Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes (PROMPT)

January 16, 2012 updated by: AstraZeneca

A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 4

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

  • Belgium
      • Brugge, Belgium
        • Research Site
      • Brussels (woluwe-st-lambert), Belgium
        • Research Site
      • Halen, Belgium
        • Research Site
      • Lommel, Belgium
        • Research Site
      • Moerkerke, Belgium
        • Research Site
      • Oostham, Belgium
        • Research Site
      • Sint-gillis-waas, Belgium
        • Research Site
      • Tielt, Belgium
        • Research Site
      • Zoersel, Belgium
        • Research Site
  • France
      • Chatellerault, France
        • Research Site
      • Corbeil Essonnes, France
        • Research Site
      • La Rochelle, France
        • Research Site
      • La Seyne Sur Mer, France
        • Research Site
      • Paris, France
        • Research Site
      • Seysses, France
        • Research Site
      • Tierce, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Freiburg, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Rhaunen, Germany
        • Research Site
      • Schmiedeberg, Germany
        • Research Site
      • Wahlstedt, Germany
        • Research Site
  • Italy
      • Roma, Italy
        • Research Site
    • BG
      • Bergamo, BG, Italy
        • Research Site
    • FC
      • Forli, FC, Italy
        • Research Site
    • MI
      • Milano, MI, Italy
        • Research Site
    • PD
      • Padova, PD, Italy
        • Research Site
    • PN
      • Pordenone, PN, Italy
        • Research Site
    • SI
      • Siena, SI, Italy
        • Research Site
  • Spain
    • Andalucia
      • Sevilla, Andalucia, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spain
        • Research Site
      • San Sebastian de Los Reyes, Comunidad de Madrid, Spain
        • Research Site
    • Galicia
      • A Coruna, Galicia, Spain
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Bursa, Turkey
        • Research Site
      • Kirikkale, Turkey
        • Research Site
  • United Kingdom
      • Ashford, United Kingdom
        • Research Site
      • Bath, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Peterborough, United Kingdom
        • Research Site
    • Berks
      • Reading, Berks, United Kingdom
        • Research Site
    • Warwickshire
      • Atherstone, Warwickshire, United Kingdom
        • Research Site
    • Warwks
      • Leamington Spa, Warwks, United Kingdom
        • Research Site
    • Wiltshire
      • Warminster, Wiltshire, United Kingdom
        • Research Site
      • Westbury, Wiltshire, United Kingdom
        • 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:

  • Provision of signed informed consent
  • Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
  • HbA1c ≥7.0% and ≤10.0%

Exclusion Criteria:

  • Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
  • Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
  • Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Saxagliptin 5 mg
Drug: Saxagliptin
5 mg, oral tablet, once daily
Other Names:
  • Onglyza
ACTIVE_COMPARATOR: 2
Metformin 500 -1000 mg
Drug: Metformin
500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute Change From Baseline in HbA1c at Week 24
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%
Time Frame: 24 Weeks
Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent
24 Weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%
Time Frame: 24 Weeks
Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent
24 Weeks
Change From Baseline to Week 24 in Fasting Plasma Glucose
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks
Change From Baseline to Week 24 in Fasting Insulin
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks
Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

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

October 1, 2009

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

October 31, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (ESTIMATE)

November 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1680L00003

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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