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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
891

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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