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 currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01798706
First received: February 22, 2013
Last updated: July 21, 2014
Last verified: July 2014

February 22, 2013
July 21, 2014
June 2013
March 2015   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01798706 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in 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 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
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

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.

Approximately 31 weeks including 24 week treatment period

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: lixisenatide (AVE0010)

    Pharmaceutical form:solution for injection (disposable self injector)

    Route of administration: subcutaneous injection

  • Drug: placebo

    Pharmaceutical form:solution for injection (disposable self injector)

    Route of administration: subcutaneous injection

  • 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.
    Intervention: Drug: lixisenatide (AVE0010)
  • 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.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
340
March 2015
March 2015   (final data collection date for primary outcome measure)

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.

Both
70 Years and older
No
Contact: For site information, send an email with site number to Contact-Us@sanofi.com
United States,   Australia,   Bulgaria,   Canada,   Denmark,   Germany,   Norway,   Peru,   Poland,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT01798706
EFC12703, 2012-003292-19, U1111-1132-9156
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP