Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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: December 2014
Estimated Primary Completion Date: December 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
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: NCT01768559

  Show 199 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: July 16, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014