Type 2 Diabetes MellitusPhase 4GENERATIONNCT01006603

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

A Phase 4 study testing Saxagliptin and Glimepiride in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 131 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Saxagliptin and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 957 participants
Where: 131 sitesin 13 countries
Study dates: Oct 2009to Jun 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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%

Who cannot join

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

Trial locations and contacts

131 sites in 13 countries.

Country

City, postcode or hospital

131 sites in 13 countries

United Kingdom20 sites

Research Site
Annan, Dumfries and Galloway
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Ayrshire
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Barnstaple, Devon
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Bath
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Bradford on Avon, Wiltshire
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Canterbury, Kent
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Cumbernauld
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Dundee
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Fowey, Cornwall
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Frome, Somerset
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Hamilton
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Middlesex
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Motherwell
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Nr Penzance, Cornwall
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Penzance, Cornwall
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Plymouth, Devon
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Somerset
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Trowbridge, Wiltshire
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Wellingborough
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Whitstable, Kent

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Norway18 sites

Research Site
Aksdal
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Ålesund
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Elverum
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Halden
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Hamar
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Kirkenær
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Kongsvinger
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Larvik
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Lierskogen
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Nordlenangen
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Oslo
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Røa
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Sandvika
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Skedsmokorset
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Sørumsand
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Svelvik
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Trondheim
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Ulset

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Germany16 sites

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Augsburg
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Darmstadt
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Dresden
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Essen
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Gelnhausen
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Hamburg, Free and Hanseatic City of Hamburg
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Hamburg
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Magdeburg
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Mayen
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München
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Neumünster
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Nuremberg
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Pirna
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Ratzeburg
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Reinfeld
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Sulzbach

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Sweden13 sites

Research Site
Finspång
Research Site
Gävle
Research Site
Gothenburg
Research Site
Jarfalla
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Jönköping, Sweden
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Lessebo
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Lund
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Ödeshög
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Piteå
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Rättvik
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Stockholm
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Trollhättan
Research Site
Västervik

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Finland12 sites

Research Site
Harjavalta
Research Site
Helsinki
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Kuopio
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Kuusankoski
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Lahti, Finland
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Oulu
Research Site
Seinäjoki
Research Site
Sipoo
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Tampere
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Turku
Research Site
Vantaa, Finland
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Vimpeli

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Denmark10 sites

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Aalborg
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Ans
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Kjellerup
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Kolding
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Nørresundby
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Roskilde
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Roslev
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Værløse
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Viborg
Research Site
Viby J

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Italy9 sites

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Chieti
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Milan, MI
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Naples
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Padova, PD
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Palermo, PA
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Pordenone, PN
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Reggio Emilia, RE
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Roma
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Viterbo

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Spain9 sites

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A Coruña, Galicia
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Alicante, Valencia
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Begonte (lugo), Galicia
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Getafe, Madrid
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Madrid, Madrid
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Oviedo, Principality of Asturias
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San Sebastián de los Reyes, Madrid
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Seville, Andalusia
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Zamora, Castille and León

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France7 sites

Research Site
Châtellerault
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La Rochelle
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La Seyne-sur-Mer
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Laval
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Seysses
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Strasbourg
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Tiercé

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Hungary6 sites

Research Site
Ács
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Balatonfüred
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Budapest
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Érd
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Gyöngyös
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Komárom

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Austria4 sites

Research Site
Feldbach
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Graz
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Salzburg
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Vienna

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Greece4 sites

Research Site
Athens, Greece
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Athens
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Nikaia
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Thessaloniki

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Mexico3 sites

Research Site
Durango, Durango
Research Site
Guadalajara, Jalisco
Research Site
Monterrey, Nuevo León

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About this study

Official title: 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

Conditions: Type 2 Diabetes Mellitus
Being tested: Saxagliptin, Glimepiride
Keywords: Type 2 Diabetes Mellitus, elderly patients, saxagliptin, randomised, double-blind
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SaxagliptinDrug
Also called Onglyza
5 mg, oral tablet, once daily
GlimepirideDrug
Also called Amaryl
1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily

Study groups in NCT01006603
Study group	Role	What they receive
1	Experimental	Saxagliptin 5 mg Receives: Drug: Saxagliptin
2	Active comparator	Glimepiride 1 - 6 mg Receives: Drug: Glimepiride

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.
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.
Measured: From week 0 to week 52.

