Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dapagliflozin; Drug: Placebo

• Registration Number: NCT00673231
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2009-05
• Study Completion: 2011-01
• Results First Submitted: 2013-01-21
• Results First Submitted QC: 2013-07-19
• Results First Posted: 2013-08-23
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-25
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1240

Inclusion Criteria

• 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

Exclusion Criteria

• Type 1 Diabetes
• Treatment with more than two additional oral antidiabetic drugs
• Moderate and severe renal (kidney) failure or dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Dapagliflozin	2.5mg
2	Dapagliflozin	5mg
4	Placebo	-
3	Dapagliflozin	10mg

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change in HbA1c Levels	Baseline to Week 24	To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction	Baseline to Week 24	To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction \>= 10%) as compared to placebo added to insulin treatment.
Adjusted Mean Change in Body Weight	Baseline to Week 24	To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.
Adjusted Mean Change in Calculated Mean Daily Insulin Dose	Baseline to Week 24	To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.
Adjusted Mean Change in Fasting Plasma Glucose (FPG)	Baseline to Week 24	To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Swansea, United Kingdom