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Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure (EAGLE)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Insulin glargine
Liraglutide
Metformin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria (comparative period):

  • Patients With Type 2 Diabetes diagnosed for at least 1 year,
  • Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months,
  • 7.5% < HbA1c <= 12%,
  • Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively,
  • Ability and willingness to perform PG (Plasma Glucose) self monitoring using the sponsor-provided glucose meter and to complete the patient diary,
  • Willingness and ability to comply with the study protocol,
  • Signed informed consent obtained prior to any study procedure.

Inclusion criteria (extension period):

  • Patients treated with liraglutide (at the maximal tolerated dosage), having a mean FPG ≥ 250 mg/dL at visit 10 (Week 12) or visit 11 (Week 18), or a HbA1c≥ 7% at visit 12 (Week 24)
  • Dosage of metformin compliant with the inclusion criteria of visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period.

Exclusion criteria:

  • Previous treatment with Glucagon Like Peptide-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization...),
  • Treatment with thiazolidinediones or α-Glucosidases inhibitors within 3 months prior to study entry,
  • Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake),
  • Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method),
  • Lactating women,
  • Hospitalized patients (except hospitalization for routine diabetes check-up),
  • Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,
  • Impaired renal function (creatinine clearance < 60 mL/mn),
  • Impaired hepatic function (Alanine Aminotransferase, Aspartate Aminotransferase 2.5 times the upper limit of normal range),
  • Personal or family history of medullary thyroid carcinoma,
  • Multiple endocrine neoplasia syndrome type 2,
  • Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis),
  • Congestive heart failure,
  • History of acute pancreatitis,
  • Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry,
  • Alcohol or drug abuse in the past 5 years,
  • History of sensitivity to the study drugs or to drugs with a similar chemical structure.
  • Night shift worker,
  • Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patients safety or limit the patient successful participation in the study,
  • Participation in a clinical trial (drug or device) within 3 months prior to study entry,
  • Refusal or inability to give informed consent to participate in the study,
  • Patient is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

Additional exclusion criteria for the extension period:

  • Treatment with oral antidiabetic drugs other than metformin and patient's usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),
  • Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period.
  • History of sensitivity to insulin glargine.

