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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin glargine; Drug: Metformin; Drug: Liraglutide

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

• Study Type: Interventional
• Enrollment (Actual): 978
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5010
    • Investigational Site Number 040-006
  • Salzburg, Austria, 5020
    • Investigational Site Number 040-007
  • Stockerau, Austria, A-2000
    • Investigational Site Number 040-003
  • Vienna, Austria, A-1010
    • Investigational Site Number 040-005
  • Vienna, Austria, A-1090
    • Investigational Site Number 040-002
  • Vienna, Austria, A-1130
    • Investigational Site Number 040-001
  • Vienna, Austria, A-1220
    • Investigational Site Number 040-004
• Brazil
  • Belém, Brazil, 66073-000
    • Investigational Site Number 076-004
  • Fortaleza, Brazil, 60115-282
    • Investigational Site Number 076-001
  • Fortaleza, Brazil, 60015-052
    • Investigational Site Number 076-007
  • Fortaleza, Brazil, 60430-370
    • Investigational Site Number 076-006
  • Marília, Brazil, 17519-101
    • Investigational Site Number 076-005
  • São Paulo, Brazil, 01244-030
    • Investigational Site Number 076-002
• Canada
  • Mississauga, Canada, L5M2V8
    • Investigational Site Number 124-003
  • Montreal, Canada, H2W1T8
    • Investigational Site Number 124-001
  • Montreal, Canada, H3A1A1
    • Investigational Site Number 124-006
  • Toronto, Canada, M5C 2T2
    • Investigational Site Number 124-004
  • Vancouver, Canada, V5Z1M9
    • Investigational Site Number 124-008
  • Victoria, Canada, V8R1J8
    • Investigational Site Number 124-007
• Czech Republic
  • Hradec Kralove, Czech Republic, 50005
    • Investigational Site Number 203001
  • Krnov, Czech Republic, 79401
    • Investigational Site Number 203003
  • Kromeriz, Czech Republic, 76701
    • Investigational Site Number 203005
  • Olomouc, Czech Republic, 77900
    • Investigational Site Number 203002
  • Praha 5, Czech Republic, 15000
    • Investigational Site Number 203006
• Finland
  • Harjavalta, Finland, 29200
    • Investigational Site Number 246003
  • Kuopio, Finland, 70210
    • Investigational Site Number 246001
  • Oulu, Finland, 90100
    • Investigational Site Number 246002
  • Turku, Finland, 20100
    • Investigational Site Number 246004
• France
  • Annecy, France, 74000
    • Investigational Site Number 250-007
  • Bois Guillaume Cedex, France, 76233
    • Investigational Site Number 250-017
  • Boulogne Billancourt, France, 92100
    • Investigational Site Number 250-003
  • Brest, France, 29000
    • Investigational Site Number 250-011
  • Cahors Cedex 9, France, 46005
    • Investigational Site Number 250-008
  • Corbeil Essonnes, France, 91100
    • Investigational Site Number 250-012
  • La Rochelle Cedex 1, France, 17019
    • Investigational Site Number 250-009
  • Le Creusot, France, 71200
    • Investigational Site Number 250-004
  • Mantes La Jolie, France, 78200
    • Investigational Site Number 250-006
  • Nanterre, France, 92014
    • Investigational Site Number 250-021
  • Strasbourg, France, 67000
    • Investigational Site Number 250022
  • Strasbourg, France, 67091
    • Investigational Site Number 250-020
  • Toulouse, France, 31300
    • Investigational Site Number 250-002
  • Venissieux, France, 69200
    • Investigational Site Number 250-016
• Greece
  • Athens, Greece
    • Investigational Site Number 300003
  • Athens, Greece
    • Investigational Site Number 300004
  • Haidari, Athens, Greece, 12462
    • Investigational Site Number 300001
• Ireland
  • Dublin 4, Ireland
    • Investigational Site Number 372001
• Israel
  • Hadera, Israel
    • Investigational Site Number 376004
  • Petah Tiqwa, Israel, 49361
    • Investigational Site Number 376002
  • Tel-Aviv, Israel
    • Investigational Site Number 376003
• Mexico
  • Guadalajara, Mexico, 44630
    • Investigational Site Number 484004
  • Mexico, Mexico, 07760
    • Investigational Site Number 484001
  • Mexico, Mexico, 14000
    • Investigational Site Number 484002
  • Zapopan, Mexico, 45200
    • Investigational Site Number 484003
• Netherlands
  • Beek, Netherlands, 6191JW
    • Investigational Site Number 528001
  • Enschede, Netherlands, 7523JJ
    • Investigational Site Number 528006
  • Hoogeveen, Netherlands, 7909AA
    • Investigational Site Number 528002
  • Nijverdal, Netherlands, 7442LS
    • Investigational Site Number 528007
  • Rotterdam, Netherlands
    • Investigational Site Number 528003
  • Woerden, Netherlands
