Phase 3
Completed N=451
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
Source: ClinicalTrials.gov NCT01517412 ↗Enrolled (actual)
451
Serious AEs
3.1%
Results posted
Oct 2016
Primary outcomePrimary: Change in HbA1c From Baseline to Week 24 — -0.65; -0.74 Percentage of hemoglobin — p=0.2664
◆ Published Evidence
Emerging
19citations · ~2 / year
Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day.
Summary
Primary Objective:
- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)
Secondary Objective:
* To assess the effect of the 2 lixisenatide regimens on:
* The percentage of participants who reached the target of HbA1c < 7% or ≤ 6.5% at Week 24
* Fasting Plasma Glucose (FPG)
* 7-point Self-Monitored Plasma Glucose (SMPG) profiles
* Body weight
* To assess the safety and tolerability of the 2 lixisenatide regimens
Linked Publications
-
Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 24 |
-0.65; -0.74 | 0.2664 |
| SECONDARY Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24 |
43.6; 42.8; 22.5; 25.7 | — |
| SECONDARY Change in Average 7-point SMPG Profiles From Baseline to Week 24 |
-0.80; -1.10 | — |
| SECONDARY Change in FPG From Baseline to Week 24 |
-0.35; -0.57 | — |
| SECONDARY Change in Body Weight From Baseline to Week 24 |
-2.60; -2.80 | — |
| SECONDARY Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period |
40.4; 41.0 | — |
| SECONDARY Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 |
40.8; 38.6 | — |
| SECONDARY Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period |
38.1; 37.2 | — |
| SECONDARY Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24 |
28.9; 27.6 | — |
| SECONDARY Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24 |
3.01; 3.54 | — |
Eligibility Criteria
Inclusion criteria
- Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit
- Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.
Exclusion criteria
- Screening HbA1c 10.0%
- Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)
- Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
- Participants who usually did not eat breakfast
- Type 1 diabetes mellitus
- Body Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2
- Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening
- Alanine aminotransferase (ALT) > 3 ULN at screening
- Calcitonin ≧ 20 pg/ml (5.9 pmol/L) 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)
- Any contra-indication related to metformin
- Any previous treatment with lixisenatide
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01517412) 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.