Diabetes Mellitus, Type 2Phase 4EASIENCT00751114

Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

A Phase 4 study testing Insulin Glargine, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 17 sites in 17 countries.

Completed

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

Official record

Search all trials

Trial summary

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Read more about this study

Who is it for?: Ages 35 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin Glargine, Sitagliptin and Metformin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 515 participants
Where: 17 sitesin 17 countries
Study dates: Nov 2008to Jul 2011
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 35 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

With type 2 diabetes diagnosed for at least 6 months,
Not previously treated with insulin,
On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months
HbA1c ≥ 7 and < 11 %,
Body Mass Index (BMI) between 25 and 45 kg/m² inclusively,
Ability and willingness to perform plasma glucose (PG) monitoring using the Sponsor-provided PG meter and to complete the patient diary,
Signed informed consent obtained prior any study procedures,
Willingness and ability to comply with the study protocol.

Who cannot join

Treatment with oral antidiabetic drugs other than metformin within the last 3 months,
Previous treatment with the combination of metformin + sulfonylurea for more than 1 year,
Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonists or DiPeptidyl Peptidase (DPP) IV inhibitors,
FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L),
Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake...),
Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),

Show all 18Show fewer

In-patient care,
Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry),
Impaired renal function: serum creatinine ≥ 1.5 mg/dL (≥ 133µmol/L) or ≥ 1.4 mg/dL (≥ 124 µmol/L) in men and women, respectively,
History of sensitivity to the study drugs or to drugs with a similar chemical structure,
Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 3 x upper limit of normal range,
Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatment during the study that are not permitted during the study (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are accepted only if the disease is stable and the treatment dose stable for at least 3 months before study entry),
Alcohol or drug abuse within the last year,
Night shift worker,
Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant) within the last 3 months,
Participation in another clinical trial within the month prior to visit 1,
History of pancreatitis.

Trial locations and contacts

17 sites in 17 countries.

Country

City, postcode or hospital

17 sites in 17 countries

United States1 site

Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807

Other trials in United States

Austria1 site

Sanofi-Aventis Administrative Office
Vienna

Other trials in Austria

Brazil1 site

Sanofi-Aventis Administrative Office
São Paulo

Other trials in Brazil

Colombia1 site

Sanofi-Aventis Administrative Office
Bogotá

Other trials in Colombia

Egypt1 site

Sanofi-Aventis Administrative Office
Cairo

Other trials in Egypt

Greece1 site

Sanofi-Aventis Administrative Office
Kallithea

Other trials in Greece

Hong Kong1 site

Sanofi-Aventis Administrative Office
Hong Kong

Other trials in Hong Kong

India1 site

Sanofi-Aventis Administrative Office
Mumbai

Other trials in India

Israel1 site

Sanofi-Aventis Administrative Office
Netanya

Other trials in Israel

Lebanon1 site

Sanofi-Aventis Administrative Office
Beirut

Other trials in Lebanon

Mexico1 site

Sanofi-Aventis Administrative Office
Col. Coyoacan

Other trials in Mexico

Netherlands1 site

Sanofi-Aventis Administrative Office
Gouda

Other trials in Netherlands

Portugal1 site

Sanofi-Aventis Administrative Office
Porto Salvo

Other trials in Portugal

South Korea1 site

Sanofi-Aventis Administrative Office
Seoul

Other trials in South Korea

Spain1 site

Sanofi-Aventis Administrative Office
Barcelona

Other trials in Spain

Turkey (Türkiye)1 site

Sanofi-Aventis Administrative Office
Istanbul

Other trials in Turkey (Türkiye)

United Kingdom1 site

Sanofi-Aventis Administrative Office
Guildford Surrey

Other trials in United Kingdom

About this study

Official title: Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-naïve Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.

Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:

HbA1c level
Fasting Plasma Glucose (FPG)
7-point plasma glucose (PG) profiles
Percentage of patients with HbA1c <7% and <6.5%

Safety objectives consisted of:

Hypoglycemia occurrence
Body weight
Overall safety

Conditions: Diabetes Mellitus, Type 2
Being tested: Insulin Glargine, Sitagliptin, Metformin
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.

Insulin GlargineDrug
Also called Lantus®
Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL).
SitagliptinDrug
Also called Januvia®
Oral administration. 100 mg film-coated tablets.
MetforminDrug
Patients continued with metformin as usual oral anti-diabetic treatment.

Study groups in NCT00751114
Study group	Role	What they receive
Insulin Glargine	Experimental	Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L). Receives: Drug: Insulin Glargine; Drug: Metformin
Sitagliptin	Active comparator	Dose of 100 mg once a day administered with or without food. Receives: Drug: Sitagliptin; Drug: Metformin

What is being measured

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

HbA1c: Change From Baseline to Study Endpoint
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.
Measured: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14

Secondary outcomes (9)

HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint
Measured: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint
Measured: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).
Study endpoint was defined as the last available SMFPG mean value collected on-treatment.
Change= study endpoint - baseline
Measured: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.
Change = study endpoint - baseline.
Measured: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Insulin Dose in the Insulin Glargine Group
Daily dose at the face-to-face visits.
Measured: visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value
Lipid Profile: Change From Baseline to Study Endpoint
Measured: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Change in Body Weight From Baseline to Study Endpoint
Measured: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]
Measured: During the treatment phase (24 weeks) plus 7 days after last dose
Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia
Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
Measured: During the treatment phase (24 weeks) plus 7 days after last dose