Sites / Locations

  • Investigational Site Number 840023
  • Investigational Site Number 840002
  • Investigational Site Number 840047
  • Investigational Site Number 840017
  • Investigational Site Number 840036
  • Investigational Site Number 840037
  • Investigational Site Number 840045
  • Investigational Site Number 840048
  • Investigational Site Number 840033
  • Investigational Site Number 840019
  • Investigational Site Number 840039
  • Investigational Site Number 840042
  • Investigational Site Number 840043
  • Investigational Site Number 840028
  • Investigational Site Number 840034
  • Investigational Site Number 840026
  • Investigational Site Number 840022
  • Investigational Site Number 840029
  • Investigational Site Number 840009
  • Investigational Site Number 840051
  • Investigational Site Number 840050
  • Investigational Site Number 840031
  • Investigational Site Number 840004
  • Investigational Site Number 840010
  • Investigational Site Number 840038
  • Investigational Site Number 840030
  • Investigational Site Number 840012
  • Investigational Site Number 840044
  • Investigational Site Number 840015
  • Investigational Site Number 840008
  • Investigational Site Number 840027
  • Investigational Site Number 840011
  • Investigational Site Number 840005
  • Investigational Site Number 840052
  • Investigational Site Number 840049
  • Investigational Site Number 840006
  • Investigational Site Number 840035
  • Investigational Site Number 840016
  • Investigational Site Number 840020
  • Investigational Site Number 840024
  • Investigational Site Number 840001
  • Investigational Site Number 840007
  • Investigational Site Number 840013
  • Investigational Site Number 840014
  • Investigational Site Number 840046
  • Investigational Site Number 040-006
  • Investigational Site Number 040-007
  • Investigational Site Number 040-003
  • Investigational Site Number 040-005
  • Investigational Site Number 040-002
  • Investigational Site Number 040-001
  • Investigational Site Number 040-004
  • Investigational Site Number 076-004
  • Investigational Site Number 076-007
  • Investigational Site Number 076-001
  • Investigational Site Number 076-006
  • Investigational Site Number 076-005
  • Investigational Site Number 076-002
  • Investigational Site Number 124-003
  • Investigational Site Number 124-001
  • Investigational Site Number 124-006
  • Investigational Site Number 124-004
  • Investigational Site Number 124-008
  • Investigational Site Number 124-007
  • Investigational Site Number 203001
  • Investigational Site Number 203003
  • Investigational Site Number 203005
  • Investigational Site Number 203002
  • Investigational Site Number 203006
  • Investigational Site Number 246003
  • Investigational Site Number 246001
  • Investigational Site Number 246002
  • Investigational Site Number 246004
  • Investigational Site Number 250-007
  • Investigational Site Number 250-017
  • Investigational Site Number 250-003
  • Investigational Site Number 250-011
  • Investigational Site Number 250-008
  • Investigational Site Number 250-012
  • Investigational Site Number 250-009
  • Investigational Site Number 250-004
  • Investigational Site Number 250-006
  • Investigational Site Number 250-021
  • Investigational Site Number 250022
  • Investigational Site Number 250-020
  • Investigational Site Number 250-002
  • Investigational Site Number 250-016
  • Investigational Site Number 300003
  • Investigational Site Number 300004
  • Investigational Site Number 300001
  • Investigational Site Number 372001
  • Investigational Site Number 376004
  • Investigational Site Number 376002
  • Investigational Site Number 376003
  • Investigational Site Number 484004
  • Investigational Site Number 484001
  • Investigational Site Number 484002
  • Investigational Site Number 484003
  • Investigational Site Number 528001
  • Investigational Site Number 528006
  • Investigational Site Number 528002
  • Investigational Site Number 528007
  • Investigational Site Number 528003
  • Investigational Site Number 528004
  • Investigational Site Number 528005
  • Investigational Site Number 643-009
  • Investigational Site Number 643008
  • Investigational Site Number 643001
  • Investigational Site Number 643006
  • Investigational Site Number 643007
  • Investigational Site Number 643005
  • Investigational Site Number 643004
  • Investigational Site Number 643003
  • Investigational Site Number 703002
  • Investigational Site Number 703004
  • Investigational Site Number 703001
  • Investigational Site Number 703005
  • Investigational Site Number 703003
  • Investigational Site Number 724007
  • Investigational Site Number 724006
  • Investigational Site Number 724001
  • Investigational Site Number 724005
  • Investigational Site Number 724008
  • Investigational Site Number 724003
  • Investigational Site Number 724009
  • Investigational Site Number 721002
  • Investigational Site Number 724004
  • Investigational Site Number 724010
  • Investigational Site Number 752-002
  • Investigational Site Number 752-005
  • Investigational Site Number 752-006
  • Investigational Site Number 752-001
  • Investigational Site Number 752-03
  • Investigational Site Number 752-007
  • Investigational Site Number 792-001
  • Investigational Site Number 792-002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Glargine

Liraglutide

Arm Description

Insulin glargine administered once a day, in the morning or in the evening, at the most convenient time. The time of injection, once chosen was to remain unchanged during the whole duration of the study. The starting dose was 0.2 Unit per kilogram of body weight or 10 Units. Patients were empowered to adjust their insulin doses, under strict investigator's supervision. Insulin titration (by 2 or 4 Units) was done every 3 days according to the median value of Fasting Plasma Glucose (FPG) of the last 3 days. The goal was to achieve 70 < FPG ≤ 100 mg/dL (3.9 < FPG ≤ 5.5 mmol/L). Minor deviations from the titration scheme could be allowed, based on Investigator's judgment and patient's situation.

Liraglutide administered once a day, in the morning or in the evening, at the most convenient time. The time of injection , once chosen was to remain unchanged during the whole duration of the study. The dose was 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24. The dose might be decreased to 1.2 mg for safety reasons (e.g. gastro-intestinal tolerability), based on Investigator's judgment.

Outcomes

Primary Outcome Measures

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period
The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward [LOCF] value).

