NCT00855166

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3 type-2-diabetes-mellitus

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 14, 2013

Completed
Last Updated

October 14, 2013

Status Verified

August 1, 2013

Enrollment Period

1.3 years

First QC Date

March 3, 2009

Results QC Date

January 21, 2013

Last Update Submit

August 9, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

DapagliflozinMetforminType 2 diabetesbody weight

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Adjusted Mean Change in Waist Circumference

    Baseline to Week 24

  • Adjusted Mean Change in Body Fat Mass

    Baseline to Week 24

  • Proportion of Participants With Body Weight Decrease ≥5%

    Baseline to Week 24

Other Outcomes (3)

  • Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)

    Baseline to Week 102

  • Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck

    Baseline to Week 102

  • Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip

    Baseline to Week 102

Study Arms (2)

A

EXPERIMENTAL

Dapagliflozin 10 mg plus Metformin

Drug: DapagliflozinDrug: MetforminDrug: Sitagliptin

B

PLACEBO COMPARATOR

Placebo plus Metformin

Drug: MetforminDrug: SitagliptinDrug: Placebo

Interventions

DapagliflozinDRUG

Tablet oral 10 mg total daily dose once daily 102 weeks

A
MetforminDRUG

Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks

AB
SitagliptinDRUG

Tablet oral 100 mg total daily dose once daily rescue medication

AB
PlaceboDRUG

Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

B

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Type 1 Diabetes
  • Body weight change \>5% within 3 months prior to enrolment
  • Renal and liver impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Research Site

Blagoevgrad, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Beroun, Czechia

Location

Research Site

Brno, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Semily, Czechia

Location

Research Site

Slaný, Czechia

Location

Research Site

Balatonfüred, Hungary

Location

Research Site

Budapest, Hungary

Location

Research Site

Csongrád, Hungary

Location

Research Site

Kecskemét, Hungary

Location

Research Site

Tát, Hungary

Location

Research Site

Elblag, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Torun, Poland

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Jarfalla, Sweden

Location

Research Site

Lund, Sweden

Location

Research Site

Malmo, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Uppsala, Sweden

Location

Related Publications (4)

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PMID: 38770818DERIVED

  • 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.

    PMID: 26894924DERIVED

  • 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.

    PMID: 23906445DERIVED

  • 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.

    PMID: 22651373DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Body Weight

Interventions

dapagliflozinMetforminSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Limitations and Caveats

For participants who did not complete 24 weeks, last observation carried forward (LOCF) was used.

Results Point of Contact

Title
Eva Johnsson
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Jan Bolinder, MD, PhD

    Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2011

Last Updated

October 14, 2013

Results First Posted

October 14, 2013

Record last verified: 2013-08

Locations

BU(2)HU(5)CZ(5)PL(3)SE(6)