Phase 2
Completed N=323
Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
Source: ClinicalTrials.gov NCT01476475 ↗Enrolled (actual)
323
Serious AEs
4.6%
Results posted
Feb 2017
Primary outcomePrimary: Change in HbA1c From Baseline to Week 24 — -1.82; -1.64 percentage of hemoglobin — p=0.0130
Summary
Primary Objective:
* The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.
Secondary Objectives:
* To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:
* Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
* Percentage of participants reaching HbA1c <7% or ≤6.5%;
* 7-point Self-Monitored Plasma Glucose (SMPG) profile;
* Body weight;
* Insulin glargine dose
* Fasting Plasma Glucose (FPG);
* Percentage of participants requiring rescue therapy during the 24-week open label treatment period;
* To assess safety and tolerability of insulin glargine/lixisenatide FRC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 24 |
-1.82; -1.64 | 0.0130 sig |
| SECONDARY Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24 |
-7.49; -4.33 | <0.0001 sig |
| SECONDARY Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24 |
-3.91; -0.67 | <0.0001 sig |
| SECONDARY Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24 |
-3.23; -2.93 | 0.0154 sig |
| SECONDARY Change in Body Weight From Baseline to Week 24 |
-0.97; 0.48 | <0.0001 sig |
| SECONDARY Average Daily Insulin Glargine Dose at Week 24 |
36.08; 39.32 | 0.0583 |
| SECONDARY Change in FPG From Baseline to Week 24 |
-3.35; -3.51 | — |
| SECONDARY Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period |
0; 0.6 | — |
| SECONDARY Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24 |
71.9; 64.6; 84.4; 78.3 | — |
| SECONDARY Change in 30-minute and 1-hour PPG From Baseline to Week 24 |
-5.01; -3.76; -5.94; -4.10 | — |
| SECONDARY Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24 |
-1.47; -0.05; -2.34; -0.44 | — |
| SECONDARY Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period |
67.5; 59.0 | — |
| SECONDARY Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 |
56.3; 37.3 | — |
| SECONDARY Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia |
21.7; 22.8; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion criteria
- Participants with type 2 diabetes mellitus diagnosed for at least 1 year.
- Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening.
Exclusion criteria
- Age 10%.
- Screening FPG >250 mg/dL (>13.9 mmol/L).
- Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
- Type 1 diabetes mellitus.
- Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.
- Use of insulin within the last 6 months.
- Previous use of insulin, except for episode(s) of short-term treatment (≤15 consecutive days) due to intercurrent illness.
- Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN) at screening.
- Calcitonin ≥20 pg/ml (5.9 pmol/l) at screening.
- Alanine Transferase (ALT) >3 ULN at screening.
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).
- Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively.
- Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures.
- Body Mass Index (BMI) ≤20 or >40 kg/m^2.
- Any previous treatment with lixisenatide
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 (NCT01476475). 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.