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

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Dapagliflozin Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

HbA1c, mean change from baseline - 2.5 mg, 5 mg and 10 mg Dapagliflozin compared to Placebo as add-on Therapy to Insulin in Improving Glycaemic Control. [ Time Frame: from baseline to 24 week ] [ Designated as safety issue: No ]
Participants With Type 2 Diabetes Who Have Inadequate Glycaemic Control

Secondary Outcome Measures:

Body weight, mean change from baseline - 2.5 mg, 5 mg and 10 mg Dapagliflozin compared to Placebo as add-on Therapy to Insulin in Improving Glycaemic Control. [ Time Frame: from baseline to 24 week ] [ Designated as safety issue: No ]
Calculated Mean Daily Insulin Dose, mean change from baseline - 2.5 mg, 5 mg and 10 mg Dapagliflozin compared to Placebo as add-on Therapy to Insulin in Improving Glycaemic Control. [ Time Frame: from baseline to 24 week ] [ Designated as safety issue: No ]
Percentage of Participants with calculated mean daily insulin dose reduction >_ 10% - 2.5 mg, 5 mg and 10 mg Dapagliflozin compared to Placebo as add-on Therapy to Insulin in Improving Glycaemic Control. [ Time Frame: from baseline to 24 week ] [ Designated as safety issue: No ]
Fasting Plasma Glucose (FPG), mean change from baseline - 2.5 mg, 5 mg and 10 mg Dapagliflozin compared to Placebo as add-on Therapy to Insulin in Improving Glycaemic Control. [ Time Frame: from baseline to 24 week ] [ Designated as safety issue: No ]

Enrollment:	1240
Study Start Date:	April 2008
Study Completion Date:	January 2011
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 2.5mg	Drug: Dapagliflozin tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) Drug: Dapagliflozin tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
Experimental: 2 5mg	Drug: Dapagliflozin Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Experimental: 3 10mg	Drug: Dapagliflozin Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) Drug: Dapagliflozin tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
Placebo Comparator: 4	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673231

Show 96 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Principal Investigator:

John Wilding, MD

Clinical Sciences CentreUniversity Hospital AintreeLongmoor LaneLiverpool, UK

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Studiengruppe Dapagliflozin 006. [Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S27-38. doi: 10.1055/s-0032-1305284. Epub 2013 Mar 25. German.

Wilding JP, Woo V, Soler NG, Pahor A, Sugg J, Rohwedder K, Parikh S; Dapagliflozin 006 Study Group. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):405-15.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00673231 History of Changes
Other Study ID Numbers:	D1690C00006
Study First Received:	May 6, 2008
Last Updated:	May 10, 2012
Health Authority:	Austria: Agency for Health and Food Safety Bulgaria: Ministry of Health Canada: Health Canada Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Dapagliflozin
efficacy
safety

add on to insulin
Oral AntiDiabetic
Type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013