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Evaluation of Dapagliflozin Taken Twice-daily

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dapagliflozin
dapagliflozin
dapagliflozin
metformin
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, metformin treated, inadequate control, metformin treatment alone

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Diagnosis of T2DM
  • Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
  • HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.

Exclusion Criteria:

  • Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
  • History of diabetic ketoacidosis
  • Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
  • FPG >270 mg/dL (>15.0 mmol/L)
  • BMI >45 kg/m2

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Dapagliflozin 2.5 mg twice-daily plus open-label metformin

Dapagliflozin 5.0 mg twice-daily plus open-label metformin

Dapagliflozin 10 mg once-daily plus open-label metformin

Placebo plus open-label metformin

Outcomes

Primary Outcome Measures

Adjusted Mean Change in HbA1c Levels
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.

Secondary Outcome Measures

Adjusted Percent Change in Body Weight
To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.
To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.

Full Information

First Posted
October 7, 2010
Last Updated
October 16, 2014
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01217892
Brief Title
Evaluation of Dapagliflozin Taken Twice-daily
Official Title
A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 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
No

5. Study Description

Brief Summary
This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment 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
Keywords
Type 2 diabetes, metformin treated, inadequate control, metformin treatment alone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Dapagliflozin 2.5 mg twice-daily plus open-label metformin
Arm Title
2
Arm Type
Experimental
Arm Description
Dapagliflozin 5.0 mg twice-daily plus open-label metformin
Arm Title
3
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg once-daily plus open-label metformin
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo plus open-label metformin
Intervention Type
Drug
Intervention Name(s)
dapagliflozin
Intervention Description
2.5 mg tablet, taken orally, twice daily
Intervention Type
Drug
Intervention Name(s)
dapagliflozin
Intervention Description
5 mg tablet taken orally, twice daily
Intervention Type
Drug
Intervention Name(s)
dapagliflozin
Intervention Description
10 mg tablet taken orally, once daily
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
>/= 1500 mg total daily dose, tablets taken orally, twice daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Adjusted Mean Change in HbA1c Levels
Description
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Adjusted Percent Change in Body Weight
Description
To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Time Frame
Baseline to Week 16
Title
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1
Description
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.
Time Frame
Baseline to Week 1
Title
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
Description
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Time Frame
Baseline to Week 16
Title
Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.
Description
To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.
Time Frame
Baseline to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Diagnosis of T2DM Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted. HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1. Exclusion Criteria: Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus History of diabetic ketoacidosis Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment FPG >270 mg/dL (>15.0 mmol/L) BMI >45 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamik Parikh
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Asslar
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Biberach A.d. Riss
Country
Germany
Facility Name
Research Site
City
Bosenheim
Country
Germany
Facility Name
Research Site
City
Dippoldiswalde
Country
Germany
Facility Name
Research Site
City
Falkensee
Country
Germany
Facility Name
Research Site
City
Meissen
Country
Germany
Facility Name
Research Site
City
Munchen
Country
Germany
Facility Name
Research Site
City
Neuwied
Country
Germany
Facility Name
Research Site
City
Pirna
Country
Germany
Facility Name
Research Site
City
Wahlstedt
Country
Germany
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
Debrecen
Country
Hungary
Facility Name
Research Site
City
Gyongyos
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
Mako
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
TAT
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
Country
Hungary
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Sibiu
Country
Romania
Facility Name
Research Site
City
Suceava
Country
Romania
Facility Name
Research Site
City
Banska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Dolny Kubin
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Lucenec
Country
Slovakia
Facility Name
Research Site
City
Namestovo
Country
Slovakia
Facility Name
Research Site
City
Piestany
Country
Slovakia
Facility Name
Research Site
City
Prievidza
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
Country
Slovakia
Facility Name
Research Site
City
Ruzomberok
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Verulam
State/Province
Kwa Zulu Natal
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Umkomaas
Country
South Africa
Facility Name
Research Site
City
Chur
State/Province
Graubunden
Country
Switzerland
Facility Name
Research Site
City
Basel
Country
Switzerland
Facility Name
Research Site
City
Bern
Country
Switzerland
Facility Name
Research Site
City
Geneva 14
Country
Switzerland
Facility Name
Research Site
City
Kreuzlingen
Country
Switzerland
Facility Name
Research Site
City
Lugano
Country
Switzerland
Facility Name
Research Site
City
Rorschach
Country
Switzerland
Facility Name
Research Site
City
Dnipropetrov'sk
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site
City
Vynnitsa
Country
Ukraine
Facility Name
Research Site
City
Zaporozhye
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
25200570
Citation
Schumm-Draeger PM, Burgess L, Koranyi L, Hruba V, Hamer-Maansson JE, de Bruin TW. Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial. Diabetes Obes Metab. 2015 Jan;17(1):42-51. doi: 10.1111/dom.12387. Epub 2014 Oct 16.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=296&filename=CSR-D1691C00003.pdf
Description
CSR-D1691C00003.pdf
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=296&filename=D1691C00003_Clinical_Study_Protocol_Redacted_10Jun2014.pdf
Description
D1691C00003_Clinical_Study_Protocol_Redacted

Learn more about this trial

Evaluation of Dapagliflozin Taken Twice-daily

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