Completed

Dapagliflozin and Insulin Therapy for Type 2 Diabetes Control

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Study Aim

This study aims to evaluate the effectiveness of different doses of Dapagliflozin, when used alongside insulin therapy, in improving blood sugar control in individuals with Type 2 Diabetes who have inadequate control with insulin alone, as measured by changes in HbA1c levels over a 24-week period.

What is being tested

Dapagliflozin

+ Placebo

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 80 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: April 2008
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, 2008

Actual date on which the first participant was enrolled.

This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

Official TitleA 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes With Inadequate Glycaemic Control on Insulin
NCT00673231
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

1240 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 18 to 80 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

2 inclusion criteria required to participate
Type 2 Diabetes
Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs
3 exclusion criteria prevent from participating
Type 1 Diabetes
Treatment with more than two additional oral antidiabetic drugs
Moderate and severe renal (kidney) failure or dysfunction

Study Plan

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

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
2.5mg

Group II

Experimental
5mg

Group III

Experimental
10mg

Group IV

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 92 locations

Suspended

Research Site

Fresno, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Greenbrae, United States
Suspended

Research Site

Roswell, United States
Suspended

Research Site

Chicago, United States
Completed92 Study Centers