Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— DEPICT 1  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268214
• Other study ID #: MB102-229
• Secondary ID: 2013-004674-97D1
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2014
• Est. completion date: August 25, 2017

Study information

• Verified date: August 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Description:

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 833
• Est. completion date: August 25, 2017
• Est. primary completion date: January 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Type 1 Diabetes mellitus (T1DM)

• Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)

• Insulin use for at least 12 months per patient reported or medical records

• Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening

• Subjects must be on a total insulin dose of = 0.3 U/kg/day for at least 3 months prior to screening

• If on MDI insulin administration, subject must be on = 3x injections per day

• Screening Visit: Central laboratory HbA1c = 7.7% and = 11.0%

• Body mass index (BMI) = 18.5 kg/m2

Exclusion Criteria:

• History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity

• Taking metformin and/or thiazolidinediones within 2 months prior to screening

• Taking any antidiabetic medication (other than insulin), within 1 month prior to screening

• Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration

• History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening

• History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening

• Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening

• History of Addison's disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablets
• Placebo for dapagliflozin
Tablets

Locations

Country	Name	City	State
Australia	Research Site	Concord
Australia	Research Site	Daw Park
Australia	Research Site	Fitzroy
Australia	Research Site	Heidelberg West
Australia	Research Site	Newcastle
Australia	Research Site	Southport
Australia	Research Site	Wollongong
Austria	Research Site	Innsbruck
Austria	Research Site	Saint Stefan/Stainz
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Bonheiden
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Canada	Research Site	Laval	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Winnipeg	Manitoba
Denmark	Research Site	Arhus C
Denmark	Research Site	Esbjerg
Denmark	Research Site	Odense
Denmark	Research Site	Randers NØ
Finland	Research Site	Helsinki
Finland	Research Site	Jyvaskyla
Finland	Research Site	Kuopio
Finland	Research Site	Oulu
Finland	Research Site	Tampere
France	Research Site	Besançon Cedex
France	Research Site	Corbeil-Essonnes
France	Research Site	Dijon
France	Research Site	SAINT HERBLAIN Cedex
France	Research Site	Vandoeuvre les Nancy
Germany	Research Site	Aschaffenburg
Germany	Research Site	Aßlar
Germany	Research Site	Bad Oeynhausen
Germany	Research Site	Falkensee
Germany	Research Site	Munich
Germany	Research Site	Munster
Germany	Research Site	Neuwied
Germany	Research Site	Oldenburg
Germany	Research Site	Pohlheim
Germany	Research Site	Schweinfurt
Germany	Research Site	Sulzbach
Germany	Research Site	Witten
Hungary	Research Site	Baja
Hungary	Research Site	Balatonfured
Hungary	Research Site	Budapest
Hungary	Research Site	Létavértes
Hungary	Research Site	Szeged
Hungary	Research Site	Zalaegerszeg
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Safed
Israel	Research Site	Tel-Aviv
Israel	Research Site	Tikva
Italy	Research Site	Firenze
Italy	Research Site	Milano
Italy	Research Site	Padowa
Italy	Research Site	Palermo
Italy	Research Site	Ravenna
Italy	Research Site	Sesto San Giovanni
Italy	Research Site	Siena
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Chihuahua
Mexico	Research Site	Cuernavaca
Mexico	Research Site	Guadalajara
Mexico	Research Site	Merida
Mexico	Research Site	Mexico
Mexico	Research Site	Monterrey
Mexico	Research Site	Monterrey
Mexico	Research Site	Torreon
Mexico	Research Site	Zapopan
Mexico	Research Site	Zapopan, Jalisco
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Dolj
Romania	Research Site	Galati
Romania	Research Site	Iasi
Romania	Research Site	Timisoara
Spain	Research Site	A Coruña
Spain	Research Site	Almeria
Spain	Research Site	Barcelona
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Sweden	Research Site	Göteborg
Sweden	Research Site	Karlstad
Sweden	Research Site	Lund
Sweden	Research Site	Uppsala
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Chesterfield
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Welwyn Garden City
United States	Research Site	Albany	New York
United States	Research Site	Amarillo	Texas
United States	Research Site	Asheville	North Carolina
United States	Research Site	Aurora	Colorado
United States	Research Site	Buffalo	New York
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Chesterfield	Missouri
United States	Research Site	Cooper City	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	Des Moines	Iowa
United States	Research Site	Encino	California
United States	Research Site	Greenville	North Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Hyattsville	Maryland
United States	Research Site	Idaho Falls	Idaho
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Kingsport	Tennessee
United States	Research Site	La Mesa	California
United States	Research Site	Langhorne	Pennsylvania
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Louisville	Kentucky
United States	Research Site	Miami	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Morehead City	North Carolina
United States	Research Site	Nashville	Tennessee
United States	Research Site	Olympia	Washington
United States	Research Site	Port Orange	Florida
United States	Research Site	Portland	Maine
United States	Research Site	Rockville	Maryland
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Diego	California
United States	Research Site	Tarzana	California
United States	Research Site	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Mexico,  Romania,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Change in HbA1c From Baseline at Week 24	Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).	From Baseline to Week 24
Secondary	Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24	Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])	From Baseline to Week 24
Secondary	Adjusted Mean Percent Change in Body Weight From Baseline at Week 24	Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM])	From Baseline to Week 24
Secondary	Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24	Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM])	From Baseline to Week 24
Secondary	Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24	Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model[RMM])	From Baseline to Week 24
Secondary	Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24	Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model[RMM])	From Baseline to Week 24
Secondary	Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events	Subjects with HbA1c reduction from baseline to week 24 (LOCF) >= 0.5% and without severe hypoglycemia events	From Baseline to Week 24

External Links

•   MB102229_CSP