GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea (GETGOAL-L-ASIA)

NCT00866658 | Completed Phase 3 Results

• 1 other identifier: EFC10887
• Study Type: interventional
• Target: 311
• Locations: 4 countries
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without sulfonylurea, over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide, when added to basal insulin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24. The secondary objectives are to assess the effects of lixisenatide on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in daily basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK), and anti-lixisenatide antibody development.

Conditions

Diabetes Mellitus, Type 2

Keywords

hyperglycemia; GLP-1; sulfonylurea; insulin

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

  Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.

  Baseline, Week 24

Secondary Outcomes (8)

• Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24

  Baseline, Week 24

• Change From Baseline in Body Weight at Week 24

  Baseline, Week 24

• Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24

  Baseline, Week 24

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline, Week 24

• Change From Screening in Total Insulin Dose at Week 24

  Screening, Week 24

Other Outcomes (3)

• Change From Baseline in Glucose Excursion at Week 24

  Baseline, Week 24

• Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24

  Baseline, Week 24

• Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia

  First dose of study drug up to 3 days after the last dose administration

Study Arms (2)

Lixisenatide

EXPERIMENTAL

2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.

Drug: Lixisenatide (AVE0010); Device: Pen auto-injector; Drug: Sulfonylurea; Drug: Basal Insulin

Placebo

PLACEBO COMPARATOR

2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.

Drug: Placebo; Device: Pen auto-injector; Drug: Sulfonylurea; Drug: Basal Insulin

Interventions

Lixisenatide (AVE0010) DRUG

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Lixisenatide

Placebo DRUG

Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

Placebo

Pen auto-injector DEVICE

Also known as: OptiClik®

Lixisenatide; Placebo

Sulfonylurea DRUG

Sulfonylurea if given, to be continued at a stable dose.

Lixisenatide; Placebo

Basal Insulin DRUG

To be continued at a stable dose.

Lixisenatide; Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin with or without sulfonylurea

You may not qualify if:

• HbA1c less than (\<) 7 percent (%) or greater than (\>) 10% at screening
• At the time of screening age \<legal age of majority
• Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
• Type 1 diabetes mellitus
• Treatment with basal insulin for less than 3 months prior to screening or insulin regimen changed during the last 3 months prior to screening
• Basal insulin dose at screening \<10 units/day and/or during the last 2 months dose not stable (+/- 20%)
• Sulfonylurea not at a stable (unchanged) dose for at least 3 months prior to screening
• FPG at screening \>250 milligram/deciliter (mg/dL) (\>13.9 millimole/liter \[mmol/L\])
• History of hypoglycemia unawareness
• Weight change of more than 5 kilogram (kg) during the 3 months preceding the screening visit
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
• History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
• Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening
• Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
• Known history of drug or alcohol abuse within 6 months prior to the time of screening

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

Sanofi-Aventis Administrative Office

Makati City, Philippines

Location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

Sanofi-Aventis Administrative Office

Taipei, Taiwan

Location

Related Publications (3)

• Seino Y, Min KW, Niemoeller E, Takami A; EFC10887 GETGOAL-L Asia Study Investigators. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012 Oct;14(10):910-7. doi: 10.1111/j.1463-1326.2012.01618.x. Epub 2012 May 30.

  PMID: 22564709 RESULT

• Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Clin Diabetes Endocrinol. 2020 Jan 14;6:2. doi: 10.1186/s40842-019-0088-5. eCollection 2020.

  PMID: 31956422 DERIVED

• Seino Y, Ikeda Y, Niemoeller E, Watanabe D, Takagi H, Yabe D, Inagaki N. Efficacy and Safety of Lixisenatide in Japanese Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin+/-Sulfonylurea: A Subanalysis of the GetGoal-L-Asia Study. Horm Metab Res. 2015 Nov;47(12):895-900. doi: 10.1055/s-0035-1549875. Epub 2015 Jun 3.

  PMID: 26039935 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Insulin Resistance

Interventions

lixisenatide; Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-us@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 11, 2016
• Results First Posted: October 11, 2016

Record last verified: 2016-08

Locations

TW (1); PH (1); JP (1); KR (1)