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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin
Metformin
Sitagliptin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Dapagliflozin, Metformin, Type 2 diabetes, body weight

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Dapagliflozin 10 mg plus Metformin

Placebo plus Metformin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 3, 2009
Last Updated
August 9, 2013
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00855166
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Dapagliflozin, Metformin, Type 2 diabetes, body weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg plus Metformin
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo plus Metformin
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Tablet oral 10 mg total daily dose once daily 102 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Description
Tablet oral 100 mg total daily dose once daily rescue medication
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks
Primary Outcome Measure Information:
Title
Adjusted Mean Change in Total Body Weight
Description
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.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Adjusted Mean Change in Waist Circumference
Description
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.
Time Frame
Baseline to Week 24
Title
Adjusted Mean Change in Body Fat Mass
Description
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.
Time Frame
Baseline to Week 24
Title
Proportion of Participants With Body Weight Decrease ≥5%
Description
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.
Time Frame
Baseline to Week 24
Other Pre-specified Outcome Measures:
Title
Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)
Description
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.
Time Frame
Baseline to Week 102
Title
Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Description
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.
Time Frame
Baseline to Week 102
Title
Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip
Description
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.
Time Frame
Baseline to Week 102

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Bolinder, MD, PhD
Organizational Affiliation
Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Blagoevgrad
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Beroun
Country
Czech Republic
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Praha
Country
Czech Republic
Facility Name
Research Site
City
Semily
Country
Czech Republic
Facility Name
Research Site
City
Slany
Country
Czech Republic
Facility Name
Research Site
City
Balatonfured
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Csongrad
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
TAT
Country
Hungary
Facility Name
Research Site
City
Elblag
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Jarfalla
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26894924
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.
Results Reference
derived
PubMed Identifier
23906445
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.
Results Reference
derived
PubMed Identifier
22651373
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.
Results Reference
derived

Learn more about this trial

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

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