Secondary outcomes (6)

Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.
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.
Measured: From week 0 to week 52.
Change From Baseline to Week 52 in HbA1c.
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.
Measured: From week 0 to week 52.
Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%
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.
Measured: From week 0 to week 52
Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
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.
Measured: From week 0 to week 52
Change From Baseline to Week 52 in Insulin
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.
Measured: 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]
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.
Measured: From week 0 to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Jun 2012

First posted3 Nov 2009 (estimated)
Study startOct 2009
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 957 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01006603
Sponsor's protocol ID: D1680L00002
Acronym: GENERATION
Status last verified: Sep 2013
First submitted: 31 Oct 2009
Last updated: 28 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Perl S, Cook W, Wei C, Ohman P, Hirshberg B. Effects of Glimepiride versus Saxagliptin on beta-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Clin Ther. 2016 Dec;38(12):2578-2588. doi: 10.1016/j.clinthera.2016.10.006. Epub 2016 Nov 4.
PubMed 27823868
Schernthaner G, Duran-Garcia S, Hanefeld M, Langslet G, Niskanen L, Ostgren CJ, Malvolti E, Hardy E. Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Diabetes Obes Metab. 2015 Jul;17(7):630-8. doi: 10.1111/dom.12461. Epub 2015 Apr 7.
PubMed 25761977

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01006603
Acronym / sponsor ID: GENERATION / D1680L00002
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, elderly patients, saxagliptin, randomised, double-blind
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 957 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Oct 2009
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 3 Nov 2009 (estimated)
Results: Posted 28 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: SaxagliptinSaxagliptin 5 mg
2	Active comparator	Drug: GlimepirideGlimepiride 1 - 6 mg

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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%

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SaxagliptinAlso: Onglyza5 mg, oral tablet, once daily	Drug	1
GlimepirideAlso: Amaryl1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily	Drug	2

Primary outcome

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.

6 secondary outcomes

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.
Change From Baseline to Week 52 in HbA1c.
Time frame: 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
Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
Time frame: From week 0 to week 52
Change From Baseline to Week 52 in Insulin
Time frame: 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

Results and safety

Results posted to the registry on 28 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saxagliptin 5 mg	360	289
Glimepiride 1 - 6 mg	360	285

Primary outcome: Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.

Time frame: From week 0 to week 52.. Number. Unit: percentage of participants

Measure	Saxagliptin 5 mg n = 359	Glimepiride 1 - 6 mg n = 359
All patients	37.9	38.2
patients aged <75 years (n=217, n=216)	39.2	33.3
patients aged ≥75 years (n=142, n=143)	35.9	45.5

Population analysed: Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saxagliptin 5 mg	41 of 359 (11.4%)	130 of 359 (36.2%)	Not reported
Glimepiride 1 - 6 mg	32 of 359 (8.9%)	129 of 359 (35.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27823868Perl S, Cook W, Wei C, Ohman P, Hirshberg B. Effects of Glimepiride versus Saxagliptin on beta-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Clin Ther. 2016 Dec;38(12):2578-2588. doi: 10.1016/j.clinthera.2016.10.006. Epub 2016 Nov 4.
Derived from this study: PubMed 25761977Schernthaner G, Duran-Garcia S, Hanefeld M, Langslet G, Niskanen L, Ostgren CJ, Malvolti E, Hardy E. Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Diabetes Obes Metab. 2015 Jul;17(7):630-8. doi: 10.1111/dom.12461. Epub 2015 Apr 7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

131 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saxagliptin and Glimepiride in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 131 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United Kingdom, Norway, Germany, Sweden, Finland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. (time frame: From week 0 to week 52.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01006603, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.