Phase 3
Completed N=894
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Source: ClinicalTrials.gov NCT01768559 ↗Enrolled (actual)
894
Serious AEs
4.0%
Results posted
Jan 2017
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.63; -0.58; -0.84 percentage of hemoglobin
◆ Published Evidence
Highly cited
130citations · ~13 / year
Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.
Summary
Primary Objective:
- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.
Secondary Objectives:
- To compare the treatments/regimens on:
* The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,
* Body weight,
* Self-Monitored Glucose profiles,
* Fasting Plasma Glucose (FPG),
* Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),
* Daily doses of insulins,
* Safety and tolerability.
Linked Publications (3)
-
Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.
-
Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis.
-
Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-0.63; -0.58; -0.84 | — |
| PRIMARY Change in Body Weight From Baseline to Week 26 |
-0.63; 1.03; 1.37 | < 0.0001 sig |
| SECONDARY Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26 |
20.5; 17.8; 30.8; 42.1; 38.4; 49.2 | — |
| SECONDARY Percentage of Participants With no Weight Gain at Week 26 |
64.7; 36.6; 30.5 | — |
| SECONDARY Change in Average 7-point SMPG Profiles From Baseline to Week 26 |
-0.784; -0.782; -1.053 | — |
| SECONDARY Change in FPG From Baseline to Week 26 |
-0.23; -0.21; -0.06 | — |
| SECONDARY Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast) |
-3.93; -1.62; -1.87 | — |
| SECONDARY Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast) |
-3.42; -1.59; -1.56 | — |
| SECONDARY Change in Insulin Glargine Dose From Baseline to Week 26 |
0.7; -0.06; -3.13 | — |
| SECONDARY Insulin Glulisine Dose at Week 26 |
9.97; 20.24 | — |
| SECONDARY Total Insulin Dose at Week 26 |
73.61; 81.05 | — |
| SECONDARY Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia |
31.5; 37.5; 44.6; 0; 0.7; 0 | — |
| SECONDARY Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period |
29.4; 24.2; 26.1 | — |
| SECONDARY Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26 |
31.2; 16.7; 17.6 | — |
| SECONDARY Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period |
22.2; 9.2; 10.8 | — |
Eligibility Criteria
Inclusion criteria
- Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1).
- Participants treated with basal insulin for at least 6 months.
- Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. 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.
- Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/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 10.0% for participants treated with basal insulin alone or in combination with metformin only; 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included 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 glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.
- At screening, Body Mass Index (BMI) ≤20 or >40 kg/m^2.
- 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 predisposed to MTC (e.g. multiple endocrine neoplasia syndromes).
- Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
- Participants 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 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
- At screening calcitonin ≥20 pg/ml (5.9 pmol/L).
Exclusion Criteria for randomization at the end of the screening period before randomization:
- HbA1c 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 participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01768559) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.