Secondary Outcome Measures

Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period
Percentage of patients with: * HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value AND * HbA1c value at end of the comparative period (LOCF) ≥7%
Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period
Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value
Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period
Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value
Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period
Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value
Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period
Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)
Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period
SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value) Change = LOCF value - baseline value
Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period
SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value) Change = LOCF value - week 24 value
Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period
Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value) Change = LOCF value - baseline value
Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period
Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value) Change = LOCF value - week 24 value
Body Weight: Change From Baseline to the End of the Comparative Period
Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline
Body Weight: Change From Beginning to End of the Extension Period
Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)
Daily Dose of Insulin Glargine
Daily Dose of Liraglutide
Daily Dose of Insulin Glargine Administered During the Extension Period
Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia. Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria: The event was associated with a measured PG level < 36 mg/dL (2 mmol/L), Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.
Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia. Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria: The event was associated with a measured PG level < 36 mg/dL (2 mmol/L), Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.

Full Information

First Posted
May 4, 2010
Last Updated
March 5, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01117350
Brief Title
Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
Acronym
EAGLE
Official Title
A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the comparative period (24 weeks): >To assess the effect of insulin glargine in comparison with liraglutide on: HbA1c level Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the comparative period Percentage of patients whose HbA1c has increased at the end of the comparative period Fasting Plasma Glucose (FPG) 7-point Plasma Glucose (PG) profiles Hypoglycemia occurrence Body weight Adverse events Objectives of the extension period (24 weeks): >To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on: HbA1c level FPG 7-point PG profiles Hypoglycemia occurrence Body weight Adverse events
Detailed Description
Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow: A 2-week of screening period, A 24-week comparative period, A 24-week extension period (only for patients treated with liraglutide, not adequately controlled at the end of the comparative period), A 1-week follow-up period

