52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

March 20, 2012 updated by: AstraZeneca

A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy 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 sulphonylurea in addition with metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

891

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

  • Finland
      • Hanko, Finland
        • Research Site
      • Helsinki, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Kuusankoski, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
  • Germany
      • Aschaffenburg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Dortmund, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Mulheim, Germany
        • Research Site
      • Pirna, Germany
        • Research Site
      • Ratzeburg, Germany
        • Research Site
      • Reinfeld, Germany
        • Research Site
      • Rhaunen, Germany
        • Research Site
      • Schmiedeberg, Germany
        • Research Site
      • Tubingen, Germany
        • Research Site
      • Wahlstedt, Germany
        • Research Site
      • Weinheim, Germany
        • Research Site
  • Hungary
      • Balatonfured, Hungary
        • Research Site
      • Bekescsaba, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Kalocsa, Hungary
        • Research Site
      • Kaposvar, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Mosonmagyarovar, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Research Site
    • Mashatra
      • Mumbai, Mashatra, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Uijeongbu-si, Korea, Republic of
        • Research Site
    • Gyeonggi-do
      • Guri, Gyeonggi-do, Korea, Republic of
        • Research Site
      • Seongnam, Gyeonggi-do, Korea, Republic of
        • Research Site
    • Kangwon-do
      • Wonju, Kangwon-do, Korea, Republic of
        • Research Site
  • Netherlands
      • Beek En Donk, Netherlands
        • Research Site
      • Den Bosch, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Deurne, Netherlands
        • Research Site
      • Dordrecht, Netherlands
        • Research Site
      • Losser, Netherlands
        • Research Site
      • Nijverdal, Netherlands
        • Research Site
      • Rijswijk, Netherlands
        • Research Site
      • Roelofarendsveen, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Volendam, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Elverum, Norway
        • Research Site
      • Flatasen, Norway
        • Research Site
      • Hamar, Norway
        • Research Site
      • Honefoss, Norway
        • Research Site
      • Inderoy, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Radal, Norway
        • Research Site
      • Skedsmokorset, Norway
        • Research Site
      • Sogndal, Norway
        • Research Site
      • Spikkestad, Norway
        • Research Site
      • Trollasen, Norway
        • Research Site
  • Russian Federation
      • Kazan, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhnii Novgorod, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Slovakia
      • Dolny Kubin, Slovakia
        • Research Site
      • Kosice - Tahanovce, Slovakia
        • Research Site
      • Moldava Nad Bodvou, Slovakia
        • Research Site
      • Ruzomberok, Slovakia
        • Research Site
      • Trnava, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
  • United Kingdom
      • Blackpool, United Kingdom
        • Research Site
      • Coatbridge, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Motherwell, United Kingdom
        • Research Site
      • Newcastle, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
    • Dumfries and Galloway
      • Annan, Dumfries and Galloway, United Kingdom
        • Research Site
    • Kent
      • Whitstable, Kent, United Kingdom
        • Research Site
    • Lanarkshire
      • Hamilton, Lanarkshire, United Kingdom
        • Research Site
    • Manchester
      • Salford, Manchester, United Kingdom
        • Research Site
    • West Sussex
      • Crawley, West Sussex, United Kingdom
        • Research Site
    • Wiltshire
      • Bradford-on-avon, Wiltshire, United Kingdom
        • Research Site
  • Vietnam
      • Ho Chi Minh, Vietnam
        • Research Site
      • Ho Chi Minh City, Vietnam
        • 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 prior to Visit 1,
  • HbA1c >6.5% and ≤10.0%

Exclusion Criteria:

  • Type 1 diabetes,
  • history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
  • Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)

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: Saxagliptin
Drug: Metformin
open-label metformin
Drug: Saxagliptin
Saxagliptin 5 mg tablets
Other Names:
  • Onglyza
Experimental: Glipizide
Drug: Metformin
open-label metformin
Drug: Sulphonylurea
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Time Frame: Baseline to 52 Weeks
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
Baseline to 52 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
Time Frame: From Baseline to Week 52
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
From Baseline to Week 52
Body Weight Change From Baseline to Week 52
Time Frame: Baseline, Week 52 (Last Observation Carried Forward)
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
Baseline, Week 52 (Last Observation Carried Forward)
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Time Frame: Week 24 to Week 52
Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Week 24 to Week 52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c) Change From Baseline to Week 104
Time Frame: Baseline, Week 104
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.
Baseline, Week 104
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks
Time Frame: Baseline, Week 104
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)
Baseline, Week 104
Body Weight Change From Baseline to Week 104
Time Frame: Baseline, Week 104
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.
Baseline, Week 104
Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c
Time Frame: Week 24 to Week 104
Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Week 24 to Week 104

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Chair: Deborah Price, MSc, AstraZeneca
  • Principal Investigator: Burkhard Goke, University of Munich, Germany
  • Study Director: Peter Ohman, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1680C00001
  • EudraCT number 2007-003998-55

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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