NCT01128153

Brief Summary

The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
6 countries

33 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

First Submitted

Initial submission to the registry

May 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 3, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

May 20, 2010

Results QC Date

June 11, 2012

Last Update Submit

August 7, 2012

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesInadequate Glycaemic ControlSaxagliptinMetforminSulfonylureaTriple Oral Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)

    Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model

    From Baseline to Week 24 weeks

Secondary Outcomes (5)

  • Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]

    From Baseline to Week 24

  • Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]

    From Baseline to Week 24

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]

    From Baseline to Week 24

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]

    From Baseline to Week 24

  • Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)

    From Baseline to Week 24

Study Arms (2)

Saxagliptin 5 mg once daily

EXPERIMENTAL
Drug: Saxagliptin

Placebo once daily

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SaxagliptinDRUG

5 mg tablet once daily for 24 weeks to be taken orally

Also known as: Onglyza
Saxagliptin 5 mg once daily
PlaceboDRUG

tablet once daily for 24 weeks to be taken orally

Placebo once daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written Informed Consent
  • Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c \> or = 7% and \< or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
  • BMI \< or = 40 kg/m2

You may not qualify if:

  • Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with \> 10% weight loss in 3 months prior to entry, or other signs and symptoms
  • History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
  • Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
  • Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
  • Estimated CrCl \< 60 ml/min at Visit 2
  • CHF (NYHA class III or IV) and/or LVEF \<40%
  • Active liver disease and/or significant abnormal liver function defined as AST and/or ALT \> 3 x ULN and/or bilirubin \> 2.0 mg/dL at Visit 2.
  • Creatine kinase \> or = 10 x ULN at Visit 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Research Site

Broadmeadow, New South Wales, Australia

Location

Research Site

Wollongong, New South Wales, Australia

Location

Research Site

Daw Park, South Australia, Australia

Location

Research Site

Elizabeth Vale, South Australia, Australia

Location

Research Site

Melbourne, Victoria, Australia

Location

Research Site

Camperdown, Australia

Location

Research Site

Herston, Australia

Location

Research Site

St. John's, Newfoundland and Labrador, Canada

Location

Research Site

Sydney Mines, Nova Scotia, Canada

Location

Research Site

Thornhill, Ontario, Canada

Location

Research Site

Kensington, Prince Edward Island, Canada

Location

Research Site

Karnāl, Haryana, India

Location

Research Site

Bangalore, Karnataka, India

Location

Research Site

Indore, Madhya Pradesh, India

Location

Research Site

Pune, Maharashtra, India

Location

Research Site

Coimbatore, Tamil Nadu, India

Location

Research Site

Wŏnju, Gangwon-do, South Korea

Location

Research Site

Goyang, Kyounggi-do, South Korea

Location

Research Site

Daegu, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Bangkok, Thailand

Location

Research Site

Reading, Berks, United Kingdom

Location

Research Site

Ely, Cambridgeshire, United Kingdom

Location

Research Site

Whitstable, Kent, United Kingdom

Location

Research Site

Westbury, Wiltshire, United Kingdom

Location

Research Site

Ashford, United Kingdom

Location

Research Site

Belfast, United Kingdom

Location

Research Site

Blackpool, United Kingdom

Location

Research Site

Chesterfield, United Kingdom

Location

Research Site

Coventry, United Kingdom

Location

Research Site

Glasgow, United Kingdom

Location

Research Site

Peterborough, United Kingdom

Location

Research Site

Wellingborough, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com
+44 1625 518062

Study Officials

  • Jayanti Visvanthan, MD

    AstraZeneca

    STUDY CHAIR

  • Simon Fisher, MD

    AstraZeneca

    STUDY CHAIR

  • Vinod Mattoo, MD

    Bristol-Myers Squibb

    STUDY CHAIR

  • Robert Moses, MBBS

    Sydney Diabetes Centre

    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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 21, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 10, 2012

Results First Posted

August 3, 2012

Record last verified: 2012-08

Locations

TH(1)IN(5)CA(4)GB(12)KR(4)AU(7)