Completed

Dapagliflozin's Safety and Efficacy in Type 2 Diabetes Control on Sitagliptin+/-Metformin

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Study Aim

This study aims to evaluate the safety and effectiveness of Dapagliflozin in controlling Type 2 Diabetes in individuals who are currently inadequately controlled by Sitagliptin alone or in combination with Metformin, by comparing the change in HbA1c levels after 24 weeks of treatment.

What is being tested

Dapagliflozin

+ Placebo

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 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: October 1, 2009

Actual date on which the first participant was enrolled.

This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.

Official TitleA 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin
NCT00984867
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

833 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.

Over 18 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

3 inclusion criteria required to participate
Patients with type 2 diabetes
Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
Patients will be screened by a blood test and only those who need additional therapy can be enrolled
3 exclusion criteria prevent from participating
Patients with type 1 diabetes
Patients with very poorly controlled diabetes
Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study

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

Active Comparator
Dapagliflozin 10 mg tablet

Group II

Placebo
Matching placebo tablet

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 88 locations

Suspended

Research Site

Huntsville, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Ozark, United States
Suspended

Research Site

Anaheim, United States
Suspended

Research Site

Chula Vista, United States
Completed88 Study Centers