAstraZeneca

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

116 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate

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

6 exclusion criteria prevent from participating

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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Va San Diego Healthcare System

San Diego, United StatesOpen Va San Diego Healthcare System in Google Maps

Suspended

Pennington Biomedical Research Center

Baton Rouge, United States

Suspended

Temple University General Clinical Research Center

Philadelphia, United States

Completed3 Study Centers