Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients (GetGoal Duo-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01768559
First received: January 11, 2013
Last updated: July 16, 2014
Last verified: July 2014

January 11, 2013
July 16, 2014
January 2013
December 2014   (final data collection date for primary outcome measure)
  • Change from baseline in HbA1c [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01768559 on ClinicalTrials.gov Archive Site
  • Percentage of patients reaching HbA1c <7% [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c ≤6.5% [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Percentage of patients with no weight gain [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change in 7-point SMPG profiles from baseline [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in FPG [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in post-prandial glucose /glucose excursions during a standardized meal test (subset of patients) [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in insulin glargine dose [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Daily dose of insulin glulisine [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Total daily dose of insulin [ Time Frame: week 26 ] [ 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: 26 weeks ] [ Designated as safety issue: Yes ]
  • Severe hypoglycemia [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

Primary Objective:

- To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

- To compare the treatments/regimens on:

  • The percentage of patients reaching the target of HbA1c <7% or ≤6.5%
  • Body weight
  • Self-Monitored Glucose profiles
  • Fasting Plasma Glucose (FPG)
  • Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients)
  • Daily doses of insulins
  • Safety and tolerability

Approximately 41 weeks including a 26 week treatment period

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: lixisenatide (AVE0010)

    Pharmaceutical form:solution for injection (disposable self injector)

    Route of administration: subcutaneous injection

  • Drug: insulin glulisine (HMR1964)

    Pharmaceutical form:solution for injection (disposable self injector)

    Route of administration: subcutaneous injection

    Other Name: Apidra©
  • Experimental: lixisenatide
    lixisenatide once a day (injected before breakfast or dinner) on top of insulin glargine with or without metformin. Starting dose will be 10µg, then increased to the 20µg maintenance dose after 2 weeks
    Intervention: Drug: lixisenatide (AVE0010)
  • Active Comparator: insulin glulisine once a day
    Insulin glulisine once a day (injected before breakfast or dinner) on top of insulin glargine with or without metformin. Treatment will be initiated and then individually titrated
    Intervention: Drug: insulin glulisine (HMR1964)
  • Active Comparator: insulin glulisine three times a day
    Insulin glulisine three times a day (injected before breakfast, lunch and dinner) on top of insulin glargine with or without metformin. Treatment will be initiated and then individually titrated
    Intervention: Drug: insulin glulisine (HMR1964)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
855
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion criteria :

  • Patients with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1) .
  • Patients treated with basal insulin for at least 6 months.
  • Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20 %) and ≥20 U/day for at least 2 months prior to visit 1.
  • Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (≥1.5g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria:

  • At screening: age < legal age of majority
  • At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP-4 inhibitor and/or a glinide.
  • Women of childbearing potential with no effective contraceptive method, pregnancy or lactation
  • Type 1 diabetes mellitus
  • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.
  • Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
  • Any previous treatment with lixisenatide, or any discontinuation from another GLP-1 receptor agonist due to safety/tolerability issue or lack of efficacy.
  • At screening, Body Mass Index (BMI) ≤20 or >40 kg/m².
  • Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
  • Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
  • At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 95 mmHg
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
  • Contraindication related to metformin (for patient receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
  • Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
  • At screening, amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN)
  • At screening ALT or AST>3ULN
  • At screening calcitonin ≥20 pg/ml (5.9 pmol/L)

Exclusion Criteria for randomization at the end of the screening period before randomization:

  • HbA1c <7.0% or >9.0%.
  • 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).
  • Amylase and/or lipase > 3 times ULN.

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Chile,   Czech Republic,   Estonia,   France,   Germany,   Hungary,   Italy,   Latvia,   Lithuania,   Mexico,   Poland,   Romania,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
 
NCT01768559
EFC12626, 2012-004096-38, U1111-1131-4936
No
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