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
978 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Glargine
Arm Type
Experimental
Arm Description
Insulin glargine administered once a day, in the morning or in the evening, at the most convenient time. The time of injection, once chosen was to remain unchanged during the whole duration of the study. The starting dose was 0.2 Unit per kilogram of body weight or 10 Units. Patients were empowered to adjust their insulin doses, under strict investigator's supervision. Insulin titration (by 2 or 4 Units) was done every 3 days according to the median value of Fasting Plasma Glucose (FPG) of the last 3 days. The goal was to achieve 70 < FPG ≤ 100 mg/dL (3.9 < FPG ≤ 5.5 mmol/L). Minor deviations from the titration scheme could be allowed, based on Investigator's judgment and patient's situation.
Arm Title
Liraglutide
Arm Type
Active Comparator
Arm Description
Liraglutide administered once a day, in the morning or in the evening, at the most convenient time. The time of injection , once chosen was to remain unchanged during the whole duration of the study. The dose was 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24. The dose might be decreased to 1.2 mg for safety reasons (e.g. gastro-intestinal tolerability), based on Investigator's judgment.
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Other Intervention Name(s)
Lantus®
Intervention Description
100 Units/mL solution for injection in a pre-filled SoloStar pen
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza®
Intervention Description
6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg)
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin was a background treatment, mandatory for each patient randomized in the study (at the minimum dose of 1g/day). It was not supplied by the sponsor.
Primary Outcome Measure Information:
Title
Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period
Description
The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward [LOCF] value).
Time Frame
week 12, week 24
Secondary Outcome Measure Information:
Title
Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period
Description
Percentage of patients with: * HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value AND * HbA1c value at end of the comparative period (LOCF) ≥7%
Time Frame
baseline (week -2), week 12, week 24
Title
Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period
Description
Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value
Time Frame
baseline (week -2), week 12, week 24
Title
Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period
Description
Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value
Time Frame
baseline (week -2), week 12, week 24
Title
Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period
Description
Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value
Time Frame
week 24, week 36, week 48
Title
Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period
Description
Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)
Time Frame
week 36, week 48
Title
Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period
Description
SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value) Change = LOCF value - baseline value
Time Frame
baseline (week 0), week 6, week 12, week 18, week 24
Title
Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period
Description
SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value) Change = LOCF value - week 24 value
Time Frame
week 24, week 30, week 36, week 48
Title
Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period
Description
Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value) Change = LOCF value - baseline value
Time Frame
baseline (week 0), week 12, week 24
Title
Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period
Description
Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value) Change = LOCF value - week 24 value
Time Frame
week 24, week 36, week 48
Title
Body Weight: Change From Baseline to the End of the Comparative Period
Description
Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline
Time Frame
baseline (week 0), week 2, week 6, week 12, week 18, week 24
Title
Body Weight: Change From Beginning to End of the Extension Period
Description
Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)
Time Frame
week 24, week 30, week 36, week 48
Title
Daily Dose of Insulin Glargine
Time Frame
week 1, week 2, week 6, week 12, week 24
Title
Daily Dose of Liraglutide
Time Frame
week 1, week 2, week 6, week 12, week 24
Title
Daily Dose of Insulin Glargine Administered During the Extension Period
Time Frame
week 30, week 36, week 48
Title
Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period
Description
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia. Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria: The event was associated with a measured PG level < 36 mg/dL (2 mmol/L), Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.
Time Frame
all across the comparative period (from week 0 to week 24)
Title
Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period
Description
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia. Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria: The event was associated with a measured PG level < 36 mg/dL (2 mmol/L), Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration.
Time Frame
all across the extension period (from week 24 to week 48)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria (comparative period): Patients With Type 2 Diabetes diagnosed for at least 1 year, Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months, 7.5% < HbA1c <= 12%, Body Mass Index (BMI) between 25 and 40 kg/m2 inclusively, Ability and willingness to perform PG (Plasma Glucose) self monitoring using the sponsor-provided glucose meter and to complete the patient diary, Willingness and ability to comply with the study protocol, Signed informed consent obtained prior to any study procedure. Inclusion criteria (extension period): Patients treated with liraglutide (at the maximal tolerated dosage), having a mean FPG ≥ 250 mg/dL at visit 10 (Week 12) or visit 11 (Week 18), or a HbA1c≥ 7% at visit 12 (Week 24) Dosage of metformin compliant with the inclusion criteria of visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period. Exclusion criteria: Previous treatment with Glucagon Like Peptide-1 analogues or insulin in the past year (except in case of temporary treatment for gestational diabetes, surgery, hospitalization...), Treatment with thiazolidinediones or α-Glucosidases inhibitors within 3 months prior to study entry, Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake), Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method), Lactating women, Hospitalized patients (except hospitalization for routine diabetes check-up), Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry, Impaired renal function (creatinine clearance < 60 mL/mn), Impaired hepatic function (Alanine Aminotransferase, Aspartate