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 currently recruiting participants.
Verified April 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01768559
First received: January 11, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes
Drug: lixisenatide (AVE0010)
Drug: insulin glulisine (HMR1964)
Phase 3

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 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 855
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: lixisenatide (AVE0010)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

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
Drug: insulin glulisine (HMR1964)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Other Name: Apidra©
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
Drug: insulin glulisine (HMR1964)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Other Name: Apidra©

Detailed Description:

Approximately 41 weeks including a 26 week treatment period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768559

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 203 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01768559     History of Changes
Other Study ID Numbers: EFC12626, 2012-004096-38, U1111-1131-4936
Study First Received: January 11, 2013
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin glulisine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014