18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

March 5, 2010 updated by: AstraZeneca

18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

822

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Caba, Argentina
        • Research Site
      • Capital Federal, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
    • Buenos Aires
      • Lanus, Buenos Aires, Argentina
        • Research Site
      • Mar Del Plata, Buenos Aires, Argentina
        • Research Site
  • Belgium
      • Aalst, Belgium
        • Research Site
      • Bonheiden, Belgium
        • Research Site
      • Brugge, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Gozee, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Saint-medard, Belgium
        • Research Site
      • Sint-gillis-waas, Belgium
        • Research Site
      • Tessenderlo, Belgium
        • Research Site
      • Thuillies, Belgium
        • Research Site
  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Arhus, Denmark
        • Research Site
      • Christiansfeld, Denmark
        • Research Site
      • Farso, Denmark
        • Research Site
      • Gentofte, Denmark
        • Research Site
      • Hobro, Denmark
        • Research Site
      • Kolding, Denmark
        • Research Site
      • Rodovre, Denmark
        • Research Site
      • Viborg, Denmark
        • Research Site
  • France
      • Angers, France
        • Research Site
      • Chateau Gontier, France
        • Research Site
      • Corbeil Essonnes, France
        • Research Site
      • La Seyne Sur Mer, France
        • Research Site
      • Laval, France
        • Research Site
      • Le Lavandou, France
        • Research Site
      • Montrevault, France
        • Research Site
      • Saint Cyr, France
        • Research Site
      • Tierce, France
        • Research Site
      • Toulon, France
        • Research Site
      • Witry Les Reims, France
        • Research Site
  • Italy
    • BG
      • Bergamo, BG, Italy
        • Research Site
    • FG
      • Foggia, FG, Italy
        • Research Site
    • GE
      • Chiavari, GE, Italy
        • Research Site
      • Genova, GE, Italy
        • Research Site
    • MI
      • Rozzano, MI, Italy
        • Research Site
    • OT
      • Olbia, OT, Italy
        • Research Site
    • PD
      • Padova, PD, Italy
        • Research Site
    • PN
      • Pordenone, PN, Italy
        • Research Site
    • SA
      • Mercato San Severino, SA, Italy
        • Research Site
    • SI
      • Siena, SI, Italy
        • Research Site
  • Mexico
      • Monterrey, Mexico
        • Research Site
    • D.f.
      • Mexico, D.f., Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
  • Norway
      • Alesund, Norway
        • Research Site
      • Elverum, Norway
        • Research Site
      • Halden, Norway
        • Research Site
      • Hamar, Norway
        • Research Site
      • Lierskogen, Norway
        • Research Site
      • Lillehammer, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Sandvika, Norway
        • Research Site
      • Strommen, Norway
        • Research Site
      • Svelvik, Norway
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Kwa Zulu Natal, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
    • Gauteng
      • Benoni, Gauteng, South Africa
        • Research Site
      • Johannesburg, Gauteng, South Africa
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Research Site
  • Sweden
      • Boras, Sweden
        • Research Site
      • Degeberga, Sweden
        • Research Site
      • Finspang, Sweden
        • Research Site
      • Goteborg, Sweden
        • Research Site
      • Jonkoping, Sweden
        • Research Site
      • Odeshog, Sweden
        • Research Site
      • Orebro, Sweden
        • Research Site
      • Pitea, Sweden
        • Research Site
      • Rattvik, Sweden
        • Research Site
      • Skanor, Sweden
        • Research Site
      • Timra, Sweden
        • Research Site
      • Trollhattan, Sweden
        • Research Site
      • Uddevalla, Sweden
        • Research Site
      • Umea, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks

Exclusion Criteria:

  • Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
  • Insulin therapy within one year
  • Previous treatment with DPP-4 inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
saxagliptin add-on to metformin
Drug: saxagliptin
tablet, per oral, once daily
Other Names:
  • Onglyza
Active Comparator: 2
sitagliptin add-on to metformin
Drug: sitagliptin
capsule, per oral, once daily
Other Names:
  • Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
Time Frame: Baseline, Week 18
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.
Baseline, Week 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18
Time Frame: Week 18 (Last Observation Carried Forward)
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)
Week 18 (Last Observation Carried Forward)
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)
Time Frame: Baseline, Week 18 (Last Observation Carried Forward)
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Baseline, Week 18 (Last Observation Carried Forward)
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
Time Frame: Baseline, Week 18 (Last Observation Carried Forward)
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Baseline, Week 18 (Last Observation Carried Forward)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Peter Öhman, MD, PhD, AstraZeneca, Wilmington, USA
  • Study Chair: Deborah Price, MSc, AstraZeneca, Wilmington, USA
  • Principal Investigator: André Scheen, Professor, Clinical Pharmacology Unit, Liege, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 15, 2010

Last Update Submitted That Met QC Criteria

March 5, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1680C00002
  • EudraCT number 2007-006095-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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