Aminotransferase 2.5 times the upper limit of normal range), Personal or family history of medullary thyroid carcinoma, Multiple endocrine neoplasia syndrome type 2, Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis), Congestive heart failure, History of acute pancreatitis, Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry, Alcohol or drug abuse in the past 5 years, History of sensitivity to the study drugs or to drugs with a similar chemical structure. Night shift worker, Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patients safety or limit the patient successful participation in the study, Participation in a clinical trial (drug or device) within 3 months prior to study entry, Refusal or inability to give informed consent to participate in the study, Patient is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. Additional exclusion criteria for the extension period: Treatment with oral antidiabetic drugs other than metformin and patient's usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days), Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period. History of sensitivity to insulin glargine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840023
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Investigational Site Number 840002
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Investigational Site Number 840047
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Investigational Site Number 840017
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840036
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Investigational Site Number 840037
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
Investigational Site Number 840045
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Investigational Site Number 840048
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Investigational Site Number 840033
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Investigational Site Number 840019
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Investigational Site Number 840039
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Investigational Site Number 840042
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Investigational Site Number 840043
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Investigational Site Number 840028
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Investigational Site Number 840034
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Investigational Site Number 840026
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Investigational Site Number 840022
City
Lawrenceville
State/Province
Georgia
Country
United States
Facility Name
Investigational Site Number 840029
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Investigational Site Number 840009
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Investigational Site Number 840051
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Investigational Site Number 840050
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
Facility Name
Investigational Site Number 840031
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Investigational Site Number 840004
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Investigational Site Number 840010
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Investigational Site Number 840038
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55122
Country
United States
Facility Name
Investigational Site Number 840030
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Investigational Site Number 840012
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Investigational Site Number 840044
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigational Site Number 840015
City
Atco
State/Province
New Jersey
ZIP/Postal Code
08004
Country
United States
Facility Name
Investigational Site Number 840008
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
Investigational Site Number 840027
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Investigational Site Number 840011
City
Staten Island
State/Province
New York
ZIP/Postal Code
10301-3914
Country
United States
Facility Name
Investigational Site Number 840005
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Investigational Site Number 840052
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site Number 840049
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Investigational Site Number 840006
City
Bryan
State/Province
Ohio
ZIP/Postal Code
43506
Country
United States
Facility Name
Investigational Site Number 840035
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Investigational Site Number 840016
City
Carnegie
State/Province
Pennsylvania
ZIP/Postal Code
15106
Country
United States
Facility Name
Investigational Site Number 840020
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Investigational Site Number 840024
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Investigational Site Number 840001
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840007
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Site Number 840013
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number 840014
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Investigational Site Number 840046
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220-3649
Country
United States
Facility Name
Investigational Site Number 040-006
City
Salzburg
ZIP/Postal Code
5010
Country
Austria
Facility Name
Investigational Site Number 040-007
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Investigational Site Number 040-003
City
Stockerau
ZIP/Postal Code
A-2000
Country
Austria
Facility Name
Investigational Site Number 040-005
City
Vienna
ZIP/Postal Code
A-1010
Country
Austria
Facility Name
Investigational Site Number 040-002
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Investigational Site Number 040-001
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
Investigational Site Number 040-004
City
Vienna
ZIP/Postal Code
A-1220
Country
Austria
Facility Name
Investigational Site Number 076-004
City
Belém
ZIP/Postal Code
66073-000
Country
Brazil
Facility Name
Investigational Site Number 076-007
City
Fortaleza
ZIP/Postal Code
60015-052
Country
Brazil
Facility Name
Investigational Site Number 076-001
City
Fortaleza
ZIP/Postal Code
60115-282
Country
Brazil
Facility Name
Investigational Site Number 076-006
City
Fortaleza
ZIP/Postal Code
60430-370
Country
Brazil
Facility Name
Investigational Site Number 076-005
City
Marília
ZIP/Postal Code
17519-101
Country
Brazil
Facility Name
Investigational Site Number 076-002
City
São Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Investigational Site Number 124-003
City
Mississauga
ZIP/Postal Code
L5M2V8
Country
Canada
Facility Name
Investigational Site Number 124-001
City
Montreal
ZIP/Postal Code
H2W1T8
Country
Canada
Facility Name
Investigational Site Number 124-006
City
Montreal
ZIP/Postal Code
H3A1A1
Country
Canada
Facility Name
Investigational Site Number 124-004
City
Toronto
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Investigational Site Number 124-008
