Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients (GetGoal-O)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01798706
First received: February 22, 2013
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

Primary objective:

- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by HbA1c reduction, in older type 2 diabetes patients (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen.

Main secondary objective:

- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM patients (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects).

Other secondary objectives:

  • To assess the effect of lixisenatide compared to placebo after 24-week treatment on:

    • Fasting plasma glucose (FPG)
    • During liquid standardized breakfast meal challenge test : 2 hour- PPG and Plasma Glucose Excursion
    • 7-point Self-monitored plasma glucose (SMPG) profile
    • Body weight
    • Change in total daily dose of basal insulin (if taken)
    • Percentage of patients requiring rescue therapy
    • Safety and tolerability
  • To assess lixisenatide pharmacokinetic profile
  • To assess anti-lixisenatide antibody development.

Condition Intervention Phase
Type 2 Diabetes
Drug: lixisenatide (AVE0010)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting Plasma Glucose (FPG) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in 2-hour PPG and plasma glucose excursions (2-hour postprandial plasma glucose - FPG) during the liquid standardized breakfast meal test from baseline [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in 7-point Self-Monitored plasma glucose (SMPG) profile (i.e, the average and each time point of the 7 points) from baseline [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in total daily basal insulin dose from baseline for patients taking basal insulin [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients requiring rescue therapy during the 24-week double-blind treatment period [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year) [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]
  • Severe hypoglycemia [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]
  • Gastrointestinal side effects [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 340
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lixisenatide
lixisenatide selfinjected subcutaneously once a day before breakfast on top of basal insulin and/or other allowed oral antidiabetic therapy. Starting dose will be 10μg, then increased to the 20μg maintenance dose after 2 weeks.
Drug: lixisenatide (AVE0010)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Placebo Comparator: placebo
Placebo of lixisenatide selfinjected subcutaneously once a day before breakfast on top of basal insulin and/or other allowed oral antidiabetic therapy.
Drug: placebo

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection


Detailed Description:

Approximately 31 weeks including 24 week treatment period

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Older patients, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic pharmaceutical treatment regimen
  • Signed written informed consent

Exclusion criteria:

  • At screening HbA1c ≤7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older patients and that this is the responsibility of the investigator to include the patient based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia)
  • At screening patients on both basal insulin and sulfonylurea or basal insulin and meglitinides
  • At screening FPG >250 mg/dL (>13.9 mmol/L)
  • Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit.
  • Type 2 diabetes mellitus diagnosed less than 1 year prior to screening
  • Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening
  • Treatment within the 3 months preceding the screening with other antidiabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea [except glibenclamide >10mg, glicazide >160mg], meglitinides [except repaglinide >6mg], pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population. .
  • Patients who have been on an approved or an investigational GLP-1 medication (exenatide, liraglutide, lixisenatide or others)
  • History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening
  • BMI <22 or >40 kg/m²
  • Malnutrition assessed clinically by the investigator or any sub-investigator and by MNA-SF score <12 in countries (the judgment of the investigator prevails on questionnaires scores)
  • Cognitive disorder and dementia assessed clinically by the investigator or any sub investigator and by MMSE score <24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that will affect the patient's ability to participate in the study
  • Patient who have an eGFR (using the Modification of Diet in Renal Disease {MDRD} formula <30ml/min/1.73m2
  • Patients with severe or uncontrolled disease, or any clinically significant abnormality identified on physical examination or investigational clinical procedure that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrains efficacy assessment
  • Laboratory findings at the time of screening:

    • Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range
    • ALT or AST >3 times ULN
    • Calcitonin >20 pg/mL (5.9 pmol/L)
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) and not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
  • Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposes to medullary thyroid cancer (eg, multiple endocrine neoplasia syndromes)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  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: NCT01798706

