Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855166
• Other study ID #: D1690C00012
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2009
• Last updated: August 9, 2013
• Start date: February 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: Ministry of HealthSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Ongoing treatment with metformin on a stable dose of =1500 mg/day for at least 12 weeks prior to enrolment

• Inadequate glycemic control, defined as HbA1c =6.5% and =8.5%

• =30 years for males

• =55 years for females

Exclusion Criteria:

• Type 1 Diabetes

• Body weight change >5% within 3 months prior to enrolment

• Renal and liver impairment

Study Design

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablet oral 10 mg total daily dose once daily 102 weeks
• Metformin
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
• Sitagliptin
Tablet oral 100 mg total daily dose once daily rescue medication
• Placebo
Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

Locations

Country	Name	City	State
Bulgaria	Research Site	Blagoevgrad
Bulgaria	Research Site	Sofia
Czech Republic	Research Site	Beroun
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Praha
Czech Republic	Research Site	Semily
Czech Republic	Research Site	Slany
Hungary	Research Site	Balatonfured
Hungary	Research Site	Budapest
Hungary	Research Site	Csongrad
Hungary	Research Site	Kecskemet
Hungary	Research Site	TAT
Poland	Research Site	Elblag
Poland	Research Site	Krakow
Poland	Research Site	Torun
Sweden	Research Site	Goteborg
Sweden	Research Site	Jarfalla
Sweden	Research Site	Lund
Sweden	Research Site	Malmo
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Hungary,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)	To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.	Baseline to Week 102	Yes
Other	Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck	To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.	Baseline to Week 102	Yes
Other	Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip	To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.	Baseline to Week 102	Yes
Primary	Adjusted Mean Change in Total Body Weight	To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Waist Circumference	To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.	Baseline to Week 24	No
Secondary	Adjusted Mean Change in Body Fat Mass	To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.	Baseline to Week 24	No
Secondary	Proportion of Participants With Body Weight Decrease =5%	To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease =5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.	Baseline to Week 24	No