City
Vancouver
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
Investigational Site Number 124-007
City
Victoria
ZIP/Postal Code
V8R1J8
Country
Canada
Facility Name
Investigational Site Number 203001
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Investigational Site Number 203003
City
Krnov
ZIP/Postal Code
79401
Country
Czech Republic
Facility Name
Investigational Site Number 203005
City
Kromeriz
ZIP/Postal Code
76701
Country
Czech Republic
Facility Name
Investigational Site Number 203002
City
Olomouc
ZIP/Postal Code
77900
Country
Czech Republic
Facility Name
Investigational Site Number 203006
City
Praha 5
ZIP/Postal Code
15000
Country
Czech Republic
Facility Name
Investigational Site Number 246003
City
Harjavalta
ZIP/Postal Code
29200
Country
Finland
Facility Name
Investigational Site Number 246001
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Investigational Site Number 246002
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Investigational Site Number 246004
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Investigational Site Number 250-007
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
Investigational Site Number 250-017
City
Bois Guillaume Cedex
ZIP/Postal Code
76233
Country
France
Facility Name
Investigational Site Number 250-003
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Investigational Site Number 250-011
City
Brest
ZIP/Postal Code
29000
Country
France
Facility Name
Investigational Site Number 250-008
City
Cahors Cedex 9
ZIP/Postal Code
46005
Country
France
Facility Name
Investigational Site Number 250-012
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Investigational Site Number 250-009
City
La Rochelle Cedex 1
ZIP/Postal Code
17019
Country
France
Facility Name
Investigational Site Number 250-004
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Investigational Site Number 250-006
City
Mantes La Jolie
ZIP/Postal Code
78200
Country
France
Facility Name
Investigational Site Number 250-021
City
Nanterre
ZIP/Postal Code
92014
Country
France
Facility Name
Investigational Site Number 250022
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Investigational Site Number 250-020
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Investigational Site Number 250-002
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Investigational Site Number 250-016
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Investigational Site Number 300003
City
Athens
Country
Greece
Facility Name
Investigational Site Number 300004
City
Athens
Country
Greece
Facility Name
Investigational Site Number 300001
City
Haidari, Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Investigational Site Number 372001
City
Dublin 4
Country
Ireland
Facility Name
Investigational Site Number 376004
City
Hadera
Country
Israel
Facility Name
Investigational Site Number 376002
City
Petah Tiqwa
ZIP/Postal Code
49361
Country
Israel
Facility Name
Investigational Site Number 376003
City
Tel-Aviv
Country
Israel
Facility Name
Investigational Site Number 484004
City
Guadalajara
ZIP/Postal Code
44630
Country
Mexico
Facility Name
Investigational Site Number 484001
City
Mexico
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Investigational Site Number 484002
City
Mexico
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Investigational Site Number 484003
City
Zapopan
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Investigational Site Number 528001
City
Beek
ZIP/Postal Code
6191JW
Country
Netherlands
Facility Name
Investigational Site Number 528006
City
Enschede
ZIP/Postal Code
7523JJ
Country
Netherlands
Facility Name
Investigational Site Number 528002
City
Hoogeveen
ZIP/Postal Code
7909AA
Country
Netherlands
Facility Name
Investigational Site Number 528007
City
Nijverdal
ZIP/Postal Code
7442LS
Country
Netherlands
Facility Name
Investigational Site Number 528003
City
Rotterdam
Country
Netherlands
Facility Name
Investigational Site Number 528004
City
s-Hertogenbosch
Country
Netherlands
Facility Name
Investigational Site Number 528005
City
Woerden
Country
Netherlands
Facility Name
Investigational Site Number 643-009
City
Kazan
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
Kirov
ZIP/Postal Code
610014K
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Investigational Site Number 643006
City
Samara
Country
Russian Federation
Facility Name
Investigational Site Number 643007
City
Samara
Country
Russian Federation
Facility Name
Investigational Site Number 643005
City
Saratov
Country
Russian Federation
Facility Name
Investigational Site Number 643004
City
St-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Investigational Site Number 643003
City
St-Ptetersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number 703002
City
Bratislava
ZIP/Postal Code
81102
Country
Slovakia
Facility Name
Investigational Site Number 703004
City
Kosice
ZIP/Postal Code
04013
Country
Slovakia
Facility Name
Investigational Site Number 703001
City
Nitra
ZIP/Postal Code
94911
Country
Slovakia
Facility Name
Investigational Site Number 703005
City
Nove Mesto nad Vahom
ZIP/Postal Code
091501
Country
Slovakia
Facility Name
Investigational Site Number 703003
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia
Facility Name
Investigational Site Number 724007
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Investigational Site Number 724006
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Investigational Site Number 724001
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35020
Country
Spain
Facility Name
Investigational Site Number 724005
City
LLeida
Country
Spain
Facility Name
Investigational Site Number 724008
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 724003
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 724009
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigational Site Number 721002
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Investigational Site Number 724004
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Investigational Site Number 724010
City
Vigo
ZIP/Postal Code
36211
Country
Spain
Facility Name
Investigational Site Number 752-002
City
Göteborg
ZIP/Postal Code
41665
Country
Sweden
Facility Name
Investigational Site Number 752-005
City
Karlskoga
ZIP/Postal Code
69181
Country
Sweden
Facility Name
Investigational Site Number 752-006
City
Motala
ZIP/Postal Code
59185
Country
Sweden
Facility Name
Investigational Site Number 752-001
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Investigational Site Number 752-03
City
Ängelholm
ZIP/Postal Code
26281
Country
Sweden
Facility Name
Investigational Site Number 752-007
City
Örebro
ZIP/Postal Code
70235
Country
Sweden
Facility Name
Investigational Site Number 792-001
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Investigational Site Number 792-002
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey

12. IPD Sharing Statement

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Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

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