Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin (GENERATION)

September 27, 2013 updated by: AstraZeneca

A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy

This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

957

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

  • Austria
      • Feldbach, Austria
        • Research Site
      • Graz, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Vienna, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Ans by, Denmark
        • Research Site
      • Kjellerup, Denmark
        • Research Site
      • Kolding, Denmark
        • Research Site
      • Norresundby, Denmark
        • Research Site
      • Roskilde, Denmark
        • Research Site
      • Roslev, Denmark
        • Research Site
      • Vaerlose, Denmark
        • Research Site
      • Viborg, Denmark
        • Research Site
      • Viby J, Denmark
        • Research Site
  • Finland
      • Harjavalta, Finland
        • Research Site
      • Helsinki, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Kuusankoski, Finland
        • Research Site
      • Lahti, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Seinajoki, Finland
        • Research Site
      • Sipoo, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Turku, Finland
        • Research Site
      • Vantaa, Finland
        • Research Site
      • Vimpeli, Finland
        • Research Site
  • France
      • Chatellerault, France
        • Research Site
      • La Rochelle, France
        • Research Site
      • La Seyne Sur Mer, France
        • Research Site
      • Laval, France
        • Research Site
      • Seysses, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Tierce, France
        • Research Site
  • Germany
      • Augsburg, Germany
        • Research Site
      • Darmstadt, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Gelnhausen, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Mayen, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Neumunster, Germany
        • Research Site
      • Nurnberg, Germany
        • Research Site
      • Pirna, Germany
        • Research Site
      • Ratzeburg, Germany
        • Research Site
      • Reinfeld, Germany
        • Research Site
      • Sulzbach, Germany
        • Research Site
    • HH
      • Hamburg, HH, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Nikea, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Hungary
      • ACS, Hungary
        • Research Site
      • Balatonfured, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • ERD, Hungary
        • Research Site
      • Gyongyos, Hungary
        • Research Site
      • Komarom, Hungary
        • Research Site
  • Italy
      • Chieti, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Viterbo, Italy
        • Research Site
    • MI
      • Milano, MI, Italy
        • Research Site
    • PA
      • Palermo, PA, Italy
        • Research Site
    • PD
      • Padova, PD, Italy
        • Research Site
    • PN
      • Pordenone, PN, Italy
        • Research Site
    • RE
      • Reggio Emilia, RE, Italy
        • Research Site
  • Mexico
      • Durango, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site
  • Norway
      • Aksdal, Norway
        • Research Site
      • Alesund, Norway
        • Research Site
      • Elverum, Norway
        • Research Site
      • Halden, Norway
        • Research Site
      • Hamar, Norway
        • Research Site
      • Kirkenaer, Norway
        • Research Site
      • Kongsvinger, Norway
        • Research Site
      • Larvik, Norway
        • Research Site
      • Lierskogen, Norway
        • Research Site
      • Nord-lenangen, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • ROA, Norway
        • Research Site
      • Sandvika, Norway
        • Research Site
      • Skedsmokorset, Norway
        • Research Site
      • Sorumsand, Norway
        • Research Site
      • Svelvik, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
      • Ulset, Norway
        • Research Site
  • Spain
    • Andalucia
      • Sevilla, Andalucia, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Castilla Y Leon
      • Zamora, Castilla Y Leon, Spain
        • Research Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Getafe, Comunidad de Madrid, Spain
        • Research Site
      • 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
      • Begonte (lugo), Galicia, Spain
        • Research Site
  • Sweden
      • Finspang, Sweden
        • Research Site
      • Gavle, Sweden
        • Research Site
      • Goteborg, Sweden
        • Research Site
      • Jarfalla, Sweden
        • Research Site
      • Jonkoping, Sweden
        • Research Site
      • Lessebo, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Odeshog, Sweden
        • Research Site
      • Pitea, Sweden
        • Research Site
      • Rattvik, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Trollhattan, Sweden
        • Research Site
      • Vastervik, Sweden
        • Research Site
  • United Kingdom
      • Ayrshire, United Kingdom
        • Research Site
      • Bath, United Kingdom
        • Research Site
      • Cumbernauld, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Hamilton, United Kingdom
        • Research Site
      • Middlesex, United Kingdom
        • Research Site
      • Motherwell, United Kingdom
        • Research Site
      • Somerset, United Kingdom
        • Research Site
      • Wellingborough, United Kingdom
        • Research Site
    • Cornwall
      • Fowey, Cornwall, United Kingdom
        • Research Site
      • Nr Penzance, Cornwall, United Kingdom
        • Research Site
      • Penzance, Cornwall, United Kingdom
        • Research Site
    • Devon
      • Barnstaple, Devon, United Kingdom
        • Research Site
      • Plymouth, Devon, United Kingdom
        • Research Site
    • Dumfries and Galloway
      • Annan, Dumfries and Galloway, United Kingdom
        • Research Site
    • Kent
      • Canterbury, Kent, United Kingdom
        • Research Site
      • Whitstable, Kent, United Kingdom
        • Research Site
    • Somerset
      • Frome, Somerset, United Kingdom
        • Research Site
    • Wiltshire
      • Bradford-on-avon, Wiltshire, United Kingdom
        • Research Site
      • Trowbridge, 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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin monotherapy, for at least 8 weeks prior to Visit 1
  • HbA1c ≥7.0% and ≤9.0%

Exclusion Criteria:

  • Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Current use of any injectable or oral antihyperglycemic agent excluding metformin.
  • Renal impairment as defined by a creatinine clearance <60 mL/min
  • 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 Assignment
  • Masking: Double

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
Glimepiride 1 - 6 mg
Drug: Glimepiride
1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
Other Names:
  • Amaryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.
Time Frame: From week 0 to week 52.

Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.

Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).

Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration.
From week 0 to week 52.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.
Time Frame: From week 0 to week 52.

Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).

Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set.
From week 0 to week 52.
Change From Baseline to Week 52 in HbA1c.
Time Frame: From week 0 to week 52.
Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.
From week 0 to week 52.
Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%
Time Frame: From week 0 to week 52
Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set.
From week 0 to week 52
Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
Time Frame: From week 0 to week 52
Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set.
From week 0 to week 52
Change From Baseline to Week 52 in Insulin
Time Frame: From week 0 to week 52
Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set.
From week 0 to week 52
Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]
Time Frame: From week 0 to week 52
β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.
From week 0 to week 52

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

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

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)

November 28, 2013

Last Update Submitted That Met QC Criteria

September 27, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1680L00002

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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