    • Investigational Site Number 528005
  • s-Hertogenbosch, Netherlands
    • Investigational Site Number 528004
• Russian Federation
  • Kazan, Russian Federation
    • Investigational Site Number 643-009
  • Kirov, Russian Federation, 610014K
    • Investigational Site Number 643008
  • Moscow, Russian Federation, 117036
    • Investigational Site Number 643001
  • Samara, Russian Federation
    • Investigational Site Number 643006
  • Samara, Russian Federation
    • Investigational Site Number 643007
  • Saratov, Russian Federation
    • Investigational Site Number 643005
  • St-Petersburg, Russian Federation, 195257
    • Investigational Site Number 643004
  • St-Ptetersburg, Russian Federation, 194354
    • Investigational Site Number 643003
• Slovakia
  • Bratislava, Slovakia, 81102
    • Investigational Site Number 703002
  • Kosice, Slovakia, 04013
    • Investigational Site Number 703004
  • Nitra, Slovakia, 94911
    • Investigational Site Number 703001
  • Nove Mesto nad Vahom, Slovakia, 091501
    • Investigational Site Number 703005
  • Zilina, Slovakia, 01001
    • Investigational Site Number 703003
• Spain
  • Bilbao, Spain, 48013
    • Investigational Site Number 724007
  • Cádiz, Spain, 11009
    • Investigational Site Number 724006
  • LLeida, Spain
    • Investigational Site Number 724005
  • Las Palmas de Gran Canaria, Spain, 35020
    • Investigational Site Number 724001
  • Madrid, Spain, 28040
    • Investigational Site Number 724008
  • Málaga, Spain, 29010
    • Investigational Site Number 724003
  • Sabadell, Spain, 08208
    • Investigational Site Number 724009
  • Valencia, Spain, 46014
    • Investigational Site Number 721002
  • Valencia, Spain, 46015
    • Investigational Site Number 724004
  • Vigo, Spain, 36211
    • Investigational Site Number 724010
• Sweden
  • Göteborg, Sweden, 41665
    • Investigational Site Number 752-002
  • Karlskoga, Sweden, 69181
    • Investigational Site Number 752-005
  • Motala, Sweden, 59185
    • Investigational Site Number 752-006
  • Stockholm, Sweden, 17176
    • Investigational Site Number 752-001
  • Ängelholm, Sweden, 26281
    • Investigational Site Number 752-03
  • Örebro, Sweden, 70235
    • Investigational Site Number 752-007
• Turkey
  • Antalya, Turkey, 07070
    • Investigational Site Number 792-001
  • Istanbul, Turkey, 34890
    • Investigational Site Number 792-002
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Investigational Site Number 840023
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Investigational Site Number 840002
    • Phoenix, Arizona, United States, 85020
      • Investigational Site Number 840047
  • California
    • La Jolla, California, United States, 92037
      • Investigational Site Number 840017
    • La Mesa, California, United States, 91942
      • Investigational Site Number 840036
    • Loma Linda, California, United States, 92357
      • Investigational Site Number 840037
    • Long Beach, California, United States, 90822
      • Investigational Site Number 840045
    • Mission Hills, California, United States, 91345
      • Investigational Site Number 840048
    • Mission Viejo, California, United States, 92691
      • Investigational Site Number 840033
    • Palm Springs, California, United States, 92262
      • Investigational Site Number 840019
    • San Diego, California, United States, 92101
      • Investigational Site Number 840039
    • San Diego, California, United States, 92161
      • Investigational Site Number 840042
    • Tustin, California, United States, 92780
      • Investigational Site Number 840043
  • Colorado
    • Denver, Colorado, United States, 80220
      • Investigational Site Number 840028
    • Grand Junction, Colorado, United States, 81501
      • Investigational Site Number 840034
    • Longmont, Colorado, United States, 80501
      • Investigational Site Number 840026
  • Georgia
    • Lawrenceville, Georgia, United States
      • Investigational Site Number 840022
    • Roswell, Georgia, United States, 30076
      • Investigational Site Number 840029
  • Illinois
    • Arlington Heights, Illinois, United States, 60004
      • Investigational Site Number 840009
    • Springfield, Illinois, United States, 62704
      • Investigational Site Number 840051
  • Indiana
    • Indianapolis, Indiana, United States, 46222
      • Investigational Site Number 840050
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Investigational Site Number 840031
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Investigational Site Number 840004
