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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01117350
First received: May 4, 2010
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin glargine
Drug: Liraglutide
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period [ Time Frame: week 12, week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline (week -2), week 12, week 24 ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline (week -2), week 12, week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline (week -2), week 12, week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 24, week 36, week 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 36, week 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline (week 0), week 6, week 12, week 18, week 24 ] [ Designated as safety issue: No ]

    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 [ Time Frame: week 24, week 30, week 36, week 48 ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline (week 0), week 12, week 24 ] [ Designated as safety issue: No ]

    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 [ Time Frame: week 24, week 36, week 48 ] [ Designated as safety issue: No ]

    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 [ Time Frame: baseline (week 0), week 2, week 6, week 12, week 18, week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 24, week 30, week 36, week 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 1, week 2, week 6, week 12, week 24 ] [ Designated as safety issue: No ]
  • Daily Dose of Liraglutide [ Time Frame: week 1, week 2, week 6, week 12, week 24 ] [ Designated as safety issue: No ]
  • Daily Dose of Insulin Glargine Administered During the Extension Period [ Time Frame: week 30, week 36, week 48 ] [ Designated as safety issue: No ]
  • Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period [ Time Frame: all across the comparative period (from week 0 to week 24) ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: all across the extension period (from week 24 to week 48) ] [ Designated as safety issue: Yes ]

    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.


Enrollment: 978
Study Start Date: July 2010
Study Completion Date: March 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: Liraglutide
6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg)
Other Name: Victoza®
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.

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
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117350

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01117350     History of Changes
Other Study ID Numbers: LANTU_C_03680, 2010-018437-21, U1111-1116-9684
Study First Received: May 4, 2010
Results First Received: October 4, 2013
Last Updated: March 5, 2014
Health Authority: Czech Republic: State Institute for Drug Control
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Liraglutide
Metformin
Insulin
Insulin, Long-Acting
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014