Diabetes Mellitus, Type 2Phase 3NCT00851903
Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial
A Phase 3 study testing Insulin Glargine, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 16 sites in 16 countries.
Trial summary
This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled). Read more about this study
- Who is it for?
- Ages 35 to 71 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
- 112 participants
- Where
- 16 sitesin 16 countries
- Study dates
- Jun 2009to Sep 2011
- Phase
- Phase 3
- 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 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who completed the core study LANTU_C_02761 (NCT00751114) i.e. went through the visit 14 investigation,
- HbA1c >= 7 %,
- Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the core study
- Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy,
- Signed informed consent obtained prior any study procedure,
- Willingness and ability to comply with the study protocol.
Who cannot join
- Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,
- Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),
- Treatment with a non-permitted drug during the core study,
- Pregnant or lactating women,
- 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 in the core study),
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- 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,
- 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),
- History of pancreatitis.
Trial locations and contacts
16 sites in 16 countries.
16 sites in 16 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin
This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).
All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria.
Read more
The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.
The objectives of this extension study were:
- To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin.
- To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and 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 prefilled SoloStar® pen (3 mL).
SitagliptinDrug
Also called Januvia®
Oral administration. 100mg film-coated tablets.
MetforminDrug
Patients continued with metformin as usual oral anti-diabetic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Combination insulin glargine and sitagliptin | Experimental | Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).
Sitagliptin: stable dose of 100 mg once a day administered with or without food. Receives: Drug: Insulin Glargine; Drug: Sitagliptin; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)
Measured: study endpoint: week 12 or earlier in case of premature discontinuation
Secondary outcomes (6)
HbA1c: Change From Baseline to Study Endpoint
Change = study endpoint - baseline
Measured: baseline, study endpoint: week 12 or earlier in case of premature discontinuation
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).
Change = study endpoint - baseline.
Measured: baseline, study endpoint: week 12 or week 8 if value not available at week 12
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, study endpoint: week 12 or week 8 if value not available at week 12
Insulin Dose
Daily dose at the face-to-face visits
Measured: baseline, week 4, week 8, week 12
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 period (12 weeks) plus 7 days after last dose
Change in Body Weight From Baseline to Study Endpoint
Change = study endpoint - baseline
Measured: baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2011
- Study completionSep 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851903
- Sponsor's protocol ID
- EXT_LANTU_C_02761
- Other IDs
- 2008-000521-19, 2008
- Status last verified
- Sep 2012
- First submitted
- 25 Feb 2009
- Last updated
- 4 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin
- ClinicalTrials.gov ID
- NCT00851903
- Acronym / sponsor ID
- EXT_LANTU_C_02761
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Posted 4 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).
All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria.
The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.
The objectives of this extension study were:
- To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin.
- To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination insulin glargine and sitagliptin | Experimental | Drug: Insulin Glargine, Drug: Sitagliptin, Drug: MetforminInsulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L). Sitagliptin: stable dose of 100 mg once a day administered with or without food. |
Who may qualify
- Ages
- 35 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who completed the core study LANTU_C_02761 (NCT00751114) i.e. went through the visit 14 investigation,
- HbA1c >= 7 %,
- Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the core study
- Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy,
- Signed informed consent obtained prior any study procedure,
Key exclusion criteria (14 listed)
- Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,
- Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),
- Treatment with a non-permitted drug during the core study,
- Pregnant or lactating women,
- In-patient care,
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 prefilled SoloStar® pen (3 mL). | Drug | Combination insulin glargine and sitagliptin |
| SitagliptinAlso: Januvia®Oral administration. 100mg film-coated tablets. | Drug | Combination insulin glargine and sitagliptin |
| MetforminPatients continued with metformin as usual oral anti-diabetic treatment. | Drug | Combination insulin glargine and sitagliptin |
Primary outcome
HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)
Time frame: study endpoint: week 12 or earlier in case of premature discontinuation
6 secondary outcomes
HbA1c: Change From Baseline to Study Endpoint
Time frame: baseline, study endpoint: week 12 or earlier in case of premature discontinuation
Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
Time frame: baseline, study endpoint: week 12 or week 8 if value not available at week 12
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
Time frame: baseline, study endpoint: week 12 or week 8 if value not available at week 12
Insulin Dose
Time frame: baseline, week 4, week 8, week 12
Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
Time frame: During the treatment period (12 weeks) plus 7 days after last dose
Change in Body Weight From Baseline to Study Endpoint
Time frame: baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
16 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glargine, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 16 sites in 16 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 6 inclusion and 14 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 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Austria, Brazil, Colombia, Egypt and 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Oct 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 Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period) (time frame: study endpoint: week 12 or earlier in case of premature discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2012.