Clinical trial NCT00855166: Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Dapagliflozin
Metformin
Type 2 diabetes
body weight
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-03-04
Enrollment: 182
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adjusted Mean Change in Total Body Weight
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Adjusted Mean Change in Waist Circumference
timeFrame: Baseline to Week 24
measure: Adjusted Mean Change in Body Fat Mass
timeFrame: Baseline to Week 24
measure: Proportion of Participants With Body Weight Decrease ≥5%
timeFrame: Baseline to Week 24
Other outcomes:
measure: Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)
timeFrame: Baseline to Week 102
measure: Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck
timeFrame: Baseline to Week 102
measure: Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip
timeFrame: Baseline to Week 102
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Beroun
country: Czech Republic
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Semily
country: Czech Republic
facility: Research Site
city: Slany
country: Czech Republic
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Csongrad
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: TAT
country: Hungary
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Jarfalla
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden
name: Jan Bolinder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
citation: Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.
citation: Ljunggren O, Bolinder J, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab. 2012 Nov;14(11):990-9. doi: 10.1111/j.1463-1326.2012.01630.x. Epub 2012 Jun 29.