Timeline

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

Nov 2008Jul 2011

First posted11 Sep 2008 (estimated)
Study startNov 2008
Primary completionJul 2011
Study completionJul 2011

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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by SanofiThe 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: None (open label)
Enrolment: 515 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00751114
Sponsor's protocol ID: LANTU_C_02761
Other IDs: 2008-000516-32, 2008
Acronym: EASIE
Status last verified: Sep 2012
First submitted: 10 Sep 2008
Last updated: 10 Sep 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Aschner P, Chan J, Owens DR, Picard S, Wang E, Dain MP, Pilorget V, Echtay A, Fonseca V; EASIE investigators. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet. 2012 Jun 16;379(9833):2262-9. doi: 10.1016/S0140-6736(12)60439-5. Epub 2012 Jun 9.
PubMed 22683131
Chan JC, Aschner P, Owens DR, Picard S, Vincent M, Dain MP, Pilorget V, Loizeau V, Echtay A, Fonseca V. Triple combination of insulin glargine, sitagliptin and metformin in type 2 diabetes: the EASIE post-hoc analysis and extension trial. J Diabetes Complications. 2015 Jan-Feb;29(1):134-41. doi: 10.1016/j.jdiacomp.2014.08.007. Epub 2014 Aug 27.
PubMed 25283485

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 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-naïve Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled
ClinicalTrials.gov ID: NCT00751114
Acronym / sponsor ID: EASIE / LANTU_C_02761
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 515 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 11 Sep 2008 (estimated)
Results: Posted 15 Aug 2012

Clinical summary

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

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.

Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:

HbA1c level
Fasting Plasma Glucose (FPG)
7-point plasma glucose (PG) profiles
Percentage of patients with HbA1c <7% and <6.5%

Safety objectives consisted of:

Hypoglycemia occurrence
Body weight
Overall safety

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin Glargine	Experimental	Drug: Insulin Glargine, Drug: MetforminAdministered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L).
Sitagliptin	Active comparator	Drug: Sitagliptin, Drug: MetforminDose of 100 mg once a day administered with or without food.

Who may qualify

Ages: 35 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

With type 2 diabetes diagnosed for at least 6 months,
Not previously treated with insulin,
On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months
HbA1c ≥ 7 and < 11 %,
Body Mass Index (BMI) between 25 and 45 kg/m² inclusively,

Key exclusion criteria (18 listed)

Treatment with oral antidiabetic drugs other than metformin within the last 3 months,
Previous treatment with the combination of metformin + sulfonylurea for more than 1 year,
Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonists or DiPeptidyl Peptidase (DPP) IV inhibitors,
FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L),
Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake...),

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
Insulin GlargineAlso: Lantus®Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL).	Drug	Insulin Glargine
SitagliptinAlso: Januvia®Oral administration. 100 mg film-coated tablets.	Drug	Sitagliptin
MetforminPatients continued with metformin as usual oral anti-diabetic treatment.	Drug	Insulin Glargine, Sitagliptin

Primary outcome

HbA1c: Change From Baseline to Study Endpoint
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.

9 secondary outcomes

HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint
Time frame: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint
Time frame: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Insulin Dose in the Insulin Glargine Group
Time frame: visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value
Lipid Profile: Change From Baseline to Study Endpoint
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Change in Body Weight From Baseline to Study Endpoint
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
Time frame: During the treatment phase (24 weeks) plus 7 days after last dose
Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia
Time frame: During the treatment phase (24 weeks) plus 7 days after last dose

Results and safety

Results posted to the registry on 15 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Glargine	250	212
Sitagliptin	265	233

Primary outcome: HbA1c: Change From Baseline to Study Endpoint

Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14. Least squares mean (Standard Error). Unit: percent

Measure	Insulin Glargine n = 224	Sitagliptin n = 248
Value	-1.72 (0.06)	-1.13 (0.06)

Insulin Glargine vs Sitagliptin: adjusted mean difference: -0.59 (95% CI -0.77 to -0.42), p <0.0001, ANCOVA

Population analysed: The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements. The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Glargine	15 of 237 (6.3%)	27 of 237 (11.4%)	Not reported
Sitagliptin	8 of 264 (3%)	41 of 264 (15.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22683131Aschner P, Chan J, Owens DR, Picard S, Wang E, Dain MP, Pilorget V, Echtay A, Fonseca V; EASIE investigators. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet. 2012 Jun 16;379(9833):2262-9. doi: 10.1016/S0140-6736(12)60439-5. Epub 2012 Jun 9.
Derived from this study: PubMed 25283485Chan JC, Aschner P, Owens DR, Picard S, Vincent M, Dain MP, Pilorget V, Loizeau V, Echtay A, Fonseca V. Triple combination of insulin glargine, sitagliptin and metformin in type 2 diabetes: the EASIE post-hoc analysis and extension trial. J Diabetes Complications. 2015 Jan-Feb;29(1):134-41. doi: 10.1016/j.jdiacomp.2014.08.007. Epub 2014 Aug 27.

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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.

Clinical Sciences & Operations study director

Sanofi

17 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Glargine, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 17 sites in 17 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 8 inclusion and 18 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Austria, Brazil, Colombia, Egypt and 12 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 15 Aug 2012). 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?

HbA1c: Change From Baseline to Study Endpoint (time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14). 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 NCT00751114, 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 10 Sep 2012.