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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673231
• Other study ID #: D1690C00006
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2008
• Last updated: September 25, 2013
• Start date: April 2008
• Est. completion date: January 2011

Study information

• Verified date: September 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBulgaria: Ministry of HealthCanada: Health CanadaFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Romania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1240
• Est. completion date: January 2011
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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)
• Dapagliflozin
Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
• Dapagliflozin
Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
• Placebo
Placebo
• Dapagliflozin
tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
• 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

Locations

Country	Name	City	State
Austria	Research Site	Salzburg
Austria	Research Site	Wien
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Langley	British Columbia
Canada	Research Site	London	Ontario
Canada	Research Site	Longueuil	Quebec
Canada	Research Site	Mirabel	Quebec
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Thornhill	Ontario
Canada	Research Site	Winnipeg	Manitoba
Finland	Research Site	Helsinki
Finland	Research Site	Joensuu
Finland	Research Site	Jyvaskyla
Finland	Research Site	Kuopio
Finland	Research Site	Lahti
Finland	Research Site	Oulu
Finland	Research Site	Seinajoki
Finland	Research Site	Turku
Germany	Research Site	Bad Oeynhausen
Germany	Research Site	Dortmund
Germany	Research Site	Dresden
Germany	Research Site	Essen
Germany	Research Site	Frankfurt
Germany	Research Site	Magdeburg
Germany	Research Site	Münster
Germany	Research Site	Riesa
Germany	Research Site	Wolmirstedt
Hungary	Research Site	Csongrad
Hungary	Research Site	Esztergom
Hungary	Research Site	Gyor
Hungary	Research Site	Kaposvar
Hungary	Research Site	Kecskemet
Hungary	Research Site	Komarom
Hungary	Research Site	Miskolc
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Veszprem
Netherlands	Research Site	Amersfoort
Netherlands	Research Site	Den Helder
Netherlands	Research Site	Leiden
Netherlands	Research Site	Rotterdam
Romania	Research Site	Brasov
Romania	Research Site	Bucuresti
Romania	Research Site	Tg Mures	Mures
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhnii Novgorod
Russian Federation	Research Site	Saint- Petersburg
Russian Federation	Research Site	St Petersburg
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	St.-petersburg
Russian Federation	Research Site	St.petersburg
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Dolny Kubin
Slovakia	Research Site	Kosice
Slovakia	Research Site	Levice
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Povazska Bystrica
Slovakia	Research Site	Presov
Spain	Research Site	Alicante	Comunidad Valenciana
Spain	Research Site	Madrid	Comunidad de Madrid
Spain	Research Site	Sabadell (barcelona)	Cataluna
Spain	Research Site	Sevilla	Andalucia
United Kingdom	Research Site	Ashford
United Kingdom	Research Site	Aylesbury	Bucks
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	Reading
United Kingdom	Research Site	Reading	Berks
United Kingdom	Research Site	Swansea
United States	Research Site	Chicago	Illinois
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Fresno	California
United States	Research Site	Greenbrae	California
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Norfolk	Virginia
United States	Research Site	Omaha	Nebraska
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Richmond	Virginia
United States	Research Site	Roswell	Georgia
United States	Research Site	Springfield	Illinois
United States	Research Site	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Canada,  Finland,  Germany,  Hungary,  Netherlands,  Romania,  Russian Federation,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Participants With Lack of Glycemic Control	Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets	Baseline to Week 24	No
Primary	Adjusted Mean Change in HbA1c Levels	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.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Body Weight	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.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Calculated Mean Daily Insulin Dose	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.	Baseline to Week 24	No
Secondary	Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction	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.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Fasting Plasma Glucose (FPG)	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.	Baseline to Week 24	No