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Investigational Site Number 840010
  • Minnesota
    • Eagan, Minnesota, United States, 55122
      • Investigational Site Number 840038
    • Minneapolis, Minnesota, United States, 55414
      • Investigational Site Number 840030
  • Missouri
    • St Louis, Missouri, United States, 63128
      • Investigational Site Number 840012
    • St. Louis, Missouri, United States, 63141
      • Investigational Site Number 840044
  • New Jersey
    • Atco, New Jersey, United States, 08004
      • Investigational Site Number 840015
    • Blackwood, New Jersey, United States, 08012
      • Investigational Site Number 840008
  • New York
    • Mineola, New York, United States, 11501
      • Investigational Site Number 840027
    • Staten Island, New York, United States, 10301-3914
      • Investigational Site Number 840011
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Investigational Site Number 840005
    • Winston-Salem, North Carolina, United States, 27103
      • Investigational Site Number 840052
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Investigational Site Number 840049
  • Ohio
    • Bryan, Ohio, United States, 43506
      • Investigational Site Number 840006
    • Cincinnati, Ohio, United States, 45220
      • Investigational Site Number 840035
  • Pennsylvania
    • Carnegie, Pennsylvania, United States, 15106
      • Investigational Site Number 840016
    • Uniontown, Pennsylvania, United States, 15401
      • Investigational Site Number 840020
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Investigational Site Number 840024
  • Texas
    • Dallas, Texas, United States, 75230
      • Investigational Site Number 840001
    • Dallas, Texas, United States, 75246
      • Investigational Site Number 840007
    • Houston, Texas, United States, 77030
      • Investigational Site Number 840013
  • Washington
    • Renton, Washington, United States, 98057
      • Investigational Site Number 840014
    • Spokane, Washington, United States, 99220-3649
      • Investigational Site Number 840046

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Insulin Glargine; 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.	Drug: Insulin glargine; 100 Units/mL solution for injection in a pre-filled SoloStar pen; Other Names: Lantus®; Drug: Metformin; 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.
ACTIVE_COMPARATOR: Liraglutide; 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.	Drug: Metformin; 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.; Drug: Liraglutide; 6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg); Other Names: Victoza®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	week 12, week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	baseline (week -2), week 12, week 24
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	baseline (week -2), week 12, week 24
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	baseline (week -2), week 12, week 24
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	week 24, week 36, week 48
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)	week 36, week 48
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	baseline (week 0), week 6, week 12, week 18, week 24
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	week 24, week 30, week 36, week 48
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	baseline (week 0), week 12, week 24
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	week 24, week 36, week 48
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	baseline (week 0), week 2, week 6, week 12, week 18, week 24
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)	week 24, week 30, week 36, week 48
Daily Dose of Insulin Glargine		week 1, week 2, week 6, week 12, week 24
Daily Dose of Liraglutide		week 1, week 2, week 6, week 12, week 24
Daily Dose of Insulin Glargine Administered During the Extension Period		week 30, week 36, week 48
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.	all across the comparative period (from week 0 to week 24)
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.	all across the extension period (from week 24 to week 48)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (ESTIMATE): May 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 11, 2014
• Last Update Submitted That Met QC Criteria: March 5, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; Metformin; Insulin Glargine
• Other Study ID Numbers: LANTU_C_03680; 2010-018437-21 (EUDRACT_NUMBER); U1111-1116-9684 (OTHER: UTN)