  Hide Study Locations
Locations
United States, California
Investigational Site Number 840010
La Jolla, California, United States, 92037
Investigational Site Number 840015
Norwalk, California, United States, 90650
United States, Florida
Investigational Site Number 840003
Miami, Florida, United States, 33156
Investigational Site Number 840012
Miami, Florida, United States, 33156
United States, Iowa
Investigational Site Number 840002
Des Moines, Iowa, United States, 50314
United States, Maryland
Investigational Site Number 840008
Oxon Hill, Maryland, United States, 20745
Investigational Site Number 840004
Rockville, Maryland, United States, 20852
United States, Mississippi
Investigational Site Number 840017
Biloxi, Mississippi, United States, 39531
United States, Nebraska
Investigational Site Number 840009
Omaha, Nebraska, United States, 68131
United States, North Carolina
Investigational Site Number 840016
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Investigational Site Number 840006
Fargo, North Dakota, United States, 58103
United States, Ohio
Investigational Site Number 840014
Canal Fulton, Ohio, United States, 44614
United States, Utah
Investigational Site Number 840011
St. George, Utah, United States, 84790
United States, Wisconsin
Investigational Site Number 840007
Milwaukee, Wisconsin, United States, 53209
Australia
Investigational Site Number 036002
Box Hill, Australia, 3128
Investigational Site Number 036006
Brookvale, Australia, 2100
Investigational Site Number 036004
Camperdown, Australia, 2050
Investigational Site Number 036005
Gosford, Australia, 2250
Investigational Site Number 036001
Heidelberg, Australia, 3081
Investigational Site Number 036003
Parkville, Australia, 3050
Bulgaria
Investigational Site Number 100002
Plovdiv, Bulgaria, 4002
Investigational Site Number 100005
Plovdiv, Bulgaria, 4002
Investigational Site Number 100003
Sofia, Bulgaria, 1632
Investigational Site Number 100004
Stara Zagora, Bulgaria, 6000
Investigational Site Number 100001
Varna, Bulgaria, 9000
Canada
Investigational Site Number 124003
Hamilton, Canada, L8L 5G8
Investigational Site Number 124007
London, Canada, N6B 2E3
Investigational Site Number 124002
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 124001
St-Romuald, Canada, G6W 5M6
Investigational Site Number 124005
Vancouver, Canada, V5Z 1M9
Investigational Site Number 124006
Vancouver, Canada, V5Z 1M9
Investigational Site Number 124008
Westmount, Canada, H3Z 1E5
Investigational Site Number 124004
Winnipeg, Canada, R3E 3P4
Denmark
Investigational Site Number 208005
Esbjerg, Denmark, 6700
Investigational Site Number 208001
København Nv, Denmark, 2400
Investigational Site Number 208004
København S, Denmark, 2300
Investigational Site Number 208002
Slagelse, Denmark, 4200
Investigational Site Number 208003
Svendborg, Denmark, 5700
Germany
Investigational Site Number 276005
Dresden, Germany, 01307
Investigational Site Number 276004
Essen, Germany, 45359
Investigational Site Number 276002
München, Germany, 80639
Investigational Site Number 276001
Münster, Germany, 48145
Investigational Site Number 276006
Pirna, Germany, 01796
Investigational Site Number 276007
Pohlheim, Germany, 35415
Investigational Site Number 276008
Potsdam, Germany, 14469
Investigational Site Number 276003
Saarlouis, Germany, 66740
Norway
Investigational Site Number 578001
Hønefoss, Norway, 3515
Investigational Site Number 578005
Kongsvinger, Norway, 2212
Investigational Site Number 578003
Oslo, Norway
Investigational Site Number 578006
Stavanger, Norway, 4095
Investigational Site Number 578004
Trondheim, Norway, 7012
Peru
Investigational Site Number 604001
Arequipa, Peru
Investigational Site Number 604002
Lima, Peru
Investigational Site Number 604003
Lima, Peru, LIMA 14
Investigational Site Number 604005
Lima, Peru, LIMA 10
Investigational Site Number 604006
Lima, Peru, LIMA 31
Investigational Site Number 604007
Lima, Peru
Investigational Site Number 604011
Lima, Peru, 27
Investigational Site Number 604008
Piura, Peru
Poland
Investigational Site Number 616004
Gdansk, Poland, 80-858
Investigational Site Number 616003
Krakow, Poland, 31-024
Investigational Site Number 616001
Poznan, Poland, 61-665
Investigational Site Number 616002
Ruda Slaska, Poland, 41-709
Investigational Site Number 616006
Szczecin, Poland, 70-506
South Africa
Investigational Site Number 710002
Cape Town, South Africa, 7530
Investigational Site Number 710003
Cape Town, South Africa, 7500
Investigational Site Number 710004
Somerset West, South Africa, 7130
Spain
Investigational Site Number 724001
Alcira, Spain, 46600
Investigational Site Number 724005
Barcelona, Spain, 08035
Investigational Site Number 724006
Hostalets De Balenyà, Spain, 08550
Investigational Site Number 724003
Madrid, Spain, 28046
Investigational Site Number 724002
Sanlúcar De Barrameda, Spain, 11540
Investigational Site Number 724004
Santiago De Compostela, Spain, 15706
Sweden
Investigational Site Number 752006
Göteborg, Sweden, 405 45
Investigational Site Number 752007
Härnösand, Sweden, 871 82
Investigational Site Number 752002
Lund, Sweden, 22221
Investigational Site Number 752004
Malmö, Sweden, 211 52
Investigational Site Number 752001
Stockholm, Sweden, 171 76
Investigational Site Number 752003
Stockholm, Sweden, 111 57
United Kingdom
Investigational Site Number 826003
Bexhill-On-Sea, United Kingdom, TN39 4SP
Investigational Site Number 826001
Glasgow, United Kingdom
Investigational Site Number 826002
Irvine, United Kingdom, KA12 0AY
Investigational Site Number 826004
Trowbridge, United Kingdom, BA14 8QA
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01798706     History of Changes
Other Study ID Numbers: EFC12703, 2012-003292-19, U1111-1132-9156
Study First Received: February 22, 2013
Last Updated: March 25, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 30, 2015